A N N U A L

R E P O R T

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Vision: Our aim is to create a world free from gastro-intestinal cancers.

Mission: We put patients with gastro-intestinal cancer at the centre of our research, saving and improving lives by accelerating the pace of discoveries that lead to cures. Our dedicated group of research and health professionals translate bold new ideas into life-saving clinical trials that help those patients as quickly as possible.

2 Year at a Glance5 About Us6 AGITG Award Winners9 Strategic Research Priorities & Activities10 Our Global Presence13 Our Members14 Chair’s Message17 Chief Executive Officer’s Report18 Group Coordinator’s Report21 Consumer Advisory Panel Report22 Research Development Strategy25 Improving Survival Rates for GI Cancer26 Clinical Trials27 Oesophageal Cancer28 Stomach Cancer, GIST & NETs30 Pancreatic, Gallbladder & Biliary Tract Cancer32 Colorectal & Anal Cancer

34 Endorsed Studies37 Translational Research38 AGITG Engaged Coordinating Centres40 Journal Publications & Conference Presentations 43 Genesis of a Clinical Trial45 Annual Scientific Meeting50 Investing in Research52 Grants54 Board of Directors59 Organisational Structure60 Scientific Advisory Committee & Working Parties 63 Treasurer’s Report64 Income Statement65 Balance Sheet67 Your Support Makes the Difference69 Honour Roll70 GI Cancer Institute Sponsors

Pictured Front Cover (L-R): Professor Val Gebski – John Zalcberg OAM Award, Professor Peter Gibbs – AGITG Innovation Fund Grant, Dr Ryan Cohen – Merck-AGITG Kristian Anderson Award, Dr Mark McGregor – Best New Concept Award, Dr Grace Gard – Best New Concept Award – Runner Up, Dr Simon Wilkins – Best Fast Forward Presentation Award, Dr Swetha Sridharan – Best Poster Award, Dr David Lau – 2018 Merck-AGITG Clinical Research Fellowship, Naomi Knoblauch – AGITG Outstanding Site, Professor Niall Tebbutt – AGITG Member Fundraiser of the Year.

AWARDWINNER

AGITG

2019

RECOGNISING OUTSTANDING LEADERSHIP

“It is an honour to receive the John Zalcberg OAM Award. I am proud to have contributed to research which has resulted in improvements in gastro-intestinal cancer treatment, and to have contributed to the design of high quality clinical trials resulting in international recognition of the excellence of AGITG.”

Professor Val GebskiJohn Zalcberg OAM Award for Excellence in AGITG Clinical Trials Research

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A G L A N C E

Y E A R A T

1. January• Pancreatic surgeon Professor

Jaswinder Samra (pictured), a member of the Upper GI Working Party, receives a Medal of the Order of Australia for his service to medicine as a pancreatic cancer specialist.

2. February• The AGITG Scientific Advisory

Committee announces nine research priorities for 2019, defining the key areas at the forefront of research and addressing the areas of greatest need.

3. March• The RENO study led by Professor

Chris Karapetis (pictured) activates its first site, Flinders Medical Centre in South Australia, and the first participant enrols in the study.

• 9-year-old Ella raises over $1,000 through her dance group in honour of her father who passed away from bile duct cancer in 2018.

4. April• The first ever AGITG trial site to open

in Japan is activated at National Cancer Centre East for the INTEGRATE II trial led by Associate Professor Nick Pavlakis (pictured) and local investigator Professor Kohei Shitara.

5. May• AGITG Directors Dr Lorraine

Chantrill and Professor Stephen Ackland discuss AGITG research with community members at the Living Room Series (pictured).

6. June• The preliminary results of the phase

II ALT-GIST study are presented as a poster at the American Society of Clinical Oncology Annual Meeting by Professor Desmond Yip.

• Clinical Research Fellow Dr Zarka Samoon (pictured) is welcomed to the AGITG.

• The inaugural AGITG Idea Generation Workshop is held in Sydney with convenors Professor Martin Stockler and Associate Professor Mustafa Khasraw. Ten early-stage research ideas are

discussed and developed.

7. July• Led by Professor Niall Tebbutt

(pictured), the LIBERATE study of liquid biopsy technology for patients with advanced colorectal cancer reaches its target of 100 patients and moves into the follow-up phase.

8. August• The AGITG Annual Scientific

Meeting is held in Adelaide, with the theme ‘Challenging the enigmatic nature of gastro-intestinal cancers’. The Best New Concept Award was presented to Dr Mark McGregor, and the Best of Posters Award was presented to Dr Swetha Sridharan (pictured).

• Professor Peter Gibbs receives the AGITG Innovation Fund grant of $200,000 for his study ‘FORECAST-1: An organoid sensitivity testing driven umbrella study for patients with chemorefractory metastatic colorectal cancer.’

9. September• The Cape to Cape Gutsy Challenge

Adventure team (pictured), led by Dr Lorraine Chantrill, completes a 100km trek and raises over $101,000 for research.

• Community fundraisers in the Westpac City to Bay fun run raise $3,500 for gastro-intestinal cancer research.

10. October• The MASTERPLAN phase II trial

of mFOLFIRINOX and stereotactic body radiotherapy (SBRT) for patients with pancreatic cancer opens its first site at Princess Alexandra Hospital, Queensland, led by Dr Andrew Oar (pictured).

11. November• Four men who have lost their

wives to pancreatic cancer (pictured) share their stories to raise awareness and funds during Pancreatic Cancer Awareness Month.

• The PALEO trial becomes the first AGITG-endorsed study to open and recruit its first patient, investigating the effects of the addition of SBRT to treatment with nivolumab in people with metastatic oesophageal cancer.

• Professor Tim Price leads a Gutsy Challenge team over 70km through New Zealand’s Southern Alps, raising close to $75,000 in collaboration with the New Zealand Gut Cancer Foundation team.

• Macquarie Bank raises over $82,000 in their annual trivia night in memory of Andrew Watson who passed away from oesophageal cancer earlier in 2019.

• Community fundraisers running Point to Pinnacle in Hobart raise over $9,000 to fund biliary tract cancer research.

• Community Fundraisers running Point to Pinnacle in Hobart raise over $9,000 to fund biliary tract cancer research.

12. December• The Scientific Advisory Committee

determines the AGITG Research Priorities for 2020.

• The CommNETs annual research workshop (pictured) is held in Tokyo, Japan, involving AGITG researchers from Australia and New Zealand and Canadian researchers from the Canadian Cancer Trials Group.

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7 8 9 10 11 12

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“Being awarded the Merck-AGITG Clinical Research Fellowship at the Royal Marsden Hospital, UK, is an excellent opportunity to hone both my clinical and research methods amongst eminent experts in GI cancer.”

AWARDWINNER

AGITG

Dr David Lau2018 Merck-AGITG Clinical Research Fellowship

ABOUT US

28 years of ground-breaking

AGITG research

6,600+ patientsgiven access to new treatment

regimens on our trials

$70 million invested in

AGITG research

133 research articles published in peer reviewed journals

by AGITG researchers, changing medical practice

58 clinical trialsimproving outcomes for people with GI cancer

228 presentations based on AGITG trials at global

research conferences

Since 1991, our key priority has been to undertake research that is centred on patient care and to improve medical care and medical practice in the treatment of gastro-intestinal (GI) cancers.

We put patients with GI cancer at the centre of our research, saving and improving lives by accelerating the pace of discoveries that lead to cures.

Our dedicated group of research and health professionals translate bold new ideas into life-saving clinical trials that help those patients as quickly as possible.

As a result, the Australasian Gastro-Intestinal Trials Group (AGITG) has been integral to worldwide changes in medical practice in a number of GI cancers, including gastric, pancreatic, colorectal, oesophageal and biliary tract cancers as well as gastro-intestinal stromal tumours (GIST). The Group has led trials in the

treatment of stomach and rectal cancer and established surgical guidelines in Australia for pancreatic cancer.

We are a multi-disciplinary collaborative group of medical oncologists, radiation oncologists, surgeons, statisticians, data managers, allied health care professionals and health consumers. Our research focuses on the GI cancers: oesophageal, stomach, liver, pancreas, gallbladder and biliary tract, large bowel, small bowel, rectal and anal cancer, as well as GIST and neuroendocrine tumours (NETs).

The GI Cancer Institute is the community division of the AGITG, working across Australia to raise funds and awareness of GI cancer and clinical trials.

Significant achievements in medical practiceWe have extended life expectancy for patients with GI cancer by testing: • Oral chemotherapy as an

alternative to intravenous therapies

• New drug treatments• Targeted and personalised

therapies• Preoperative chemoradiation• Novel combinations of treatmentsWe have improved quality of life for patients with GI cancer by:• Reducing side effects by using

a different combination of chemotherapies

• Identifying patients who do not benefit from certain therapies

• Demonstrating that a shorter duration of treatment is equally efficacious but less toxic in the adjuvant treatment of colorectal cancer

We have tested new targeted therapies for GI cancers:• Demonstrating that a drug that acts

on tumour growth is safe and active in oesophageal cancer

• Showing that a monoclonal antibody treatment is likely to benefit selected patients with bile duct cancer.

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4 5

AWARDWINNER

AGITG

2019

“It was an honour to receive this award and I am thrilled to have this support for my research. I hope that it can bring us one step closer to finding better treatments for people with bowel cancer.”

Dr Ryan CohenMerck-AGITG Kristian Anderson Award

A G I T G

A W A R D

W I N N E R S

The people who innovate and drive change in gastro-intestinal (GI) cancer treatment deserve reward and opportunity. The grants and awards offered by the AGITG recognise original ideas that have the potential to change medical practice, giving researchers the funding and platform they need to translate their ideas into practice.

Elevating great ideas is integral to ensuring the AGITG continues to conduct research and clinical trials that save, extend and improve the lives of people with GI cancers.

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Foster multidisciplinary,

national and international collaboration

Optimise resources by maintaining

efficient and cost-effective governance processes

Proactively build our

trial portfolio

1 3Develop and support the membership

4 5Improve patient

outcomes by maximising recruitment and funding

opportunities

2

Strategic Research Priorities

Our priorities address the current gastro-intestinal (GI) cancer trials landscape including developments in health and medical research relevant for the conduct of collaborative clinical trials in Australasia.

The organisation’s research priorities are set by the Scientific Advisory Committee, defining key areas of greatest need in the current GI Cancer landscape and strategic initiatives to explore development of relevant scientific research.

Strategic Activities

STRATEGIC RESEARCH PRIORITIES & ACTIVITIES

Thinking “outside the box” for appropriate new areas for research, including pharmacogenomics, pre-habilitation, and nutrition.

Foster innovation and develop novel approaches for:• Prevention, screening, diagnosis, treatment and control • Treatment modalities• Genomics • Investigating cancer biology.

Investigating collaborative approaches and potential future funding opportunities for rare cancers.

Investigate national and international funding and collaboration opportunities relevant for rare cancers, and develop a rare cancer model for AGITG.

Developing concepts in the rectal cancer space.

Current treatment favours early diagnosis, therefore developing concepts in rectal cancer is a priority to improve management.

Designing clinical trials in HCC and liver SBRT.

Design clinical trials in Hepatocellular Carcinoma (HCC) including treatment strategies with Stereotactic Body Radiation Therapy (SBRT).

Building rare cancer international collaborations for tumour streams and rare basket studies.

Engage international collaborators to develop basket and umbrella trials in rare cancers to enhance feasibility.

Mapping and summarising trial activity elsewhere, using this to inform future research opportunities.

Map national and international GI cancer clinical trial activity to ascertain current landscape and pro-actively contribute to idea generation.

Developing registry-based trials.

Develop pragmatic clinical trial paradigms to enhance generalizability to real-world patients, site participation and participant recruitment, reduce cost and research waste. Examples of such trial designs include:• Registry-based randomised trials • Adaptive platform trials • Observational studies.

Developing late-stage trials, particularly colorectal.

Current treatment favours early diagnosis, therefore developing concepts in colorectal cancer is a priority to improve management.

Incorporating patient-reported outcomes (PROs) into existing and new studies.

Integration of quality of life or other patient-reported outcomes (PROs) during concept development.

AWARDWINNER

AGITG

2019

Dr Swetha Sridharan Best Poster Award

8 9

The AGITG plays a major role in clinical trial research on the global stage and has international collaboration links with Europe, Asia and North America.

113 Participating CentresClinical trials in recruitmentACTICCA-1, ASCOLT, DYNAMIC-III, DYNAMIC-Rectal, DYNAMIC-Pancreas, INTEGRATE II, MASTERPLAN MODULATE, MONARCC, NABNEC, SPAR, TOPGEAR

Clinical trials in follow-upALaCaRT, ALT-GIST, CONTROL NETS, LIBERATE, DOCTOR

Clinical trials Recruiting – EndorsedPALEO, Neo-CREATE, RENO

32 Participating CentresClinical trials in recruitmentINTEGRATE II

Clinical trials in follow-up ALT-GIST

24 Participating CentresClinical trials in recruitmentINTEGRATE II, TOPGEAR

�3 Participating CentresClinical trials in recruitmentTOP GEAR

Clinical trials in follow-up ALT-GIST

8 Participating CentresClinical trials in recruitmentACTICCA-1, ASCOLT, DYNAMIC-III, INTEGRATE II, SPAR, TOPGEAR

Clinical trials in follow-upALaCaRT

8 Participating CentresClinical trials in recruitmentTOP GEAR

Clinical trials in follow-up ALT-GIST

6 Participating CentresClinical trials in recruitmentINTEGRATE II

CanadaUK

USA Asia

Australia NZ

Europe

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Australia

Asia New Zealand

Canada

Europe

UK

USA

OUR GLOBAL PRESENCE

AWARDWINNER

AGITG

2019

“The benefit of an award like this is it allows us to present these new concepts and collaborate with our colleagues to get research off the ground and attract further support.”

Dr Mark McGregor Best New Concept Award

10 11

AGITG membership encompasses a wide range of medical specialists, scientists, nurses, allied health professionals and health consumers. We have over 1,300 members from Australia, New Zealand and around the world.

20191,338 members

20181,167 members

MEMBERSHIP

UP 14%

A DB C E F G H

446

136

271

185

104

83

21

I

10

82

Members – Disciplines A. Medical OncologistsB. Trial Co-ordinators &

Data ManagersC. SurgeonsD. NursesE. Radiation OncologistsF. Allied Health ProfessionalsG. ScientistsH. Health ConsumersI. Students/PhD Trainees

OUR MEMBERS

AWARDWINNER

AGITG

2019

Dr Grace Gard Best New Concept Award – Runner Up

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Each new practice-changing treatment that we develop is a testament to the teams that collaborate and improve survival rates.

This collaboration is key to our mission, and it is integral to our priorities going forward. International collaboration in rare cancer studies has been at the forefront this year. The INTEGRATE II study for gastro-oesophageal cancer became the first AGITG trial to open in Japan in February at National Cancer Centre East, led by local investigator Professor Kohei Shitara. Our clinical trials are now open in sites across the Asia Pacific region, the United Kingdom, Europe and North America, offering new treatment options to patients worldwide.

The AGITG clinical trials portfolio has continued to grow this year, offering new treatments in areas of unmet need. The MASTERPLAN trial for patients with pancreatic cancer and the RENO trial for patients with rectal cancer have both opened this year. The LIBERATE study, investigating liquid biopsies as an alternative method of determining RAS mutation in patients with advanced colorectal cancer, reached its enrolment target.

Specialists from numerous disciplines are vital to our research, and I am always honoured to recognise their work. In 2019 Professor Val Gebski was awarded the Professor John Zalcberg OAM Award for Excellence in AGITG

Research for his work as a senior statistician. Professor Gebski has helped to shape every AGITG study conducted through the University of Sydney’s Clinical Trials Centre. Our sincere congratulations to Professor Gebski, and thanks for his countless contributions to AGITG research.

In May 2020, I will be stepping down as Chair of the AGITG and GI Cancer Institute. In the six years I have been in this role, it has been extraordinary to see how much we have achieved. The results of 37 AGITG-sponsored clinical trials have been published or presented in Australia and around the world, sharing research that has led to changes in practice for many gastro-intestinal (GI) cancers. The AGITG Innovation Fund was launched in 2014, providing two research grants of $50,000 each, and has now grown to a $200,000 grant. We have been able to offer awards and opportunities to our members, like the Merck-AGITG Clinical Research Fellowship and Kristian Anderson Award for early career researchers, and the AGITG Fundraiser of the Year Award which was first implemented last year. Community support has grown, with more supporters taking on the Gutsy Challenge to raise awareness and funds for clinical trials.

Congratulations to Chair-Elect Dr Lorraine Chantrill, who will take up the position in May 2020. I am confident the AGITG will continue to make breakthroughs where treatments are needed most for

patients with GI cancers under her leadership.

Our GI cancer community is growing, as is awareness of the value of our work. Whether it is developing and conducting research, trekking along the Western Australian coastline or hiking over New Zealand’s Southern Alps, the tireless efforts of everyone who works with and supports the AGITG and GI Cancer Institute are vital to improving outcomes for our patients. Although it is not possible to list you all, I would like to thank you wholeheartedly for your dedication to changing the outcomes for the patients who are always at the centre of our research.

Professor Tim PriceMBBS DHthSc (Med) FRACP Chair

CHAIR’S MESSAGE

Each clinical trial the AGITG conducts includes a multitude of people, working across disciplines, institutions and even countries.

“Our strategic and research priorities have been developed with the ultimate goal of improving patient outcomes. We are looking to the future to ensure that we continue to conduct innovative and ground-breaking research that improves the treatment options and outcomes for patients with GI cancers.”

Professor Tim PriceChair

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Russell ConleyChief Executive Officer

As discoveries are made that change the way gastro-intestinal cancers are understood, the scope of AGITG research expands.

In 2019, the AGITG implemented new strategic activities to accelerate the pace of discovery and connect researchers working across institutions and disciplines.

The challenges of treating gastro-intestinal (GI) cancers are vast and the impact that these diseases have is devastating. However, the survival outcomes for people diagnosed with all 10 GI cancers continued to improve this year. Colon cancer now has a five-year survival rate of 70%, compared to just over 50% in 1991, when the AGITG first formed. The five-year survival rate for pancreatic cancer is now almost 10%, meaning that three times as many patients are surviving this disease as did thirty years ago. These improvements are due to the dedicated efforts of the whole community who have been unwavering in their support of patients.

The 2018-2022 AGITG Strategic Plan entered its second year of implementation in 2019. Our central focus this year has been on pro-actively building our clinical trials portfolio, fostering national and international multidisciplinary engagement and collaborations, and maintaining efficient and cost-effective AGITG structures and processes that make optimal use of our resources.

In 2019, the AGITG pro-actively increased our clinical trials portfolio with the inaugural Idea Generation Workshop, held on 21 June. At the workshop, ten early-stage research ideas were discussed to determine the best direction

for their development. Four of the ideas presented were then further developed through the Upper and Lower GI Working Parties, where they received feedback for further advancement.

To foster multidisciplinary engagement and collaborations aligned with our strategic objectives, the Endorsed Study Model was implemented in 2019. The first two Endorsed studies, PALEO and Neo-CREATE, have opened – under this new model, AGITG provides support to the sponsoring institution. We do this by conducting feasibility surveys, advertising the study on the AGITG website, inviting presentations at the Annual Scientific Meeting, and providing consumer review and feedback.

International collaboration was also a core focus. AGITG trials were opened in nine countries around the world in 2019. Our research was also presented and published internationally, with five publications and five conference presentations for TOPGEAR, ALT-GIST, INTEGRATE II, ALaCaRT, MAX and MASTERPLAN.

Making optimal use of available resources has been a high priority. To gain more value from AGITG studies that have closed, the Translational Research Model was activated. This enables scientists conducting research to access stored biological specimens from closed studies, to develop better treatments for patients. This model facilitates the development of new research ideas and connects clinical and scientific research.

The role of the Consumer Advisory Panel (CAP) also expanded in 2019, with more CAP members participating in Trial Management Committees to consult on trial design and operations. The CAP also conducted a record 13 concept reviews. The members of this panel never hesitate to roll up their sleeves and take on big issues to ensure that the voices of GI cancer patients and carers are always heard.

The issue of treatment disparity for neglected GI cancers hit a nerve in the media, particularly during November, which is Pancreatic Cancer Awareness Month. The level of awareness and the need to tackle these devastating cancers head on is growing in our community. As a result, the Scientific Advisory Committee identified the Neo-IMPACT trial investigating pancreatic cancer treatments as an AGITG priority to be funded by philanthropic and community based funding streams.

Over 28,900 Australians are diagnosed with a GI cancer every year. However, thanks to the unparalleled dedication of the GI cancer research community, the odds for survival are rising. The help of patients, families, survivors, carers, donors and supporters, as well as medical professionals, is making a real difference, and I have great hope for the future.

Russell Conley Chief Executive Officer FIML MFIA MAICD

CHIEF EXECUTIVE OFFICER'S REPORT

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In 2019, the AGITG clinical trials portfolio continued to address areas of unmet need as defined by the research priorities identified earlier in the year.

GROUP COORDINATOR’S REPORT

This year the AGITG activated the RENO and MASTERPLAN trials. RENO is assessing the safety of the ‘watch and wait’ approach for patients with locally advanced rectal cancer who have completed chemoradiation treatment. MASTERPLAN is determining whether adding stereotactic body radiotherapy (SBRT) to chemotherapy improves the control of patients with high-risk, borderline resectable pancreatic cancer and locally advanced pancreatic cancer.

The LIBERATE study, investigating “liquid biopsies” as a method of evaluating RAS mutation status in patients with advanced colorectal cancer, reached its enrolment target in July 2019. CONTROL NETS, which is finding the optimal treatment to improve disease control in patients with advanced neuroendocrine tumours (NETs), reached its primary endpoint analysis in the second half of the year.

These studies reflect the diverse portfolio of the AGITG: they offer options for patients with pancreatic cancer, NETs and colorectal cancer, exploring new ways of treating patients with chemotherapy, radiotherapy and surgery.

The AGITG has published new study findings in five peer-reviewed journal articles and made five international conference presentations this year. This included the publication of the results of the DOCTOR trial in Annals of Oncology. Professor Desmond Yip presented the primary endpoint results of ALT-GIST at the American Society of Clinical Oncology Annual Meeting 2019 sarcoma poster discussion session. Dr Yu Jo Chua presented the INTEGRATE II study at the Japanese Society of

Medical Oncology Annual Meeting this year.

This was not the only connection with Japan for INTEGRATE II – it became the first AGITG trial to have a study open in Japan at National Cancer Centre East under Professor Kohei Shitara.

FORECAST-1, led by Professor Peter Gibbs, was awarded the 2019 Innovation Fund grant at the Annual Scientific Meeting in August. This ‘bucket’ clinical trial will genetically interrogate individual cancers, with treatment individually allocated according to the results of these analyses. This trial will contribute to a new development in precision oncology for advanced colorectal cancer, thereby personalising treatment. Dr Mark McGregor was awarded the 2019 Best New Concept Award for ‘A phase II study of oncolytic immunotherapy of metastatic neuroendocrine tumours using intralesional rose bengal disodium in combination with pembrolizumab’.

In December, the phase III ASCOLT trial was successful in securing a grant from Cancer Australia through the Priority-driven Collaborative Cancer Research Scheme. This will provide three years of further funding, enabling more patients to join the trial. ASCOLT is evaluating the safety and effectiveness of low-dose aspirin compared to placebo in reducing recurrence of colorectal cancer and improving survival for patients with Dukes C and high-risk Dukes B colorectal cancer. ASCOLT has recruited a total of 400 patients in Australia and New Zealand. In collaboration with the National Cancer Centre, Singapore, total recruitment is at 1,460/1,587, with

widespread involvement from China, Hong Kong, Indonesia, India, Sri Lanka, Korea, Malaysia, Saudi Arabia and Taiwan.

The POLEM trial, led by Professor Tim Price was awarded the MRFF International Clinical Trial Collaborations (ICTC) Grant Opportunity, continued collaboration with The Royal Marsden Hospital, UK.

The first AGITG Idea Generation Workshop was held in June. Ten early-stage research ideas were presented and discussed throughout the day to determine the best direction for future research. The Endorsed Study Model was also activated this year, with the PALEO study in oesophageal cancer and the NEO-CREATE study in oesophago-gastric cancer both opening as endorsed studies.

These efforts and the progress of the AGITG clinical trials portfolio would not be possible without the work of everyone who collaborates on our research program. Clinical investigators, research coordinators and staff across AGITG, the NHMRC Clinical Trials Centre, and all coordinating centres have contributed significantly to the successful outcomes of this research. Finally, I offer my heartfelt thanks and appreciation to the patients and their carers who support and contribute to AGITG trials.

Dr Katrin SjoquistBSc(Med) MBBS MClinT(R) FRACP Group Coordinator Dr Katrin Sjoquist

Group Coordinator

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CONSUMER ADVISORY PANEL REPORT

In 2019, health consumers have played a bigger role in the development of new trials, ensuring the voices of patients and carers are always heard.

It is always exciting to see the knowledge we have gained from our experiences implemented into clinical trial design, and to be able to provide a personal perspective. Throughout the year, the CAP participated in 13 research concept reviews, and CAP members sat on the trial management committees for nine trials. CAP members have also consulted on seven ideas that were presented at the inaugural AGITG Idea Generation Workshop in June.

I was so proud to see my fellow members of the CAP make history at the Idea Generation Workshop this year, when CAP Members Julie Marker and Brian Wall developed the idea, ‘Does anaemia worsen chemotherapy-induced peripheral neuropath (CIPN)?’ As Brian could not attend the meeting, Julie presented this to the researchers present. This marked the first time health consumers had developed and presented a research idea to an Australian Cooperative Cancer Trials Group – a remarkable achievement and evidence of the integration of the CAP within AGITG. Others who were present at the workshop and have an interest in this health condition spoke with Julie and Brian about developing the concept further.

This year, the Panel, led by Deputy

Chair Robin Mitchell, designed a one page summary of the MASTERPLAN Patient Information Consent Form which was approved for use by the Ethics Committee, and for roll out to all participating sites. This is a major milestone for the CAP in their consumer role, representing patients who are considering a clinical trial and now have access to an initial summary overview of the trial.

I also participated in the Annual Scientific Meeting (ASM) Executive Organising Committee. I would like to thank Grant Baker for representing the consumer view at the Joint Consumer & Study Coordinator Forum at the ASM. Deputy Chair Robin Mitchell and I contributed to the rankings for the selection of the AGITG Outstanding Site Award, Innovation Fund Grant, Merck-AGITG Kristian Anderson Award and posters for the 2019 ASM. The CAP again submitted an entry to the John Zalcberg OAM Award for Excellence in AGITG Research.

Robin and I have participated in scheduled Upper and Lower GI Working Party Meetings throughout the year and other AGITG planning activities as needed.

Promoting the AGITG in the community has always been a key part of the Panel’s role, and this year was no exception. Robin Mitchell presented a bowel cancer information session to the North Epping Probus Club this year, and Gill Worden hosted a donor stewardship

dinner in Brisbane. James Armstrong coordinated and hosted a ‘Gutsy’ movie night fundraiser in Melbourne in November to support the upcoming Mt Himlung Himal Gutsy Challenge in Nepal.

I attended the Clinical Oncology Society of Australia’s Survivorship Conference, with Panel Deputy Chair Robin Mitchell and AGITG Director Dan Kent in Sydney in March. Robin and I also attended the workshop ‘Understanding Health Economics In Cancer Research’ held by the Cancer Research Economics Support Team (CREST), and have encouraged other CAP members to participate in this workshop.

I would like to thank the AGITG CAP for their contributions in 2019 and to AGITG for the opportunity to promote the value of health consumers in their research work. I am looking forward to 2020 with new milestones in research and improving the outcomes of those diagnosed with gastro-intestinal cancers.

Jan Mumford

Chair Consumer Advisory Panel

The role of the Consumer Advisory Panel (CAP) is increasingly integrated into AGITG clinical trials at every stage, from concept development through to reporting results.

Jan Mumford Chair, Consumer Advisory Panel

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We have a rich history of conducting practice changing clinical trials and innovative, pilot, interventional and translational research. Concepts are reviewed by the Upper and Lower GI Working Parties made up of AGITG members, all volunteers, who are health professionals based throughout Australia, and our Consumer Advisory Panel comprising gastro-intestinal (GI) cancer survivors, patients and carers. Concepts that address our research priorities are encouraged

Current forums for reviewing research include: 1. New Concepts Symposium,

presenting new concepts for feedback at the Annual Scientific Meeting.

2. AGITG Innovation Fund, providing an annual grant of up to $200,000.

3. Merck-AGITG Kristian Anderson Award, providing a grant of up to $36,700 to support the first year of MD or PhD research.

4. Idea Generation Workshop, where ideas are developed into research concepts for areas of unmet need.

5. Endorsed Study Model, supporting pilot trials sponsored by another institution.

6. Upper & Lower GI Working Parties, review all research concepts in development for scientific merit.

7. Translational Research Model, an opportunity to develop translational research in collaboration with basic scientists, preclinical and industry partners, by providing access to stored biological specimens acquired from studies that have subsequently closed.

8. Consumer Advisory Panel, reviews new trial concepts, identifies gaps in research and assists with developing lay language study documents.

1. Scientific Advisory Committee identifies

research priorities

4. Fund pilot studies

7. Generate & publish new evidence

6. Develop large scale clinical trial funding

submissions

New Research Development

Strategy

2. Develop new ideas

3. Develop new ideas into concepts

5. Generate proof of concept data

8. Improve patient health outcomes &

quality of life

• Working Parties• New Concepts Symposium

• Innovation Fund (Community Fundraising & Major Donors)• Major Donors• Industry Support• Government Grants• Foundation Grants

• Working Parties assist to develop large scale trial and provide recommendations to SAC for grant application

RESEARCH DEVELOPMENT STRATEGY

AWARDWINNER

AGITG

2019

Dr Simon Wilkins Best Fast Forward Presentation Award

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Pancreas

From

3%1982 - 1987

Up to

9.8%2019

Oesophagus

From

9.8%1982 - 1987

Up to

22%2019

Liver

From

7%1988 - 1993

Up to

18.5%2019

Gallbladder & Bile Duct

From

10%1982 - 1987

Up to

20.1%2019

Colorectal*

From

48%1982 - 1987

Up to

69%2019

Stomach

From

17%1982 - 1987

Up to

30.3%2019

IMPROVING SURVIVAL RATES FOR GI CANCER

Improved five-year survival rates* Colorectal cancer includes cancers of the colon and rectum.

Historical data for small bowel and anal cancer is not available.

AGITG clinical trials have contributed significantly to the improvement of outcomes for people with GI cancer. The estimated five-year survival rates for all GI cancers have improved, showing the positive outcomes of research.

AWARDWINNER

AGITG

2019

Naomi Knoblauch Calvary Mater Hospital Newcastle, Outstanding Site Award

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Oesophageal cancer in Australia continues to grow at an alarming rate. In 2011, there were 1,396 new diagnoses, and in 2019, there were 1,687 diagnoses and it claimed 1,470 lives. The five-year survival rate is only 22%.

Open to recruitmentINTEGRATE II There are currently few effective treatment options for patients with advanced gastro-oesophageal cancer (AGOC) that has returned after surgery, or where it is metastatic at diagnosis. Chemotherapy can be effective at first, but once the cancer has become resistant to it, the options for treatment are limited. For those who do receive additional courses of chemotherapy, their cancer will eventually become resistant (or ‘refractory’) to these drugs. In these situations, there are very few treatment options that have been shown to be both effective against the cancer and tolerable for

patients. Better treatment options are urgently needed.

The INTEGRATE II trial is testing regorafenib (BAY 73-4506), a 'multitargeted therapy' which targets a number of different signals in the cancer cell that cause it to grow and produce blood vessels. In other cancers, such as colon cancer and GIST, regorafenib has been proven to be of benefit when other drugs have ceased to work. The earlier AGITG phase II trial, INTEGRATE, demonstrated efficacy with the use of regorafenib in AGOC, and could potentially become a new standard of care after other therapeutic agents have stopped working. INTEGRATE II is being undertaken to confirm the findings of the phase II trial in a larger population. If the study is positive it will provide evidence for regorafenib as a new standard of care after other treatments no longer benefit patients with stomach cancer, also known as gastric cancer.

Following the promising results from the INTEGRATE study, INTEGRATE II, an AGITG-led phase III clinical trial in

gastro-oesophageal cancer, is open to patient participation in Australia, New Zealand, Korea, Canada, and Taiwan. The first patient on the study was recruited in October 2016 at Townsville Hospital, Queensland. Since that time, 27 sites have opened throughout Australia and New Zealand, which have recruited 42 patients, 18 sites in Korea, recruiting 68 patients, seven sites in Canada, recruiting 16 patients, five sites in Taiwan, recruiting 16 patients, and finally five sites in Japan, recruiting 11 patients. Two sites in the US have confirmed participation, expecting to activate and open on the current design by May 2020.

A planned amendment to the study will roll out in Q2 of 2020 which will see the study design change, to add in an additional therapy in combination to the existing regorafenib. This amendment will be commemorated with a name change, naming the new study as “INTEGRATE IIb”.

CLINICAL TRIALS: OESOPHAGEAL CANCER

James’ StoryFor James Watson, the annual charity trivia night at his workplace, Macquarie Bank, was more meaningful than it had ever been before. He had nominated the GI Cancer Institute as the charity for the group to support in memory of his brother Andrew, who passed away from oesophageal cancer earlier in the year.

His colleagues didn’t hesitate to help. The event was packed, with close to 300 people attending and 29 trivia teams taking part on the night. Members of the community donated prizes for a raffle and silent auction. A team of volunteers made up of James’s colleagues, worked through the night, collecting donations and ensuring that the event ran smoothly.

There was a spirit of generosity and community – the bar staff bought books of raffle tickets, and one attendee said that it was “a truly fabulous night – raising awareness and much-needed funds.”

Dr Lorraine Chantrill, a Director of the GI Cancer Institute, attended the trivia night and spoke about the importance of clinical trials in changing outcomes for gastro-intestinal cancer patients. James also spoke, thanking everyone for their support of clinical trials on behalf of himself and his family.

The trivia night raised over $80,000 for oesophageal cancer research and clinical trials – not only raising public awareness, but supporting research that can improve outcomes for patients in the future.

A G I T G

C L I N I C A L

T R I A L S

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Although stomach cancer is on the decline in Australia, it still affects a significant number of people. In 2011, 2,093 Australians were diagnosed with the disease and 1,143 people died in 2012. In 2019, the incidence of stomach cancer increased to 2,462; 1,287 people died in the same year.Open to recruitmentTOPGEARFor patients with stomach cancer, surgery may cure those with localised cancer, but most patients present with more advanced cancer. When treated with surgery, it will recur in 70% of patients.

Thus, surgery alone is not an adequate treatment. There are currently two ‘standard’ methods used worldwide to treat patients whose stomach cancer is more advanced: either treatment with chemotherapy before and after surgery, or a combination of radiation plus chemotherapy following surgery.

We believe that combining these two approaches will provide even greater benefit, especially if the combination of radiation plus chemotherapy is given prior to surgery.

This randomised controlled trial will build on previous research conducted and compare chemotherapy given before and after surgery, with or without adding concurrent chemotherapy and radiotherapy. The trial is being led by Australian investigators and includes participation by groups in Australia, Canada and Europe.

TOPGEAR is currently in phase III with 524 patients enrolled as of 31 December 2019 out of a target accrual of 620.

GIST In follow-upALT-GIST Gastro-intestinal stromal tumours (GIST) are rare cancers that can develop in different locations throughout the gastro-intestinal (GI) tract. When they have spread to other places (metastasised) or are not able to be surgically removed, they are not curable with any current treatment.

Medications have been developed that improve survival in patients with metastatic GIST. They work by blocking the signals that make these cells grow and spread. One of two drugs available on the Pharmaceutical Benefits Scheme in Australia, imatinib is used as the initial treatment for incurable GIST. Although many people with metastatic disease respond to imatinib initially, in almost all cases the cancer eventually becomes resistant to this drug and starts to grow. Until recently, a search for active new medicines in this setting had failed, but since then, regorafenib was shown to significantly delay progression in this setting. Regorafenib works in a similar way to imatinib although it targets a number of additional enzymes in tumour cells. This may explain its activity when imatinib is no longer active.

Recruitment of this trial closed in December 2017. There are 37 sites participating across Australia, Asia, Europe and Scandinavia with 78 patients recruited. The study is progressing in follow-up with 32 out of 78 patients still on treatment. The study follow-up will be ongoing until December 2020 for subsequent final evaluation in 2021.

NETs Open to recruitment NABNECThe aim of the study is to assess if a carboplatin and nab-paclitaxel chemotherapy combination is an

effective and tolerable treatment for advanced neuroendocrine carcinomas (NECs). The trial will also look at outcomes of survival, monitor the side effects of treatment, identify useful markers of prognosis and response, and increase our understanding of the biology of NECs.

NABNEC is funded by an NHMRC Project Grant from 2016-2020 and ethics approval was obtained in March 2016. Additional funding per patient and supply of nab-paclitaxel was provided by Specialised Therapeutics Australia and executed in August 2016.

Since the study opened in 2016, 36 patients have been recruited to the trial at 16 open sites. A poster was presented at the European Society for Medical Oncology meeting in 2017 and at the American Society for Clinical Oncology gastro-intestinal cancer meeting in 2018.

In follow-upCONTROL NETsThe aim of the study is to assess whether the combination of radiopeptide (PRRT) and chemotherapy is more effective than PRRT alone in mid-gut neuroendocrine tumours (NETs), and in pancreatic NETs the study compares PRRT and chemotherapy to chemotherapy alone. If the combination treatment demonstrates a more positive effect, this could then be further investigated in a larger phase III randomised trial, the results of which would guide best practice.

The study closed to recruitment in November 2018 after reaching its final target of 75 patients. CONTROL NETs has been supported by funds from the Unicorn Foundation, The University of Sydney and the Tour de Cure.

Presentation of primary results are planned for 2020 and follow up of patients is expected to continue until early 2022.

CLINICAL TRIALS: STOMACH CANCER, GIST & NETS

Jeanette's StoryJeanette Lau Gooey was diagnosed in 2013 with a gastro-intestinal stromal tumour (GIST). Since her diagnosis she has been under the care of Professor Lara Lipton.

Her treatment consisted of surgical operations to remove tumours and a drug called Glivec (imatinib). In July 2018, things took a turn for the worse. The drug that had kept her cancer under control ceased to be effective.

There were only two other drugs available to treat GIST. One by one, Jeanette was treated with these drugs. Within a space of five months both these drugs had failed to control her cancer and in the week before Christmas 2018, all treatment options available had been exhausted.

However, clinical trials for a new drug for treatment of GIST were underway. Professor Lipton was able to refer Jeanette to Professor John Zalcberg to obtain access to this trial drug. For the last 12 months Professor Zalcberg has been managing Jeanette’s treatment using the trial drug.

In 2019, while going through treatment for GIST, Jeanette committed to supporting Professor Lipton, who is training and fundraising for an ascent of Mt Himlung Himal in Nepal to raise funds for GI cancer research. Jeanette attended every fundraising event she could. She has written moving and thoughtful pieces about her experience attending these events, and their parallels with her cancer journey, for the GI Cancer Institute.

In one story, she says, “The fight to survive brings out strengths that you never knew you had. This may sound very strange but the cancer journey has made me a better person.”

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Pancreatic cancer is amongst the most lethal of all adult cancers and growing – 3,599 people were diagnosed with pancreatic cancer in 2019 and an estimated 3,051 people died from it in Australia in 2019. The five-year survival rate is just 9.8%.

Open to recruitmentDYNAMIC-Pancreas DYNAMIC-Pancreas is the first large scale randomised clinical trial investigating whether circulating tumour DNA (ctDNA) analysis can inform adjuvant chemotherapy in early-stage pancreatic cancer. Understanding how likely a cancer is to recur means we can make the best treatment decision for each patient. In the majority of cases, long-term survival can only be achieved with surgical resection of localised disease. Following resection, the routine use of adjuvant chemotherapy improves

survival outcomes. However, there are currently no biomarkers that define patients that are more or less likely to benefit from treatment, or whether patients should receive a combination of two or three chemotherapy drugs, or if there is any benefit from neoadjuvant therapy with surgery versus immediate resection and adjuvant therapy.

This study will enrol two participant cohorts: those receiving neoadjuvant therapy and those undergoing immediate resection followed by adjuvant therapy. ctDNA levels will be assessed prior to commencing adjuvant chemotherapy. Treatment will be risk-adapted for the investigational cohort based on the ctDNA results.

The aim of the DYNAMIC-Pancreas study is to demonstrate that a ctDNA-informed approach to chemotherapy, following surgery for localised pancreatic cancer, could lead to a reduction in the proportion of patients with detectable ctDNA

after completion of treatment compared to standard of care.

As of 31 December 2019, 15 sites had been activated and 11 patients had been recruited out of a target of 438.

MASTERPLANThis study aims to determine if adding stereotactic body radiotherapy (SBRT) to modern chemotherapy (mFOLFIRINOX or gemcitabine with nab-paclitaxel) for patients with high-risk or unresectable (locally advanced) pancreatic cancer improves cancer control rates in and around the pancreas. A target of 120 patients will be recruited to determine if the cancer control rate (termed locoregional control) is considered superior with SBRT, compared to without.

Stereotactic body radiotherapy is the delivery of high doses of radiation to a tumour. Due to advances in technology, such as better imaging and better methods of radiation delivery, this treatment is now done

CLINICAL TRIALS: PANCREATIC, GALLBLADDER & BILIARY TRACT CANCER

for many tumour sites (lung, prostate, brain). In the setting of pancreatic cancer, SBRT has the advantage of being able to deliver radiation over a shorter period, two weeks rather than five weeks.

MASTERPLAN received grant funding from the Medical Research Future Fund in late 2018.

MASTERPLAN is being conducted in Australia and potentially expanding to New Zealand. There are currently 11 sites selected including 9 sites with ethics approval and 2 sites with TGA approval. Of these, 2 sites are open in Queensland and South Australia. Sites are currently screening for potential patients.

Cancer of the gallbladder and bile ducts is rare, with 965 people diagnosed in 2019 and 298 deaths in 2019. The five-year survival rate is only 20.1%.

Open to recruitmentACTICCA-1Cholangiocarcinoma is a type of cancer that develops in the bile ducts. Bile ducts are tubes that drain bile, a fluid produced in the liver, into the gut to help with the digestion of food. This type of cancer is rare, with only a few hundred cases in Australia every year. It occurs more often as people get older. There are still many unanswered questions about the best way to treat this cancer. If the cancer is only in the bile ducts, and has not spread to other parts of the body, the best treatment is to remove all the cancer with surgery.

Unfortunately, even though surgery is sometimes possible, the cancer can come back. For some other types of cancer, giving extra treatment with chemotherapy after surgery has been useful. However, there is no definitive trial evidence at the moment to show if this is true for cholangiocarcinoma. There is a need for a comparison

study to help improve the survival for people with this cancer.

This trial will help us to know if giving a chemotherapy combination of cisplatin and gemcitabine after surgery is better than standard of care treatment (capecitabine tablets) after surgery for cholangiocarcinoma in non-metastatic patients. It will monitor people to see how often their cancer comes back, and see if this happens less often when the combination chemotherapy is used. It will also monitor the side effects from the treatment, quality of life and complications from surgery, amongst other things.

This trial initially opened to recruitment in Australia in July 2016 and initially compared the combination of chemotherapy with cisplatin and gemcitabine after surgery to observation only after surgery. In 2017, results from another clinical trial demonstrated that treating patients with capecitabine delays recurrence of their cancer. This chemotherapy treatment has been adopted as standard of care since then. In May 2017, recruitment was temporarily halted and the ACTICCA-1 protocol was amended to include the new standard of care treatment for patients. The trial reopened to recruitment in November 2017.

As of 31 December 2019, 13 sites in Australia and New Zealand have opened, and 17 patients have been recruited.

A protocol amendment was submitted to ethics in December 2019 and we are awaiting their approval. The main change proposed to the protocol is the inclusion of chemoradiation sub-study as second randomization for R1 resected patients. The sub-study is optional for sites in Australia and New Zealand.

Tony, Mark, Frank & Daniel's StoryTony, Mark, Frank and Daniel all have one tragedy in common – each is the husband of a woman who lost her life to pancreatic cancer. This was not the first thing that brought them together – Frank and his wife Mee-Na knew Tony and his wife Lyn for over 20 years, and the couples played golf and travelled together. Fifteen years ago, when Mark began playing golf with Frank and Tony, he and his wife Caroline quickly became friends with the group.

Lyn first noticed something was wrong on an overseas trip with her grandchildren. Originally thinking that she had gallstones, tests revealed the worst – pancreatic cancer. When she was in hospital, she saw Caroline, and the two realised that they were being treated for the same disease.

Lyn passed away around 8 months after her diagnosis. On the day of her funeral, Mee-Na was admitted to hospital, also for pancreatic cancer.

When Daniel met Frank, Mark and Tony years later, he realised that their families’ experiences mirrored his. His wife Rochelle had also passed away from pancreatic cancer just a few months after a sudden diagnosis.

“The pancreatic cancer community needs to shout from the rooftops to make sure that people know that it’s a deadly cancer,” says Daniel. That’s why all four men joined together in 2019 to raise awareness of pancreatic cancer in the community. Their campaign took them to TV and radio on Channel 9, Sky News and the ABC, fighting for better treatments during November for Pancreatic Cancer Awareness Month.

Susan’s StorySusan Cross was always generous – to her friends, to the causes she supported, and to her two cattle dogs. As the executor of her Will remembers, her decision to leave a bequest to the GI Cancer Institute reflects her philanthropic nature, and her zest for life.

“She just had this gift of helping people, she was wonderful,” they say. “And a fantastic fundraiser. If she was in a charity or foundation, she was in there boots and all, raising money for them.”

Born in England, Susan trained and worked as an optometrist before moving to Australia with her husband to realise her dream of living on a farm. They bought a property in Yarrowitch and farmed cattle.

After many years, Susan and her husband went their separate ways and she moved to Laurieton, taking her horses and dogs with her. Her idyllic life near the coast was cut short when she was diagnosed with pancreatic cancer. Two years after her diagnosis, she would pass away.

“She was a lovely lady, she had a great zest for life and she was extremely successful at whatever venture she took on.”

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Colorectal cancer is cancer of the colon or rectum. It is also called bowel cancer and is the most common type of gastro-intestinal (GI) cancer. Australia has one of the highest rates of colorectal cancer in the world. In 2019, 16,398 people were diagnosed with colorectal cancer and 5,597 died in Australia. The five-year survival rate is now 69.9%.

Open to recruitmentASCOLT Aspirin is known to be helpful in preventing and treating heart and blood vessel diseases. There is growing evidence that aspirin also has some anticancer properties. Studies that have looked at large groups of patients with colorectal cancer suggest that aspirin might be able to reduce recurrence of the cancer and improve survival in patients with localised colorectal cancer. However, these findings need to be confirmed by information from randomised clinical trials before treatment with aspirin can be considered standard therapy for this group of patients.

Investigating the role of aspirin in colorectal cancer patients was chosen as the highest priority by Australian health consumers, clinicians and researchers at a national forum convened by the AGITG and University of Sydney in August 2011.The ASCOLT study will provide proof of the role of aspirin in patients with localised colorectal cancer and will set a new standard nationally and internationally. As aspirin is inexpensive, readily available and familiar to most people, any impact on increased survival is likely to result in it being widely used as a cost-effective agent.

ASCOLT is being conducted in 12 countries throughout Asia, Australia and New Zealand.

A successful Cancer Australia grant application was submitted in March 2016 and a second Cancer Australia grant was awarded in January 2017. AGITG will be the lead for overall translational activities in collaboration with the Walter and Eliza Hall Institute. As of 31 December 2019, the trial has recruited 398 patients with up to 36 sites in Australia and New Zealand.

ASCOLT Tele-Trial Rural patients experience difficulties in accessing clinical trials closer to home mainly because of the limited number of available clinical trial sites in rural and regional areas. Additionally, studies have shown that long-distance travel and expenses associated with travel are barriers to uptake of trials by rural and regional patients. Given that many cancer centres use teleoncology models to provide oncology services including chemotherapy services in rural areas, these models offer an opportunity to improve rural access to clinical trials.

One such model is a Tele-trial model. This model allows oncologists from established cancer centres to establish consent, recruit and manage patients on trials in rural and regional towns. The ASCOLT study will be run as a tele-trial with Orange Hospital as primary site and Dubbo Hospital as secondary site.

DYNAMIC-IIIThe aim of this study is to compare treatment informed by circulating tumour DNA (ctDNA) results to standard care in patients with stage III colon cancer.

Currently, the standard treatment for stage III colon cancer is surgical removal of the tumour followed by three to six months of chemotherapy. Chemotherapy is given as a combination treatment made up of two drugs including oxaliplatin or as a single drug treatment with fluoropyrimidine. Although studies have shown that chemotherapy reduces the risk of the cancer returning, not all patients benefit from treatment. For some, the cancer is cured by surgery alone, and others will experience cancer relapse even with treatment. It is difficult to adequately measure risk and treatment effectiveness for all patients.

The use of a biomarker that can better define the risk of the bowel cancer returning could make a major impact on treatment decisions for patients with stage III colon cancer. Circulating tumour DNA (ctDNA) may act as one such biomarker. For some people, cancer DNA can be found circulating in the bloodstream after the surgery to remove their bowel cancer, which provides evidence that some cancer cells have escaped and travelled to other parts of the body.

A previous study in patients with bowel cancer has shown that people with ctDNA detected in their blood after surgery have a very high chance of the cancer coming back compared to those with no ctDNA. Therefore, this study is trying to see if a chemotherapy decision based on the presence or absence of ctDNA after surgery will be more effective at determining the optimal type and duration of chemotherapy treatment that a patient will need after surgery.

As of 31 December 2019, 35 sites have been activated and 308 patients have been recruited out of a target of 1,000.

DYNAMIC-RectalColorectal cancer remains a major health burden in Western countries and is rapidly increasing in incidence in other countries where Western lifestyles are being adopted. Approximately 30% of colorectal cancers arise within the rectum, where preoperative chemoradiation and then surgery is standard for patients with locally advanced rectal cancer (LARC). While multiple advances have been made in managing rectal cancer, patient selection for adjuvant chemotherapy after surgery, and agent choice remain major clinical dilemmas.

Initial studies have demonstrated the potential utility of ctDNA as a marker of recurrence risk. The end goal for LARC patients is to integrate ctDNA analysis into routine clinical practice to guide treatment decisions and, most importantly, benefit patients. However, this will demand multiple studies, each building upon previous clinical trials toward the ultimate aim of improving patient survival. This initial study has been designed to determine whether a ctDNA-based approach to adjuvant therapy will lead to substantially less patients receiving adjuvant therapy.

DYNAMIC-Rectal opened to recruitment in July 2018. As of 31 December 2019, 26 sites have been activated and 99 patients have been recruited out of a target of 408.

MODULATEColorectal cancer is the most commonly diagnosed cancer in the Australian population. Surgery, with or without chemotherapy and radiotherapy, can be used to cure colorectal cancer that is diagnosed early. However, cases of advanced colorectal cancer where it has spread to other organs usually cannot be cured. Advanced colorectal cancer is treated with

chemotherapy and other drugs, known as targeted therapies. This can control advanced colorectal cancer for a limited time, but inevitably these cancers will evolve to become resistant to all the standard treatments available. By the time cancers progress to this stage, survival is poor and patients are increasingly symptomatic. Additional therapies are therefore needed to further extend survival of patients with advanced colorectal cancer.

This study aims to test whether it is possible to reverse the resistance of MSS colorectal cancer, a highly mutated form of colorectal tumour, to PD1 inhibition by combining the PD1 inhibitor nivolumab with other drugs designed to stimulate lymphocyte infiltration of tumours. Two approaches will be tested: an inhibitor of the signalling protein STAT3, and a vascular disrupting agent which blocks the blood supply of cancers. Pre-clinical laboratory studies suggest that targeting STAT3 or using vascular disrupting agents will improve lymphocyte infiltration into cancers, but this has not been proven in human studies.

MODULATE opened in September 2018. As of 31 December 2019, 15 sites have been activated and 80 patients have been recruited out of a target of 90.

MONARCCThe aim of this study is to investigate the activity of treatment with the anti-EGFR therapy panitumumab alone and panitumumab combined with 5-fluorouracil chemotherapy, in a molecularly selected, elderly patient population with metastatic colorectal cancer.

Metastatic colorectal cancer is a disease of the elderly. Anti-EGFR antibodies have not

been well studied in an elderly patient population, a group typically unsuited to combination chemotherapy. The median age in trials involving these agents is 60-65 years. As a result, there is an opportunity to investigate the activity of anti-EGFR monotherapy, or combined with “light” chemotherapy in a molecularly selected, hitherto under-investigated but prevalent patient population.

Recruitment for patients opened in 2018. As of 31 December 2019, 18 sites have been opened and 14 patients have been recruited out of a target of 80. A poster was presented at the American Society for Clinical Oncology gastro-intestinal cancer meeting in 2020.

SPAR This randomised phase II trial aims to evaluate the effect of simvastatin on efficacy and toxicity of pre-operative chemoradiotherapy in rectal cancer patients, and on systemic and local inflammatory responses. Rectal cancer is often treated by chemotherapy and radiation before surgery, but if the cancer responds poorly to this treatment many patients relapse. Retrospective studies show better cancer responses and fewer side effects in patients taking a statin drug (for cholesterol) during radiation therapy. This study aims to recruit 222 patients from hospitals in Australia and New Zealand to test if taking a statin for three months (during combined chemotherapy and radiation then for another six weeks) improves the rate of good tumour response and reduces side effects of this treatment.

Recruitment for patients opened in April 2018. As of 31 December 2019, 11 sites in Australia and New Zealand are open to recruitment and 37 patients have been recruited.

CLINICAL TRIALS: COLORECTAL & ANAL CANCER

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In 2019, the AGITG launched the Endorsed Study Model. Investigators are encouraged to submit concepts for trials that will be sponsored by other organisations for AGITG endorsement.

This means that AGITG can liaise with the sponsoring institution to:• Conduct feasibility to gauge interest

from a wide network of potential sites to participate in the study;

• Advertise the study on the AGITG website;

• Invite presentations at the ASM; and

• Provide CAP review and feedback of key documents.

There are three endorsed studies currently open to recruitment:

PALEO: Oesophageal cancerThe purpose of this study is to investigate the effects of the addition of stereotactic body radiotherapy (SBRT) to treatment with nivolumab in people with oesophageal cancer that has spread to another area of the body.

Nivolumab is an antibody (a type of human protein) that works by blocking a body substance called PD-1. Blocking PD-1 helps the body’s immune system ‘switch on’ to attack cancer cells. Other clinical trials have shown that nivolumab can slow tumour growth and shrink tumours in some patients with oesophageal cancer.

Stereotactic body radiotherapy is a form of cancer treatment involving high precision radiotherapy. Standard radiotherapy treatment is usually delivered in small doses over many treatments (usually five to 30 treatments). SBRT treatment is different as it uses a higher dose of radiation delivered in one to three treatments. SBRT treatment has been used successfully in multiple tumour sites in the body, including the lung, liver, bones and lymph nodes. It is

believed that giving both nivolumab and SBRT will increase the ability of the body’s immune system to attack cancer cells.

PALEO opened to recruitment on 16 September 2019, and one patient has been enrolled in the study so far.

Neo-CREATE: Gastro-oesophageal cancerGastro-oesophageal cancers are a significant global health burden, representing the 8th most commonly diagnosed cancers. The incidence rates of distal oesophageal and gastro-oesophageal junction cancers are rising in Western countries. In patients with early-stage resectable, disease the prognosis has been guarded with a 5-year survival rate of 33% after surgery alone. Survival advantage has been demonstrated in clinical trials with neo-adjuvant chemoradiotherapy or perioperative platinum based chemotherapy. The potential benefits of neo-adjuvant CRT mainly are down-staging, facilitating R0 resection and treatment of micro-metastases to reduce risk of local and systemic recurrences.

The purpose of Neo-CREATE is to assess the safety of adding the drug avelumab to chemoradiation using two standard chemotherapy drugs, carboplatin and paclitaxel, before surgery in patients with cancers of the oesophagus or the junction between the oesophagus and stomach (gastro-oesophageal junction). The medications used in this study are given intravenously (by vein).

Avelumab is thought to work by helping the immune system to fight against cancer cells. The purpose of this study is to determine if adding avelumab to the chemotherapy and radiotherapy will be better. According to current standard of care chemoradiation is given before surgery (preoperative treatment), avelumab will be given at the same time. The main aim of this study is to determine if adding avelumab to preoperative chemoradiation

is tolerable and more effective than preoperative chemoradiation alone for patients with localised oesophageal and gastro-oesophageal junction cancer who are going to be treated with surgery. We will also be looking at the adverse events of this combination treatment.

Neo-CREATE opened on 17 June 2019, and three patients have been enrolled in the study.

RENO: Rectal cancerRENO is a prospective study of ‘watch and wait’ strategy in patients with rectal cancer who have developed a clinical complete response with concurrent chemoradiotherapy.

Rectal cancer is a common malignancy and comprises a third of the cases of colorectal cancer. Currently, a combination of chemotherapy plus radiotherapy followed by surgical resection of the rectum is the standard management of locally advanced rectal cancer. Approximately 20% of patients develop a pathological complete response to chemoradiation. In these patients, surgery may not be necessary. There are retrospective studies showing the safety of a 'watch and wait' strategy instead of surgery in patients who do not have any signs of disease after completing chemoradiation. This approach may save the patient from surgical risks and long-term morbidity.

With this study, the aim will be to assess the safety of the ‘watch and wait’ approach in this population and prove the feasibility of a structured follow-up program. The study will also assess novel biomarkers, patient-reported outcome measures and health economics, none of which have been studied in this population.

This trial opened in 2019 and 12 patients have been enrolled in the study.

Pictured: Professor Chris Karapetis

ENDORSED STUDIES

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Many participants in AGITG trials choose to donate their tissue and blood samples for research. Thirty-eight AGITG trials currently collect or have collected tissue and blood from participants.

These samples, called biospecimens, are used in translational research studies. This research seeks to discover biomarkers, biological flags that may help to select patients who are most likely to benefit from a treatment or spare particular patients from treatment toxicities.

Work continues with our local and international research collaborators on many of these translational research studies. Over 80% of trials in the AGITG portfolio have confirmed proposals using biospecimens.

The science of these translational research proposals are reviewed by the trial management committees, the Upper & Lower GI Working Parties and the Scientific Advisory Committee.

The joint AGITG and the Canadian Clinical Trials Group (CCTG) Correlative Research Committee also review translational research proposals relating to three colorectal cancer trials (CO.17, CO.20 and CO.23). There are currently 19 translational research studies underway using biospecimens from these trials.

2019 highlights include:• The MASTERPLAN trial in pancreatic

cancer (mFOLFIRINOX and stereotactic body radiotherapy) opened. Participants will donate blood and tissue samples for research. If the participant agrees, tissue samples may be obtained from them at several different times during their treatment.

• A trial in a type of colon cancer called POLEM(dMMR or POLE exonuclease domain mutant), was awarded a Medical Research Future Fund grant for International Clinical Trials. Participants may choose to donate faecal samples for the study of their microbiome – the microorganisms in the gut.

• A trial in colon cancer (dMMR or POLE exonuclease domain mutant) called POLEM, was awarded a Medical Research Future Fund (MRFF) grant for International Clinical Trials. Participants may choose to donate faecal samples for the study of their microbiome – the microorganisms in the gut.

Our trials are using a range of technologies to analyse patient samples, for example: - A platform for the large-scale

analysis of gene expression (RNA from tissue samples) is being used in the GAP (pancreatic cancer) and CO.23 (colorectal cancer) trials;

- Circulating tumour cells sloughed off from the primary solid tumour are being isolated from patient blood for further study in the NABNEC trial (neuroendocrine tumours); and

- Proteomics is being used to analyse large numbers of blood proteins in two trials: GAP (pancreatic cancer) and INTEGRATE (gastro-oesophageal cancer).

TRANSLATIONAL RESEARCH

Jim's StoryJim Kershaw started to feel unwell in 2001. He ignored telling anyone about the symptoms for as long as he could, especially his wife Carol – he didn’t want her to worry.

Eventually he had a colonoscopy. It confirmed the worst. Jim had colon cancer. “You think your world’s come to an end,” says Jim. “You just think it’s all over. You don’t know the result, what’s going to happen.”

Jim had surgery to remove his tumour, followed by six months of chemotherapy. The side effects were harsh but at first the treatment seemed to have worked.

In 2003, however, doctors discovered the cancer had spread to his liver. Then Jim’s oncologist, Professor Desmond Yip, recommended him for a clinical trial. “It kind of blew me away,” Jim says. “It felt like I’d won. Doctors were telling me there’s hope.”

The trial gave him access to new treatments that fought the spread of the cancer to his liver. “He used to say to me that every time he got an ache or a pain, he would think, “I wonder is the cancer back?” says Carol. “You just live from one day to the next.”

Jim has now been living with cancer for almost 18 years. Cancer has not taken his mobility – he still works, and he and Carol spend as much time as possible with their family. They see their grandchildren every day, and Jim takes his grandson to football training every Saturday. “He keeps us going, keeps me going,” says Jim.

“Blood testing through ‘liquid biopsy’ technology could be a better way of screening patients. Some methods have pros and cons, some are more sensitive than others, and some are more expensive than others, so in the LIBERATE study we’re testing a few different techniques to try and determine which is the best method.”

Professor Niall TebbuttPrincipal Investigator, LIBERATE

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NHMRC Clinical Trials CentreThe NHMRC Clinical Trials Centre (CTC) is a leader in clinical trials. Through excellence in research and trials, we improve practices, policy and health outcomes for patients globally.

Since the CTC's establishment in 1988, we have worked with our partners to contribute major advances in clinical care. This includes running over 200 clinical trials involving more than 80,000 patients and 800 international collaborators.

We service the full clinical trial spectrum — from assisting in establishing new groups by creating a research governance structure and terms of reference, identifying important questions related to public health, and concept and protocol development, through to randomisation, data collection, ethics and regulatory compliance, on-site monitoring and audit, and data analyses and manuscript preparation.

The CTC works collaboratively to design and run trials with five of the 13 national cancer cooperative groups in Australia. We have helped recruit thousands of patients locally and globally in breast, oesophageal, gastric, colorectal, lung, gynaecological, neurological and urogenital cancers.

The CTC has collaborated with the AGITG since 1991, conducting 57 trials involving over 5,000 patients around the world. Together, our research has changed treatment practices for patients with gastro-intestinal tumours, improving life expectancy and quality of life.

Walter & Eliza Hall Institute of Medical ResearchMelbourne’s Walter and Eliza Hall Institute is one of Australia’s leading biomedical research organisations, with a strong national and international reputation for performing highly influential basic and translational research.

With more than 1,100 staff and students, the Institute is addressing some of the major health challenges of our time, with a focus on cancer, infection, inflammation, immune disorders, development and ageing. The Institute is at the forefront of research innovation, with a strong commitment to excellence and investment in research computing, advanced technologies and developing new medicines and diagnostics.

The Institute is organised around five themes; Cancer Research and Treatments; Infection, Inflammation and Immunity; Healthy Development and Ageing; New Medicines and Advanced Technologies and Computational Biology.

This Institute is committed to delivering long term improvements in treating and diagnosing diseases, with many national and international clinical trials underway based on research undertaken at the Institute. Around 50 medically trained researchers are embedded within the Institute’s multidisciplinary research teams, and the Institute maintains strong links with clinical partners, including through the Victorian Comprehensive Cancer Centre and the Australasian Gastro-Intestinal Trials Group.

The Centre for Biostatistics and Clinical Trials (BaCT)The Centre for Biostatistics and Clinical Trials (BaCT) at Peter MacCallum Cancer Centre provides a full range of service to clinical trials to facilitate the advancement of treatments and improved outcomes for cancer patients. In operation for over 40 years, we are committed to excellence, innovation and adaptability. BaCT uses the latest technologies to ensure efficient and timely clinical trial oversight and data capture, and provides expert statistical support.

BaCT staff can be involved at all phases of study, from collaboration on protocols and trial design from clinical, regulatory and statistical perspectives, to Trial Master File preparation and management, safety

AGITG ENGAGED COORDINATING CENTRES

reporting management, eCRF design and development, and interim and final statistical analyses, among other tasks. The team implements high-quality biostatistics, clinical, data management, quality assurance, pharmacovigilance and trial centre project management services to a diverse research community.

BaCT is delighted to work with the AGITG on the experimental Phase II MODULATE trial. This trial studies two different combinations of immunotherapy treatments for colorectal cancer.

Survivorship Research Group (SuRG)SuRG is part of the Centre for Medical Psychology & Evidence-based Decision-Making (CeMPED), a cross-school, faculty and discipline research group at the University of Sydney.

We have a small, efficient team of four research officers, eight PhD students, and one post-doctoral research fellow, located across our Camperdown and Concord Campuses, who are engaged in research projects related to cancer survivorship and the cancer experience. CeMPED’s mission to conduct excellent research across the interface of Psychology, Medicine, and Public Health to answer questions about: the behavioural factors which promote good health and prevent disease; ways to enhance the psychosocial adjustment of patients and carers; ways to increase use of evidence in health care decision making and ways to support patients to be more involved in their own health care. Our own work address these issues within the cancer context. Our team has particular expertise in cancer

and cognition having conducted a large international cohort study of Cancer and Cognitive Function in colorectal cancer patients.

We are the Australian Coordinating Centre for the Co.21 CHALLENGE trial of a 3-yr lifestyle intervention in colon cancer survivors. We are excited to be coordinating the OXTOX study, evaluating the efficacy and safety of ibudilast on peripheral neuropathy symptoms in patients receiving oxaliplatin. This is work stemming from our collaboration with laboratory-based researchers in the School of Psychology, University of Sydney and builds on the Phase I study of Dr Christina Teng, Medical Oncologist and PhD Candidate.

The AGITG collaborates with coordinating centres across Australia to conduct our clinical trials. The staff at these centres work with the AGITG to oversee the operations of our trials from development to completion.

Chris's StoryIn October 2018, 46-year-old Chris Schwarzer was doing his best to ignore how unwell he felt as he threw himself into his job as a civil engineer on a major infrastructure project. When he looked in the bathroom mirror at work and saw a yellow, jaundiced face looking back at him, he knew something was wrong.

So did his GP, who sent him straight to hospital. It was the middle of the night when he received the news that completely shattered his life: Chris’s tests showed he had pancreatic cancer.

“I was so scared,” says Chris. “The only thing I had going for me was that my tumour was small and it was discovered early.”

Like most healthy people, Chris had never really thought about serious illness, working hard through the week, and coaching his daughter’s soccer team on the weekend.

He was facing the very real possibility that he might not see his children grow up.

Major surgery removed the tumour and then Chris started chemotherapy treatment. Through everything, Chris’s priority was to shield his kids from what he was going through.

“I’d use all my mental power to get up when they came home from school. Say hello, just be nice,” he says.

Chris’s wife Annabel was a source of “amazing support” and together they were determined not to give in to despair.

Today, Chris is slowly recovering from his ordeal. He walks around the block. He’s started going back to watch his kids play soccer. Most of all, he tries to make the most of every precious day with his family.

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Journal publications and conference presentations provide clinicians and patients with the most up-to-date treatment results.

In 2019, the AGITG published clinical trial results in leading international medical journals. The five publications and five presentations included trials in advanced gastric cancer, gastro-intestinal stromal tumours (GIST) and locally advanced rectal and pancreatic cancer.

Publications ALaCaRTStevenson A, Solomon M, Brown C, Lumley J, Hewett P, Clouston A, Gebski V, Wilson K, Hague W, Simes J. Disease-free Survival and Local Recurrence After a ‘Laparoscopic-Assisted’ Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomised Clinical Trial. Ann Surgery, 2019.

INTEGRATE IIChua YJ, Pavlakis N, Sjoquist K, Martin AJ, Tsobanis E, Yip S, Bang Y-J, Alcindor T, O’callaghan CJ, Bekaii-Saab TS, Grothey A, Chen L-T, Simes J, Zalcberg JR, Goldstein D, Komatsu Y, Machida N, Esaki T, Hara H, Shitara K. Randomised Phase III Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC) - INTEGRATE II. Ann Oncology, 2019.

MASTERPLANOar A, Lee M, Le H, Hruby G, Dalfsen R, Pryor D, Lee D, Chu J, Holloway L, Briggs A, Barbour A, Chander S, Ng SP, Samra J, Shakeshaft J, Goldstein D, Nguyen N, Goodman KA, Chang DT, Kneebone A. Australasian Gastrointestinal Trials Group (AGITG) and Trans-Tasman Radiation Oncology Group (TROG) Guidelines for Pancreatic Stereotactic Body Radiation Therapy (SBRT). Pract Radi Oncol, 2019.

MAXRico GT, Price T, Tebbutt N, Rico GT, Price T, Tebbutt N, Hardingham J, Lee C, Buizen L, Wilson K, Gebski V, Townsend A. Right or left primary site of colorectal cancer: outcomes from the molecular analysis of the AGITG MAX trial. Clinical Colorectal Cancer, 2019.

SPARJameson MB, Gormly K, Espinoza D, Hague W, Asghari G, Jeffery GM, Price TJ, Karapetis CS, Arendse M, Armstrong J, Childs J, Frizelle FA, Ngan S, Stevenson A, Oostendorp M, Ackland SP. SPAR - a randomised, placebo-controlled phase II trial of simvastatin in addition to standard chemotherapy and radiation in preoperative treatment for rectal cancer: an AGITG clinical trial. BMC Cancer.

PresentationsALT-GISTYip D. Clinical activity of avapritinib in ≥ fourth-line (4L+) and PDGFRA Exon 18 gastro-intestinal stromal tumors (GIST). American Society of Clinical Oncology (ASCO) Annual Meeting, 1-4 June 2019, USA.

INTEGRATE IIChua Y, Pavlakis N, Sjoquist K, Martin A, Tsobanis E, Yip S, Bang Y, Alcindor T, O'Callaghan C, Bekaii-Saab T, Grothey A, Chen L, Simes J, Zalcberg J, Goldstein D, Komatsu Y, Machida N, Esaki T, Hara H, Shitara K. INTERGRATE II: A randomised phase 3 double-blind placebo-controlled study of regorafenib in refractory advanced gastro-oesophageal cancer. Japanese Society of Medical Oncology (JSMO) July 2019, Japan.

TOPGEARMichael M, Lordick F, Smithers B, Zalcberg J, Simes J, Findlay M, Gebski V, O’Connell R, Miller D, Aiken C, York S, Wong R, Haustermans K, Swallow C, Darling G, Strickland A, Lee M,

Ringash J, Thomas M, Leong T. TOPGEAR - a phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer: Comparison of FLOT versus ECX/F. International Gastric Cancer Congress (IGCC) 2019, May 2019; Czech Republic.

Leong T, Pre/Peri- vs Post-operative radiation strategies for localised Gastric Cancer. International Gastric Cancer Congress (IGCC), May 2019; Czech Republic.

Leong T, Perioperative Therapies for Gastric Cancer: Neoadjuvant Strategies and Indications. American Society of Clinical Oncology (ASCO) GI Cancers Symposium, January 2019, USA.

JOURNAL PUBLICATIONS & CONFERENCE PRESENTATIONS

Pictured: Professor Trevor Leong

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AWARDWINNER

AGITG

2019

“I was thrilled to receive the Innovation Fund grant to conduct the FORECAST-1 study. This grant will enable us to test a new development in personalised bowel cancer treatment that could give hope to people who have no other options.”

Professor Peter Gibbs Innovation Fund Grant

Step �. Identify a gap in researchAs a medical oncologist, Professor Peter Gibbs regularly sees patients with bowel cancer who have completed standard treatments but are not cured of their cancer. This is a large population of patients who need treatments.

Professor Gibbs noted that there are a number of drugs that had been tested for colorectal cancer that showed some promise, but not in a high enough proportion of patients to be taken through to the definitive phase III study. These have been shown a response in a subset of patients, around 10-30%. This means that these drugs are not effective for all patients, but for a select group of patients they could be very promising.

Step 2. Identify a new technology with research potentialThe development of a new technology, organoids, sparked Professor Gibbs’ idea for a trial. Organoids are miniature tumours grown in a lab from samples taken from patients. These miniature cancers can be treated with cancer drugs in the laboratory. The way the organoids behave in the lab predicts how the same response might work in patients.

Step 3. Conduct pre-clinical research and retrospective studiesProfessor Gibbs examined previous biopsies (samples) that had been taken from patients with colorectal cancer.

These samples were taken from an unselected population of patients who were having a biopsy for another reason or having a tumour removed that an organoid could be cultured from. Researchers collected data on these patients and the therapy they had been treated with, and tested if the therapy response of the patient correlated with the way the organoid was treated.

Once this retrospective data was collected and analysed, it was time to create a prospective study – a much stronger step in terms of validating this treatment model.

Step 4. A research team is assembledThis trial presents an opportunity for scientists and clinicians to collaborate in a joint project. Professor Gibbs assembled a team including scientists to culture the organoids and test the drugs, and clinicians who treat patients directly.

Step 5. Application to the AGITG Innovation FundProfessor Peter Gibbs prepared a grant application for the 2019 AGITG Innovation Fund and was awarded a $200,000 grant. His study is titled FORECAST-1, and he hopes it will provide a personalised treatment approach for colorectal cancer patients.

Step 6. Apply to the AGITG Innovation FundFORECAST-1 will open at six hospitals in Melbourne in 2020 that will be enrolling patients. It will be the first trial of its type in the world to run in this particular model. If the results are positive, larger studies can be conducted to determine whether this treatment model can be implemented into clinical practice more broadly.

To successfully obtain funding for academic research and to establish a clinical trial takes a considerable amount of effort, time and collaboration across multi-disciplinary teams.

GENESIS OF A CLINICAL TRIAL: FORECAST-1

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The meeting focused on challenging the enigmatic nature of gastro-intestinal cancers, and the program’s presenters discussed the common difficulties faced in this group of cancers as well as innovative approaches to treatment.

The Meeting Convenor, Dr Lorraine Chantrill, Head of Medical Oncology at Illawarra Cancer Care Centre at Wollongong Hospital, noted, “This meeting is a unique and valuable opportunity for clinicians and researchers working in the field of gastro-intestinal cancers to share experiences and insights. Through this networking and collaboration we can generate better treatments for these cancers.”

A full day was dedicated to Trainee and Study Coordinator Workshops the day before the ASM. The workshops provided a compelling education program for each discipline.

Statistician Rebecca Asher spoke about the ‘role of statistics in producing a well-designed trial with high quality results’, specifically statistical concepts for consideration in trial development and reporting of results. Flynn Slattery’s guide to creating an effective scientific poster and Professor Chris Karapetis’ Protocol Writing session were also popular practical workshops. Finally, Dr Amitesh Roy, Dr Chantrill and Professor David Watson presented on key issues and challenges in designing and conducting clinical

trials in the changing landscape of GI cancer research.

Clinical research consultant Tanya Symons gave the first presentation of the Study Coordinator Workshop, on important Good Clinical Practice (GCP) topics such as safety reporting, serious breach of GCP/protocol and risk-based monitoring. Dr Matthew Burge followed with an update on current treatment and biomarkers that influence clinical practice. Professor Nik Zeps and Professor John Simes ended the session with challenges of current site governance mechanisms and translating research into practice.

The AGITG Consumer Advisory Panel’s second meeting of the year was held concurrently to these workshops. The workshops and meeting were followed by a tour of the state-of-the-art South Australian Health and Medical Research Institute, as well as a lecture on Translational Research 101 presented by Dr Susan Woods and Associate Professor Dan Worthley.

The ASM began with the Keynote Breakfast Session, where Professor Sharlene Gill presented,

‘Colorectal cancer is one disease but with many faces’; a review of the evidence supporting current and future biomarkers for metastatic colorectal cancer and opportunities for molecular stratification, that may inform clinical trial design, as well as potential predictive biomarkers for immunotherapy in this disease area.

All eyes were on rare and underfunded cancers and cancer subtypes at the 21st Annual Scientific Meeting (ASM).

We were honoured to host Australian and International experts to present at the ASM, including:

Professor James L. AbbruzzeseMedical Oncologist Duke Cancer Institute, USA

Professor Sharlene GillMedical Oncologist BC Cancer, Canada

Professor Christian JobinImmunologist/Microbiologist The University of Florida, USA

Professor Florian LordickMedical Oncologist University Hospital Leipzig, Germany

Associate Professor Manisha Palta Radiation Oncologist Duke University School of Medicine, USA

Professor Stephen J. WigmoreSurgeon Royal Infirmary of Edinburgh, UK

Ms Kate FurnessClinical Dietitian Monash Medical Centre, VIC

Associate Professor Eddie LauRadiologist & Nuclear Medicine Specialist Austin Health, VIC

Professor Emad El-OmarGastroenterologist St George Hospital, NSW

Professor Peter GibbsMedical Oncologist Walter and Eliza Hall Institute of Medical Research, VIC

Ms Tanya SymonsClinical Research Consultant Symons Associates, NSW

AGITG ANNUAL SCIENTIFIC MEETING

A N N U A L

S C I E N T I F I C

M E E T I N G

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At the Opening Plenary, ‘Rare cancers: How can we do better?’ Professor Christian Jobin spoke about the predictive power of microbiota, ecological communities of commensal, symbiotic and pathogenic microorganisms. There is some evidence that the tumour microbiome can predict pancreatic cancer patients’ outcomes, and that microbiota diversity could have an impact on treatment for some cancers. Professor Stephen J. Wigmore spoke about state of the art treatment for biliary cancers, outlining the effectiveness of current surgical approaches and therapies, and research into novel drug targets. Finally, Associate Professor Manisha Palta gave a presentation on the combination of radiation and immunotherapy, weighing up toxicity and benefit.

In the afternoon, the Multidisciplinary Workshop provided an opportunity for delegates

to delve into controversies in pancreatic cancer. Professor James L. Abbruzzese opened by speaking about the state of the art management of operable pancreatic tumours. Professor Stephen J. Wigmore and Associate Professor Manisha Palta presented fascinating arguments on the pros and cons of primary surgery versus neoadjuvant therapy. Ms Kate Furness spoke about the effect of early and intensive nutrition care on quality of life for people with upper GI cancers.

The next day began with Associate Professor Manisha Palta’s fascinating presentation on treating oligometastatic disease with stereotactic body radiotherapy (SBRT). She spoke about the benefits of ablative radiotherapy and noted that higher doses seemed to be more effective.

This was followed by the

Translational Science Symposium, where six experts presented updates on cutting-edge translational science in GI cancer, specifically the microbiome and their ability to influence tumour growth, responses to cytotoxic drugs and immunotherapeutics. Professor Jobin discussed how programmable bacteria may cause tumour regression, and Professor Emad El-Omar spoke about how outcomes for upper GI cancers could be affected by changes in the microbiome.

Other highlights of the Translational Science Symposium included Associate Professor Tarik Sammour's discussion of research regarding total neoadjuvant therapy (TNT) followed by surgery for rectal cancer, which improves pathological complete response (PCR) and disease-free survival (DFS). The topic of pooled data analyses was covered by Professor Michael Sorich, providing interesting insights into

how secondary data can be acquired from existing trials but could involve time consuming data preparation. Professor John Mariadason discussed different mutations found in biliary tract cancers (including IDH, ERBB, FGFR and MEK mutations) highlighting mixed data when drugs were given against these oncogenes.

The Radiation Oncology Workshop on Thursday was focused on anal cancer treatment. Associate Professor Eddie Lau discussed response assessment using PET scans and the role of interim PET, and Associate Professor Palta delved into new approaches like the role of dose escalation and individualised radiotherapy for this disease.

At the Joint Consumer / Study Coordinator Forum, a range of topics were discussed, including the importance of quality of life and survivorship research led

by Dr Claudia Rutherford, and Associate Professor Haryana Dhillon's discussion of how exercise can affect outcomes for patients. Consumer Advisory Panel member Grant Baker gave insight into the challenges of patient compliance through the lens of his own experience.

One highlight of the ASM each year is the New Concepts Symposium, sponsored by Specialised Therapeutics. Four new research concepts were presented with feedback from the International Faculty. The Best New Concept Award was presented to Dr Mark McGregor for ‘A phase II study of oncolytic immunotherapy of metastatic neuroendocrine tumours using intralesional rose bengal disodium in combination with pembrolizumab’.

At the Poster & Fast Forward Session, sponsored by GenesisCare, the

Best Poster Award was awarded to Dr Swetha Sridharan for ‘Palliative Oesophageal Chemoradiotherapy: A Phase I Clinical Trial’. Next was the Fast Forward Session, where delegates had just three minutes to present their concepts. Dr Simon Wilkins was awarded the Best Fast Forward Award for ‘The effect of oversewing double stapled anastomoses in oncological colorectal surgery’.

At the 21st Annual Meeting Dinner on Thursday night, the AGITG Innovation Fund was awarded to Professor Peter Gibbs for his innovative study testing the sensitivity of different therapies for patients with advanced colorectal cancer using organoids grown in the lab.

AGITG ANNUAL SCIENTIFIC MEETING 2019

Pictured (L-R): The ASM Multidisciplinary Panel, Tour of the South Australian Health and Medical Research Institute

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Platinum Sponsor

Gold Sponsors

Silver Sponsors

Bronze Sponsors

“I am thrilled that we have received the Innovation Fund grant to conduct such an important study,” says Professor Gibbs. “This grant will enable us to test a new development in personalised bowel cancer treatment that could give hope to people who have no other options.”

Professor Val Gebski was recognised for his outstanding contribution to the AGITG with the John Zalcberg OAM Award for Excellence in AGITG Research.

“It is an honour to receive the John Zalcberg OAM Award,” Professor Gebski said. “I am proud to have contributed to research which has resulted in improvements in gastro-intestinal cancer treatment, and to have contributed to the design of high quality clinical trials resulting in international recognition of the excellence of AGITG.”

The Merck-AGITG Kristian Anderson

Award was presented to Dr Ryan Cohen. Dr Cohen will complete his PhD at the University of Western Australia. Professor Niall Tebbutt received the inaugural AGITG Member Fundraiser of the Year Award in recognition of his commitment to fundraising for GI cancer research, and Calvary Mater Newcastle received the AGITG Outstanding Site Award for its commitment to AGITG clinical trials.

Friday began with the meeting’s final Keynote Breakfast Session presented by Professor Abbruzzese, who discussed translating treatment of pancreatic cancer into survival benefits, including emerging areas of research such as the microenvironment and the disruptive nature of precision medicine.

Finally, Professor Tim Price and Professor Stephen Ackland chaired

the Closing Plenary entitled ‘Trials and tribulations in colorectal cancer in 2019’. Professor Simes, the 2018 recipient of the John Zalcberg OAM Award for Excellence in AGITG Research, presented on the importance of clinical trials. He noted the benefit to cost ratio of clinical trials, and that well conducted randomised trials are still needed to inform best practice. Innovation Fund recipient Professor Gibbs discussed registry trials, stating that in improving registry-based research it was key to have bigger numbers, better quality, and broader scope.

It was then time to hear insights from the Invited Faculty. Professor Jobin addressed the tremendous clinical translational potential of microbiomes in cancer. Microbiota is an integral component of the host, and there is a link between diet, microbiota and inflammation. Finally, Professor Florian Lordick

discussed recent advances and perspectives of stage IV colorectal cancer, including deficient mismatch repair, BRAF mutated, KRAS mutated and HER2 amplified tumours, as well as gene fusion. He stressed the role of doctors as guides and partners of patients over a long period of time.

AGITG trials were also presented in updates across the three days:

Colorectal and anal cancer trials including updates on SPAR (Professor Stephen Ackland), DYNAMIC-Rectal & DYNAMIC-III (Associate Professor Jeanne Tie), ASCOLT (Dr Mark Jeffrey), RENO (Professor Chris Karapetis), MODULATE & LIBERATE (Professor Niall Tebbutt), MONARCC (Dr Matthew Burge), InterAACT (Dr Amitesh Roy) and OXTOX (Dr Christina Teng).

Upper GI, hepatobiliary, GIST and NET cancer trials including

INTEGRATE II (Associate Professor Nick Pavlakis) ALT-GIST (Professor Desmond Yip), DOCTOR (Professor Andrew Barbour), TOPGEAR (Professor Trevor Leong), DYNAMIC-Pancreas (Dr Belinda Lee), ACTICCA-1 (Dr Jenny Shannon), CONTROL NETs (Associate Professor David Wyld), NABNEC (Associate Professor Mustafa Khasraw) and MASTERPLAN (Dr Andrew Oar).

The meeting was an energising experience, thanks to the passion and collaborative atmosphere that was fostered by everyone who attended. It was an example of the dedication of the GI cancer research community, which the AGITG is proud to lead.

Pictured (L-R): Professor Christian Jobin presents, Amgen stand at the trade hall

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AGITG Innovation Fund Professor Peter Gibbs was awarded the 2019 AGITG Innovation Fund Grant for the FORECAST-1 study.

The study will enrol 30 patients with metastatic colorectal cancer who have exhausted all other treatment options. Samples of their cancers will be obtained and cultured in the laboratory to establish patient derived tumour organoids (PDTOs). A variety of well-established and new therapies will be tested on the organoids, in order to find any effective treatments that can be offered. The best treatment for each patient will then be individually allocated according to the results of these analyses.

"In this trial we can take a personalised approach, trying to work out can we predict which drugs work for which patient. This is just the first of hopefully many studies moving this technology forward."

Merck-AGITG Kristian Anderson Award

Dr Ryan Cohen, pictured above with Merck Managing Director ANZ Leah Goodman and Merck Country Medical Director ANZ Dr Arthur Alston, was awarded the Merck-AGITG Kristian Anderson Award, which will fund the first year of his PhD, titled ‘Predicting colorectal cancer metastatic risk: the tumour immune microenvironment,

circulating exosomes and tumour DNA as biomarkers of disease progression’.

The award provides funding equivalent to $36,700. It is presented each year in honour of Kristian Anderson, who was diagnosed with cancer in his bowel and liver in October 2009 and successfully lobbied the federal government to subsidise cetuximab. He passed away in 2012, leaving behind a legacy as a man who secured federal funding for a drug that has improved the treatment of many colon cancer patients.

“It is an honour to receive this award and I am thrilled to have this support for my research. I hope that it can bring us one step closer to finding better treatments for people with bowel cancer,” says Dr Cohen.

“It is important that Merck continues to support the scholarship and research into gastro-intestinal (GI) cancer through the Merck-AGITG Kristian Anderson Award,” says Leah Goodman, Managing Director of Merck ANZ. “Our aim is to encourage and support a clinician through higher study and to perpetuate the legacy of the late Kristian Anderson, who did much to gain international attention for advancing bowel cancer treatment and personalised medicine.”

Many thanks to Merck for their generous support for the Merck-AGITG Kristian Anderson Award.

About Kristian AndersonKristian Anderson (1975-2012) was diagnosed with cancer in his bowel and liver in October 2009, at age 34. He gained international attention in 2010 as a result of a video he filmed for his wife’s birthday. Anderson was interviewed on The Oprah Winfrey Show alongside his wife, where he used his platform to raise public awareness of bowel cancer.

After his life was prolonged by cetuximab, a drug used in the treatment of advanced colon cancer, Kristian used his profile to successfully lobby the federal government to subsidise it to extend availability. After two years of extensive treatment, he passed away on 2 January 2012. He is survived by his wife Rachel and sons Cody and Jakob. He has left behind a legacy as the man who secured federal funding for cetuximab, which has improved the treatment of many colon cancer patients.

Best New ConceptThe Best New Concept Award was presented to Dr Mark McGregor for his study concept: ‘A phase II study of oncolytic immunotherapy of metastatic neuroendocrine tumours using intralesional rose bengal disodium in combination with pembolizumab’.

INVESTING IN RESEARCH

At the New Concepts Symposium sponsored by Specialised Therapeutics, four new research concepts were presented by Dr Grace Gard, Dr Ivan Ho Shon, Dr Mark McGregor and Dr Yoko Tomita. Specialised Therapeutics Australia Chief Executive Officer Mr Carlo Montagner said he looked forward to seeing this research evolve in the clinic.

“All great breakthroughs begin with a single idea,” he said. “We are proud to again support the New Concepts Symposium and will watch with interest as this concept is progressed through relevant clinical studies before hopefully, changing outcomes.”

Many thanks to Specialised Therapeutics for their sponsorship of the Best New Concept Award.

Best of Posters and Best Fast Forward PresentationThe Best Poster Award was presented to Dr Swetha Sridharan, for ‘Palliative Oesophageal Chemoradiotherapy: A Phase I Clinical Trial’.

Dr Simon Wilkins was awarded the Best Fast Forward Presentation Award for ‘The effect of oversewing double stapled anastomoses in oncological colorectal surgery’.

The Best Poster and Best Fast Forward awards are supported by GenesisCare. Pictured with Dr

Sridharan and Dr Wilkins is Duy Tran, General Manager of SA, GenesisCare.

“GenesisCare are proud to sponsor the Best Poster and Fast Forward Presentation and congratulate both Dr Sridharan and Dr Wilkins for their commitment to improving the health and quality of life of gastro-intestinal cancer patients through clinical research,” says Associate Professor John Leung, GenesisCare.

Many thanks to GenesisCare for their sponsorship of the Best Poster and Fast Forward Presentation awards.

Outstanding Site AwardNaomi Knoblauch received the AGITG Outstanding Site Award on behalf of Calvary Mater Newcastle Hospital, New South Wales. Calvary Mater currently has five AGITG trials open, as well as substudies for ASCOLT and DYNAMIC-Rectal. Notably, staff at this site have recruited double the number of patients expected for the ASCOLT study.

Calvary Mater is responsible for the management of the ClinTrial Refer Oncology NSW smartphone app, which lists actively recruiting studies at 38 sites across the state. This has led to more patients from private centres being referred to the site.

AGITG Member Fundraiser of the YearProfessor Niall Tebbutt became the first AGITG member to be awarded the AGITG Fundraiser of the Year at the Annual Scientific Meeting in

August 2019. Professor Tim Price, AGITG Chair, recognised Professor Tebbutt for his commitment to raising funds for GI cancer research for over four years.

Professor Tebbutt has led two teams on extraordinary fundraising challenges for the GI Cancer Institute in the past including climbing Mt Kilimanjaro, Tanzania (2015) and Mt Aconcagua, Argentina (2017). In 2021, he will lead the third Gutsy Challenge, his most ambitious yet – scaling Mt Himlung Himal in Nepal.

Collectively, the expeditions led by Professor Tebbutt have raised over $280,000 for GI cancer research.

When he was planning the Mt Aconcagua climb, he said, “I wanted it to be a genuine challenge. We knew at the beginning that the stats are that about one in four people who tackle it make the summit. We all knew we were doing something that was difficult.”

Ascending Mt Himlung Himal will be even more challenging as only a handful of teams have successfully scaled it since it was opened in 1992. This journey will also be the most extreme and adventurous Gutsy Challenge to have been attempted by an AGITG member.

Pictured (L-R): Professor Peter Gibbs, Innovation Fund recipient; Dr Ryan Cohen, Merck-AGITG Kristian Anderson Award recipient; Dr Mark McGregor, Best New Concept recipient & representatives from Specialised Therapeutics; Dr Grace Gard, Best New Concept Runner Up

Pictured (L-R): Dr Swetha Sridharan, Best Poster recipient; Dr Simon Wilkins, Best of Fast Forward recipient; Ms Naomi Knoblauch on behalf of Calvary Mater Hospital Newcastle, Outstanding Site Award recipient; Professor Niall Tebbutt, AGITG Member Fundraiser of the Year

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Infrastructure GrantsFunds provided by Cancer Australia to support AGITG infrastructure are managed by the University of Sydney NHMRC Clinical Trials Centre. These funds are not reported in the financial accounts of the AGITG, unless transferred to support specific AGITG expenses.

Funding• Cancer Australia funding is for a

3 year Infrastructure Grant from 1 July 2018 to 30 June 2021. This grant is in collaboration with the University of Sydney NHMRC Clinical Trials Centre and will provide the AGITG $750,000 in infrastructure funding over the grant period.

Research GrantsFunds provided by Cancer Australia, Cancer Council, the National Health & Medical Research Council and the Medical Research Future Fund in support of trial coordination are also managed by the University of Sydney NHMRC Clinical Trials Centre. Funds to support site payments and insurance costs relating to these studies are transferred to the AGITG and are reflected in these financial accounts.

Grants supporting trials conducted during the 2019 financial year are outlined below. AGITG grant income and expenditure during the 2019 year for these trials are included in the 2019 Income Statement.

ACTICCA-1A multi-centre, prospective, randomised, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. observation alone in patients after curative intent resection of Biliary Tract Cancer (BTC).

Funding• Cancer Australia Grant: $163,600

(2016)

ALaCaRT A phase III prospective randomised trial comparing laparoscopic assisted resection versus open resection for rectal cancer. Funding

• NHMRC Grant: $932,586 (2011)• NHMRC Grant: $573,259 (2015)

ASCOLT An international randomised, double blind, placebo controlled phase III multi-centre trial, investigating the effect of aspirin on disease free and overall survival as adjuvant treatment in patients with resected stage II and III colorectal cancer. Funding

• Cancer Australia and Bowel Cancer Australia Grant: $328,000 (2014)

• National Cancer Centre of Singapore: USD$100,000 (2016)

• National Cancer Centre of Singapore: USD$100,000 (2018)

• Cancer Australia Grant: $465,000 (2019)

ASCOLT Translational Study A translational study of samples collected on the international ASCOLT adjuvant colorectal cancer aspirin trial.Funding Perpetual Trustee Company Limited (2015)

• The Jessica & Wallace Hore Foundation: $25,000

• Elaine Haworth Charitable Endowment: $41,522

• The Merrett Endowment: $35,922

CONTROL NETS Capecitabine ON Temozolomide Radionuclide therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study.Funding

• Unicorn Foundation: $200,000 (2015), $105,000 (2017) and $200,000 (2019)

• University of Sydney Bridging Grant: $30,000 (2015)

DOCTOR A randomised phase II trial of preoperative cisplatin, 5-fluorouracil and docetaxel or cisplatin, 5-fluorouracil, docetaxel plus radiotherapy based on poor early response to standard chemotherapy for resectable adenocarcinoma

of the oesophagus and/or oesophageal junction.Funding

• NHMRC Grant: $387,000 (2011)

DYNAMIC-III A study is to compare treatment informed by ctDNA results to standard care in patients with stage III colon cancer. Funding

• Walter and Eliza Hall Institute (Marcus Foundation, USA) $131,787 plus site payments (2017)

DYNAMIC – PANCREAS A study to demonstrate that a ctDNA informed approach to chemotherapy, following surgery for localised pancreatic cancer, could lead to a reduction in the proportion of patients with detectable ctDNA after completion of treatment compared to standard of care. Funding

• Walter and Eliza Hall Institute (Marcus Foundation, USA) $83,107 plus site payments (2018)

DYNAMIC – RECTALThis initial study has been designed to determine whether a ctDNA-based approach to adjuvant therapy will lead to substantially less patients receiving adjuvant therapy.Funding

• Walter and Eliza Hall Institute (NHMRC) $85,107 plus site payments (2017)

MASTERPLAN This study aims to determine if adding stereotactic body radiotherapy (SBRT) to modern chemotherapy (mFOLFIRINOX or gemcitabine/nab-paclitaxel) for patients with high-risk or unresectable (also called locally advanced) pancreatic cancer improves cancer control rates in and around the pancreas.

Funding • Medical Research Future Fund:

$1,512,808 (2018)

NABNEC A Randomised Phase II Study of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment of Gastrointestinal Neuroendocrine Carcinomas.Funding

• NHMRC project grant: $360,750 (2016)

POLEMA phase III randomised study: Avelumab plus fluoropyrimidine-based chemotherapy as adjuvant treatment for stage III dMMR or POLE exonuclease domain mutant colon cancer.Funding

• Medical Research Future Fund: $981,312.50 (2019)

SCOT Short Course Oncology Therapy - A study of adjuvant chemotherapy in colorectal cancer. Funding

• NHMRC Grant: $399,700 (2009)

SPAR Simvastatin with chemotherapy and radiation in preoperative treatment for rectal cancer: a randomized, placebo-controlled phase 2 trial. Funding

• Cancer Society of New Zealand Grant: $149,290 NZD (2015)

• Cancer Council NSW Grant: $449,448 AUD (2016)

• Cancer Australia Grant: $148,857 AUD (2017)

TOPGEAR NHMRC A randomised phase II/III trial of pre-operative chemoradiotherapy versus pre-operative chemotherapy for resectable gastric cancer. Funding

• NHMRC Grant: $756,136 (2013)

GRANTS

Pictured: Dr Belinda Lee

52 53

Pictured (L-R) Board of Directors: Top Row: Professor Stephen Ackland, Professor Bridget Robinson, Mr Dan Kent, Professor Trevor Leong, Professor Eva Segelov, Professor Andrew Barbour, Mr Michael Gordon. Bottom Row: Dr Lorraine Chantrill, Associate Professor Niall Tebbutt, Professor Tim Price, Ms Christine Liddy, Ms Liz Thorp.

“Every person on the AGITG Board of Directors is unwavering in their commitment to putting patients first. It is an honour to chair a group who are so passionate about conducting cutting-edge research that improves the lives of people with GI cancer.”Professor Tim Price, Chair, Board of Directors

Professor Tim Price Chair MBBS DHthSc (Med) FRACP

Professor Price is a Senior Consultant Medical Oncologist, Medical Lead Cancer Program CAHLN and Head of Oncology Research at The Queen Elizabeth Hospital, South Australia. His major clinical interest is in treatment of patients with gastro-intestinal cancer and he is currently involved in an extensive GI clinical trial program. He is a Professor at the University of Adelaide, Colorectal Cancer Stream leader for the South Australian Health and Medical Research Institute, and leader of the GI translational and laboratory research laboratory at the Basil Hetzel Institute. He chairs the current national NHMRC Cancer Council Colorectal Guidelines committee which led to the recently published update. He is also a visiting/honorary Professor at University of Sydney and University of Antwerp.AGITG Committee Positions:Chair, Scientific Advisory CommitteeMember, Corporate Governance CommitteeMember, Upper GI Working PartyChair, International Development Committee

Professor Niall TebbuttDeputy Chair & TreasurerPhD MRCP FRACP

Trained at Oxford University in the UK, Professor Tebbutt has extensive experience in the management of patients with GI cancer. He has a strong involvement in clinical research and has initiated several investigator led or AGITG led clinical trials. He is Director of Medical Oncology at the Olivia Newton-John Cancer Research and Wellness Centre and has published over 140 manuscripts. He has also led 2 fund raising climbs of Mount Kilimanjaro and Mt Aconcagua, collectively raising over $280,000 for GI cancer research. In 2019, he was awarded the AGITG Member Fundraiser of the Year Award.AGITG Committee Positions:Chair, Finance & Risk Management Committee Chair, Lower GI Working Party Member, Scientific Advisory Committee

Professor Trevor LeongCompany SecretaryMBBS MD FRANZCR

Professor Leong is a Consultant Radiation Oncologist, and Past Director of Radiation Oncology at Peter MacCallum Cancer Centre. He is an academic radiation oncologist, actively involved with clinical research programs and has been a principal investigator in numerous phase I/II/III studies relating to GI malignancies. He has been involved with AGITG activities for over 15 years as a trial investigator, member of the SAC, and Board member.AGITG Committee Positions:Member, Corporate Governance CommitteeMember, Upper GI Working PartyMember, Scientific Advisory Committee

BOARD OF DIRECTORS

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BOARD OF DIRECTORS

Dr Lorraine ChantrillB.Sc. (Hons) MBBS (Hons) FRACP PhD

Dr Chantrill is Senior Staff Specialist Medical Oncologist and Head of Department at Illawarra Shoalhaven Local Health District based at Wollongong Hospital. She has served on the AGITG Upper GI Working Party since its inception in 2011 and has chaired the Working Party since August 2014. She was appointed to the Board of Directors of AGITG in August 2016. Dr Chantrill is an executive member of the Australasian Pancreatic Genome Initiative. She is appointed to the Data Safety Monitoring Board of the Australasian Leukaemia and Lymphoma Group. She completed a PhD by research in the Pancreas Cancer Group at The Garvan Institute of Medical Research and has a special interest in the molecular biology of pancreas cancer.AGITG Committee Positions:Chair, Upper GI Working PartyMember, Scientific Advisory CommitteeAGITG ASM Convenor Member, Public Affairs, Marketing & Fundraising Committee

Mr Dan KentGrad.Dip.Mgmt

Mr Kent retired as Chair of the AGITG/GI Cancer Institute Consumer Advisory Panel (CAP) in May 2017 – a role he had undertaken for six years after joining the CAP as a founding member in 2008. In 2015, he was presented with the Inaugural AGITG ‘John Zalcberg OAM Award for Excellence in AGITG Research’ in recognition of his significant and outstanding leadership contribution to AGITG research over a sustained period. He brings a wealth of experience through his active involvement in the AGITG/GI Cancer Institute in a leadership capacity, his involvement in other external groups, and his managerial experiences. He was Director of Bundaberg Distilling and Bundaberg Rum companies from 1988-2000 and formally holds Fellow memberships of the Certified Practising Accountants and the Australian Institute of Management, as well as lived experience as a GI T2N1M0 rectal cancer survivor.AGITG Committee Positions:Chair, Consumer Advisory Panel (2011-17)Member, AGITG Scientific Advisory Committee (2011-2017) Member, Lower Working Party (2011 – 2017)Member, Finance & Risk Management CommitteeMember, Public Affairs, Marketing & Fundraising CommitteeMember, Corporate Governance Committee

Professor Bridget Robinson BMedSc MD (Otago) FRACP

Professor Robinson graduated in Medicine from the University of Otago, New Zealand, then undertook postgraduate training and medical research at the Royal Marsden Hospital and Institute for Cancer Research in London, before returning to a position as Medical Oncologist at Christchurch Hospital. Since 1998 she held a joint appointment at the University of Otago and the Canterbury District Health Board (CDHB), and in 2010 was appointed to the Mackenzie Chair in Cancer Medicine. She initiated and directs the Cancer Society Tissue Bank to support research, and is clinical director of the Mackenzie Cancer Research Group. Her research interests include colorectal cancer, tumour stroma, and effects of obesity, coagulation in cancer, familial cancer, and translational research, as well as clinical trials in cancer patients. Her clinical practice includes breast and colorectal cancers, neuroendocrine tumours, and sarcomas including GIST. She chairs the Canterbury Comprehensive Cancer Centre.

Professor Eva SegelovMBBS (Hons1) FRACP PhD

Professor Segelov is a Medical Oncologist and is Director of Oncology at Monash University and Monash Health, Melbourne, Victoria; previously Senior Medical Oncologist at St Vincent’s Hospital, St Vincent’s Private Hospital and St Vincent’s Clinic and Associate Professor of Medicine, University of New South Wales. She has an interest in academic clinical trials in GI and breast cancer and has been a member of the AGITG since 2003. She has clinical trials expertise, links with national and international trials groups, and extensive experience with adult medical education.AGITG Committee Positions:Chair, Education CommitteeMember, International Development CommitteeCommNETS Convenor

Ms Christine McNamee Liddy AOFAICD BA UNSW

Ms Liddy is a former Board Member and Past President of the Royal Flying Doctor Service of Australia and former National Vice President of the RFDS. She is also a member of the Board of The University of NSW Foundation, Member of the Advisory Board of the Faculty of Arts & Social Sciences, UNSW and the Dame Pattie Menzies Foundation, Board member Pain Foundation Ltd. She is a Fellow and Council Member of St John’s College in the University of Sydney and a Council Member of the Friends of the Sydney International Piano Competition, an Advisory Board Member of the Mosman Art Gallery, and former member of the Digitisation Committee of the State Library of NSW and the RFDS Capital Campaign Committee. Ms Liddy is also a former Board Member of Frontline Defence Services, Australian Army and Air Force, and former Secretary of the Art Gallery Society of NSW (AGNSW). Currently, she is Managing Partner Australian Plantscapes and former Managing Partner of All Purpose Indoor Plant Hire.AGITG Committee Positions:Chair, Public Affairs, Marketing & Fundraising CommitteeChair, Corporate Governance CommitteeMember, Finance & Risk Management Committee

Mr Michael GordonBBus

Mr Gordon is an independent company director serving on the boards and committees of companies in the financial industry. He is a Director of Total Risk Management Pty Ltd, a subsidiary of Russell Investments, which is trustee of the Russell Investments SuperSolution Master Trust. He also chairs the Investment Committee. He is an independent non-executive Director at Yarra Capital Management, a Melbourne based investment management company where he also chairs the Investment Risk and Oversight Committee. Mr Gordon sits on both the Investment Advisory Committee of Altius Investment Management in Sydney as well as the Investment Committee for a large family office based in Brisbane. He has had a distinguished career as a leading investment professional with Perpetual, BNP Paribas, Fidelity International and Schroders.AGITG Committee Positions:Member, Finance & Risk Management Committee Member, Public Affairs, Marketing & Fundraising Committee June 2017

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Operations Executive

Committee

BOARD OF DIRECTORS

Consumer Advisory Panel

Scientific Meeting

Committtee

Scientific Advisory

Committee

Independent Data Monitoring

Committee

Finance & Risk Management

Commitee

Chief Executive

Officer

International Development

Committee

Corporate Governance Committee

FinanceMarketing,

Fundraising & Communications

Administration

Trial Management Committees

Lower GI Working Party

Upper GI Working Party

Public Affairs, Marketing & Fundraising Committee

AGITG & GI CANCER INSTITUTE ORGANISATIONAL STRUCTURE

Professor Stephen AcklandMBBS, FRACP, GAICD

Professor Ackland is a Medical Oncologist based in Newcastle, Executive Member of Hunter Cancer Research Alliance, and Editor-in-Chief of the Asia Pacific Journal of Clinical Oncology. As a member of the Australian Institute of Company Directors since 2007, he has had roles on three not-for-profit boards (including Chairman, Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) 2015-2017, and one small biotech start-up). He has had many engagements with organisations and committees involved in cancer research, particularly clinical trials and in GI cancer. In AGITG he has been a member of the Scientific Advisory Committee (SAC) from 1995, and Chief Investigator on the Asymptomatic Metastatic Colorectal Cancer study, co-investigator on the T3 rectal study, the MAX study, the GOFURTGO Study. He is currently the Australian Chief Investigator, together with Michael Jameson (NZ), of the SPAR study, activated in early 2018. He is passionate about conducting GI clinical trials efficiently and effectively, with timely activation and completion, and providing availability of infrastructure and clinical trials to Australasian oncologists.AGITG Committee Positions:Member, Lower GI Working PartyMember, Public Affairs, Marketing & Fundraising Committee

Ms Elizabeth ThorpBA, Communications in PublicRelationsMs Thorp is an experienced marketing, event, sponsorship and sport marketing professional with a successful career working with leading Australian tourism, financial services, and not-for-profit organisations.

She is also the first female to be accredited as an agent by the Australian Cricketers Association and the Rugby Union Players Association allowing her to combine her marketing skills with business acumen to provide pathways for Australia's leading male and female cricketers, rugby union players, cyclists and netballers.

With a particular focus on women in sport and the progression of women in sport during the digital broadcast revolution, she is committed to seeing professional female athletes attract and retain sponsors and partners who share their athlete's vision of success. She is committed to sharing relationships and networks to ensure a great outcome for internal and external clients. She is voluntarily a Director of a NFP professional and grassroots sporting Organisation (Eastern Suburbs Cricket Club) Easts is the largest junior and senior cricket club in Australia.AGITG Committee PositionsMember, Public Affairs, Marketing & Fundraising Committee

Professor Andrew BarbourMBBS, PhD, FRACS

Professor Barbour specialises in the treatment of oesophageal, gastric, and pancreatic diseases, as well as melanoma and soft tissue tumours. He is a Surgical Oncologist, head of the Surgical Oncology Lab at the University of Queensland School of Medicine with a research interest in the treatment of cancer. As a clinical researcher, he has been active in the conduct of phase I/II/III clinical trials. He is the Principal Investigator for investigator-initiated, multicentre phase II trials in oesophageal (DOCTOR trial) and pancreatic cancer (GAP Trial), funded by the NHMRC; the MASTERPLAN trial funded by Medical Research Future Fund and the DOCTOR Genomics Study sponsored by the AGITG. These studies are aimed at developing personalized, precision therapy for cancer. He is also a member of the Australian Pancreatic Cancer Genome Initiative that has published several key studies that have improved our understanding of pancreatic cancer. AGITG Committee Positions:Deputy Chair, Upper GI Working PartyMember, Scientific Advisory Committee

BOARD OF DIRECTORS

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Scientific Advisory CommitteeThe Scientific Advisory Committee (SAC) is the focal point for widespread discussion of research ideas. Its members, who are drawn from the AGITG and the NHMRC Clinical Trials Centre, are experts in the fields of medical oncology, surgery, radiation oncology, biological research, quality of life research, statistics and study coordination.

The key role of the SAC is to determine the research priorities of the AGITG. The committee’s open dialogue leads to the development of a common language, interaction and commitment to trials by a broad range of medical specialists, allied

health professionals and health consumers.

SAC meetings foster a spirit of collaboration between a diverse group of people who share a common goal: to improve patient care through gastro-intestinal (GI) cancer clinical trials.

Upper GI and Lower GI Working PartiesThe AGITG Upper GI and Lower GI Working Parties represent the disciplines of medical oncology, surgery, radiation oncology, statistics, translational science and study coordination. The Upper GI Working Party focuses on cancers of the oesophagus, gallbladder, pancreas, stomach and liver, while

the Lower GI Working Party looks at cancer of the bowel, rectum and anus.

The Working Parties meet bi-monthly to:• Facilitate research activities to

address the AGITG Research priorities

• Develop and/or facilitate new clinical research concepts

• Review the scientific merit of research proposals

• Explore funding and feasibility opportunities

• Nominate Principal Investigators• Nominate Trial Management

Committee members

Pictured (L-R): Professor Niall Tebbutt, Dr Simone Steel, Dr Matthew Burge, Associate Professor Lara Lipton

SCIENTIFIC ADVISORY COMMITTEE & WORKING PARTIES

Scientific Advisory Committee Professor Tim Price Chair, Medical Oncologist

Dr Lorraine ChantrillMedical Oncologist

Professor Niall TebbuttMedical Oncologist

Mrs Jan MumfordChair of the Consumer Advisory Panel

Dr Katrin SjoquistMedical Oncologist

Professor John Zalcberg OAMMedical Oncologist

Conjoint Professor David GoldsteinMedical Oncologist

Professor Mike FindlayMedical Oncologist

Professor John SimesMedical Oncologist

Professor Trevor LeongRadiation Oncologist

Associate Professor Andrew KneeboneRadiation Oncologist

Professor Andrew BarbourSurgeon (Upper GI)

Dr Dan CroaghSurgeon (Hepato-Pancreo-Biliary)

Associate Professor Andrew StevensonSurgeon (Lower GI)

Associate Professor Tarik SammourSurgeon (Lower GI)

Professor Val GebskiStatistician

Professor Nik ZepsBiological Scientist

Associate Professor Jeanne TieMedical Oncologist

Ms Katie BentonUpper GI & Surgical Dietitian

Associate Professor Chris HemmingsHistopathologist

Upper GI Working PartyDr Lorraine Chantrill Chair, Medical Oncologist

Professor Andrew BarbourDeputy Chair, Surgeon

Ms Rebecca AsherStatistician

Professor Alexander BoussioutasGastroenterologist

Ms Katie BentonUpper GI & Surgical Dietitian

Dr Yu Jo ChuaMedical Oncologist

Professor Michael FindlayMedical Oncologist

Dr Dominque LeeRadiation Oncologist

Professor Barbara LeggettHepatologist

Associate Professor Lara LiptonMedical Oncologist

Associate Professor John LubelHepatologist

Professor John MariadasonTranslational Scientist

Lower GI Working PartyProfessor Niall TebbuttChair, Medical Oncologist

Professor Chris KarapetisDeputy Chair, Medical Oncologist

Professor Steve AcklandMedical Oncologist

Dr Matthew BurgeMedical Oncologist

Dr Julie ChuRadiation Oncologist

Dr Connie DiakosMedical Oncologist

Professor Alexander EngelSurgeon

Mr David EspinozaStatistician

Associate Professor Cherry KohSurgeon

Mr Robin MitchellDeputy Chair, Consumer Advisory Panel

Professor Rob RamsayTranslational Scientist

Associate Professor Jeremy ShapiroMedical Oncologist

Associate Professor Oliver SieberTranslational Scientist

Associate Professor Jeanne TieMedical Oncologist

Dr Zee Wan WongMedical Oncologist

Professor Nik ZepsBiological Scientist

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TREASURER’S REPORT

2019 represented one of the most active years in the recent history of the AGITG and, consequently, resulted in the highest level of expenditure on scientific trials over the last 10 years.

AWARDWINNER

AGITG

2019

Professor Niall TebbuttDeputy Chair & Treasurer AGITG Member Fundraiser of the Year

This landmark is noteworthy not solely for the level of expenditure but for the range of funding sources which have supported it. This achievement is significant given that research funding is subject to increasing levels of qualitative milestones aligned to all scientific trials.

The table below shows that the expenditure of over $7 million in 2019 is the highest level by the AGITG over the last 10 years. The organisation has contributed $50m in spending since January 2009.

The 2019 financial year expenditure has supported the progress of 18 scientific trials, which have outcomes influencing the treatment of pancreas, bowel, gallbladder, oesophagus and stomach cancers.

Funding sources included the pharmaceutical industry, private foundations, donor support through pledged and general donations, State and Federal Government bodies, academic institutions, internationally based research institutions, and the accumulated surplus and donation reserves of the AGITG.

This level of activity represents our development in leading scientific trials, collaborating with local and international research organisations, initiating pilot studies identified through our membership, and supporting initiatives across the gastro-intestinal (GI) cancer research community. Achieving this level of expenditure in a funding environment where there are increasing

constraints at all levels is a major accomplishment.

As I prepare this report, the impact on Australian and international communities from the Coronavirus pandemic continues to evolve. The financial management of the AGITG since incorporation in 2000 has incorporated conservative financial measures, allowing us to be well placed to manage an external event like this. In response to the identified impact from the Coronavirus, the management of the AGITG have instigated a range of actions, incorporating guidelines from Government and Health Authorities.

Whilst we share the community’s concerns about the impact of the Coronavirus, the AGITG has not lost sight of the impact on our community from GI cancers, the responsibility which we have in meeting the milestones expected from research partners, and benefits to the community from the outcomes of our research activities. Accordingly, the measures being adopted are directed at securing the safety of our staff, research partners and members, responsible financial management, and measured progression of current and future research.

The 2019 financial year resulted in the net assets of the AGITG increasing by $212,518. This increase has been achieved through a deficit from operations of $1,115,397, offset by donations received to the Donation Reserves of $1,327,912.

The operating deficit includes the $7,281,578 expenditure on trial and site activity. This expenditure was incurred with a commitment from the Donation Reserves to support the scientific outcomes from research opportunities and ensure measured financial management.

As we turn to the 2020 financial year, we express our appreciation from and ongoing commitment to government, industry, and the various institutions who engage with us in our research activities. We thank our members and donors for their contribution to our achievements. We will not lose focus on the importance of the objectives of the AGITG, but we understand that this will be tempered by the impact of the Coronavirus. As has been the mark of our achievements thus far, your support is a key component to our ability to contribute to research in GI cancers.

The engagement from the members of the Finance and Risk Management Committee, our CEO, the support team within the AGITG and external accountants has enabled the AGITG to build a strong platform from which we manage our financial affairs. I thank them for their contribution and am confident that their ongoing support will guide us through the 2020 financial year.

Professor Niall Tebbutt PhD MRCP FRACP Deputy Chair & Treasurer

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INCOME STATEMENT Statement of profit or loss and other comprehensive income for the year ended 31 December 2019

2019 2018

$ $

Revenue 6,511,324 4,058,187

Other income 1,927,863 1,266,758

Administration/Infrastructure expense (513,314) (517,254)

Depreciation and amortisation expense (7,675) (13,066)

Impairment of Intangible Assets (12,587) (7,320)

Trial and Site Costs (7,281,578) (3,690,077)

Scientific Events (961,681) (905,771)

Marketing/Fund Raising costs (777,749) (645,542)

(Deficit) / Surplus before income tax (1,115,397) (454,085)

Income tax expense -

(Deficit) / Surplus for the year (1,115,397) (454,085)

(Deficit) / Surplus for the year (1,115,397) (454,085)

Other comprehensive income after income tax

Other comprehensive income for the year, net of tax - -

Total comprehensive income for the year (1,115,397) (454,085)

Total comprehensive income attributable to members of the entity (1,115,397) (454,085)

These Financial pages are an extract from the audited accounts for the financial year ended 31 December 2019.

BALANCE SHEETSTATEMENT OF FINANCIAL POSITION AS AT 31 DECEMBER 2019

2019 2018

$ $

Assets

CURRENT ASSETS

Cash and cash equivalents 3,448,550 4,031,020

Financial Assets 9,349,361 8,692,947

Trade and other receivables 831,298 627,917

Other assets 161,276 72,838

TOTAL CURRENT ASSETS 13,790,485 13,424,722

NON-CURRENT ASSETS

Property, plant and equipment - -

Intangible assets 67,288 81,745

TOTAL NON-CURRENT ASSETS 67,288 81,745

TOTAL ASSETS 13,857,773 13,506,467

Liabilities

CURRENT LIABILITIES

Trade and other payables 764,201 380,295

Other short-term liabilities 2,018,589 2,875,446

TOTAL CURRENT LIABILITIES 2,782,790 3,255,741

NON-CURRENT LIABILITIES

Long-term provisions 73,230 74,097

Other long-term liabilities 3,380,079 2,767,473

TOTAL NON-CURRENT LIABILITIES 3,453,309 2,841,570

TOTAL LIABILITIES 6,236,099 6,097,311

NET ASSETS 7,621,674 7,409,156

EQUITY

Reserves 4,526,377 4,503,214

Retained Earnings 3,095,297 2,905,942

TOTAL EQUITY 7,621,674 7,409,156

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W E

T H A N K

Y O U

Thanks to the support from our committed and passionate supporters, we continue to put patients at the centre of our research, saving and improving lives by accelerating the pace of discoveries that lead to cures.

Community support is critical for our dedicated group of research and health professionals to translate bold new ideas in to life-saving clinical trials that help people with GI cancer as quickly as possible. There have been a number of ways our supporters have made a difference to the lives of people diagnosed with gastro-intestinal (GI) cancer, their families and future generations.

Donations Through our regular appeals, donations have been received which enable us to conduct our clinical trials that lead to better health outcomes for patients. All donations, no matter what size, have contributed to trials initiated this past year. We have also continued to receive and grow the number of regular giving supporters, which provides us with the financial stability to plan for the future.

To make an online donation please visit www.gicancer.org.au/donate

The Gutsy Challenges and Community Fundraising In 2019 we had some great fundraising successes thanks to our generous community supporters.

We had 60 fundraisers take part in a range of events including the Western Australia Cape to Cape and New Zealand Southern Alps Gutsy Challenges.

Our community fundraisers also hosted some incredible events such as the St Rita’s College Fashion Fundraiser, Macquarie Bank’s Trivia Night supporting oesophageal cancer, and the annual Dominic Colagiuri Football Fundraiser. In addition, we had ten runners participate in marathons around Australia to raise funds for GI cancer research.

Funds raised through the Gutsy Challenges in 2019 will contribute towards the AGITG Innovation Fund grant. This grant is awarded

YOUR SUPPORT MAKES THE DIFFERENCE

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Individuals• William & Susan Andrews• Allyn Colgan• Jane Cullam• Daniel Goulburn OAM & family• Yvonne Horton• James Kelly• Ann Waterford

Organisations/Foundations• Alan Bishop Fund• Dillon Partners• Dorman Family Foundation• Macquarie Group Limited• Terry & Maureen Hopkins

Foundation• The Spencer Gibson Foundation• The Unicorn Foundation

Through the years, we are very grateful to those individuals who have left a legacy in support of GI cancer research.

• Estate of the late Nathalie Kulakowski• Estate of the late Kenneth Alfred Iles• Estate of the late Monica Bernadette Nolen• Estate of the late Ralph Colin Murdoch Toplis• Estate of the late Susan Joan Cross

We are very grateful to all those individuals who have informed us that they have decided to make an exceptional commitment to leave a gift to GI cancer research in their Will.

• Chris Badger• Frances Blackwell• Robert Cabion• Nella Calati• Kerry Croydon• Bill Fechner• Neville Gallard• Ian Hawkins• Ruth Henwood• Bruce Holzhauser• Helen Illsley• Trish Johnstone• Jennifer Jones• Isabel Kirsh• Nicky Lancaster• Peter Learmonth• Sarah McGoram• Gary Reid• Bernice Summerfield-Sinn• Elizabeth Thorp• Jenny Wells• Andrew Wells• Susan Wong

We are pleased to recognise the generosity and commitment of our donors who have generously supported Gastro-Intestinal cancer research in 2019.

HONOUR ROLL

We have done our utmost to ensure the information listed here is accurate. If there is anything you would like us to update please email info@gicancer.org.au

Pledged Bequests$1,000 – $9,999

$10,000+ Estates

Individuals• Craig Adam• Luke Adcock• Terry Bidmade• Shaun Bonett• Ron Brierley• John Brimacombe• Susan Buxton• Robert Cabion• Y & I Carrick-Allan• Evelyn Chan• Steven Davenport• Doug Dockery• Lou-Anne Folder• Elisabeth Foley• Sonia Foo• Fiona Foo• Fred Frohlich• Yvonne Goldbloom• Jean Gooey• Michael & Justine Gordon• Peter Griffiths• Michelle Groves• Lynn Hibbard• Robert Holland• Louise Keady• Jenni Kennedy• Isabel & George Kirsh• Jeanette Lau Gooey• Paula & Ross Laughlan

• Robert Lawry• Jon Lennon-George• Peter Lynch• Bill Maher• Barbara Marheine• Catherine Marshall• David Martin• Christine McDonald• Robert McDowell• James McGill• Mark McGregor• John Mcilvenna• Peter McKee• Marie-Luise Miller• Catherine Moroney• Ian & Judi Mundell• Melissa Norris • Graeme Oldmeadow• Davina Owens• Mary Padbury• Michael Paduano• Rose Powell• Brian & Helen Read• Frances Rolfe• Sandra Rollo• Patricia Scott• Phillip & Ruth Shirriff• Janet Souter• Graham Stevens• Margaret Stevens

• Peter Stockdale• Kate Stokes• John & Gillian Storey• Lance Sue-Kee• June Summers• Rosemary Taylor• Niall Tebbutt• Julian Tertini• Chris Thomas• Daryl & Annette Thomas• Miriam Tonkin• Andrew Wells• Brenda Wells• Paul White• Bill Willocks• Vivienne Windsor• Desmond Yip

Organisations/Foundations• Adelaide Oncology &

Haematology• BODYSYSTEM Physio• Carlton Family Foundation• GGB Wealthcare Pty Ltd• Hickory Construction Group

Pty Ltd• Rotary Club of Brookfield• SH & DA Oldknow Pty Ltd• Specialised Therapeutics

Australia

annually to researchers, providing them with the opportunity to conduct ground-breaking research in areas that have not been studied before.

It is thanks to the support of the community that we are able to achieve this.

To learn more see www.gicancer.org.au/gutsy

Bequests We were privileged to receive a significant bequest from a generous supporter during the year. Through leaving a gift in his Will, this supporter has left a meaningful legacy for future generations. There are many reasons why people choose to leave a bequest – most often it is a very personal decision. No matter whether the donation is large or small, bequests enable cutting-edge research into new treatments for patients diagnosed with GI cancer beyond our lifetime.

To learn more see www.gicancer.org.au/yourwill or for a confidential conversation please call Nicky on 1300 666 769.

Honouring a Loved One We are very grateful for those family members who have lost someone throughout the year and chosen to honour their loved one through In Memory donations, often collected during the funeral in lieu of flowers. These donations create something positive by supporting innovative research for improved outcomes for future generations.

To arrange for personalised In Memory donation cards or for more information please contact our Database Coordinator, Praj on 1300 666 769.

Volunteers Throughout the year we have been supported by a number of skilled volunteers who have each made a real difference to our

ability to fund our clinical trials. In addition, supporters including cancer survivors and their families have generously come forward to share their stories, which assists us to raise awareness of the often hidden GI cancers and promote the difference our clinical trials are making to the lives of patients.

Community support is vital in funding GI cancer clinical trials research now and in to the future. For more information on how to get involved, please contact us on 1300 666 769 or visit www.gicancer.org.au/getinvolved.

Pictured: Community fundraisers

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Thank you to our members who volunteer their time, expertise and commitment, to our sponsors who support our activities financially, and to our donors who give generously to continue to improve the outcomes of people with GI cancer. Your support and dedication is vital to our work in delivering the best practice medical treatment for patients.

Sponsors

Platinum Sponsor

Gold Sponsor

THANK YOU

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Australasian Gastro-Intestinal Trials Group & GI Cancer Institute · ABN 34 093 854 267Locked Bag M250, Camperdown NSW 2050 · T. 1300 666 769 · F. 02 9562 5348