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CLINICAL TRIALS / STUDIES AT THE BANK OF CYPRUS ONCOLOGY CENTRE Page 1 of 7 Last updated: September 2021 Currently active YEAR OPENED TRIAL/STUDY NAME Investigator(s) STATUS 2013 Development of a module to supplement the EORTC Core instruments for assessment of Health Related Quality of Life in patients with Anal Cancer EORTC (phases I-IV) Dr. Vasiliou Recruitment open 2013 Creation of symptom based questionnaires based on current guidelines for module development: the development of a time- efficient procedure GIST EORTC (phases I-IV) Dr. Vasiliou Recruitment open 2014 Adaptation of the EORTC IN-PATSAT32 in a core cancer patient satisfaction with care questionnaire (PATSAT-CORE x items) and development of a complimentary module for the outpatient setting EORTC (phases I-IV) Dr. Vasiliou Recruitment open 2015 Development of an EORTC cancer survivorship quality of life questionnaire EORTC (Phase I-IV) Dr. Vasiliou Recruitment open 2017 Development of an EORTC quality of life questionnaire for patients with Pancreatic Neuroendocrine Tumors (P-Net): EORTC Phases I-III Dr. Vasiliou Dr. Papamichael Recruitment open 2017 Development of an EORTC questionnaire for individuals at risk for a Hereditary Cancer Predisposition Syndrome: the EORTC QLQ-HCPS Dr. Vasiliou Recruitment open 2018 Optimizing the diagnostic value of SPECT myocardial perfusion imaging under the influence of liver activity MPI-LIVER -Research Innovation Foundation (RIF) Dr. Frangos Active 2018 Optimizing the diagnostic value of postsurgical I-123 SPECT thyroid imaging and applying patient-specific dosimetry for radioiodine ablation of thyroid remnants Research Innovation Foundation (RIF) Dr. Frangos Active 2019 Platform for Biosciences and human health in Cyprus: MicroCT Enabled and Synchrotron Radiation Enabled Analyses (BIOMERA) Research Innovation Foundation (RIF) Dr. Andreopoulos Dr. Constantinidou Active 2019 Investigation of the predictive and prognostic role of liquid biopsies in NSCLC patients treated with the anti- PD-1 inhibitor Pembrolizumab (PRELIFE) Research Innovation Foundation (RIF) Dr. Charalambous Active 2020 (IMMUcan) falls under the platform SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access-EORTC Dr. Papamichael Recruitment open

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Page 1: Currently active - bococ.org.cy

CLINICAL TRIALS / STUDIES AT THE BANK OF CYPRUS ONCOLOGY CENTRE

Page 1 of 7 Last updated: September 2021

Currently active

YEAR OPENED

TRIAL/STUDY NAME

Investigator(s)

STATUS

2013

Development of a module to supplement the EORTC Core instruments for assessment of Health Related Quality of Life in patients with Anal Cancer EORTC (phases I-IV)

Dr. Vasiliou

Recruitment open

2013

Creation of symptom based questionnaires based on current guidelines for module development: the development of a time-efficient procedure GIST EORTC (phases I-IV)

Dr. Vasiliou

Recruitment open

2014

Adaptation of the EORTC IN-PATSAT32 in a core cancer patient satisfaction with care questionnaire (PATSAT-CORE x items) and development of a complimentary module for the outpatient setting EORTC (phases I-IV)

Dr. Vasiliou

Recruitment open

2015

Development of an EORTC cancer survivorship quality of life questionnaire EORTC (Phase I-IV)

Dr. Vasiliou

Recruitment open

2017

Development of an EORTC quality of life questionnaire for patients with Pancreatic Neuroendocrine Tumors (P-Net): EORTC Phases I-III

Dr. Vasiliou

Dr. Papamichael

Recruitment open

2017

Development of an EORTC questionnaire for individuals at risk for a Hereditary Cancer Predisposition Syndrome: the EORTC QLQ-HCPS

Dr. Vasiliou

Recruitment open

2018

Optimizing the diagnostic value of SPECT myocardial perfusion

imaging under the influence of liver activity –MPI-LIVER -Research

Innovation Foundation (RIF)

Dr. Frangos

Active

2018

Optimizing the diagnostic value of postsurgical I-123 SPECT thyroid

imaging and applying patient-specific dosimetry for radioiodine

ablation of thyroid remnants

Research Innovation Foundation (RIF)

Dr. Frangos

Active

2019

Platform for Biosciences and human health in Cyprus: MicroCT

Enabled and Synchrotron Radiation Enabled Analyses –

(BIOMERA) Research Innovation Foundation (RIF)

Dr. Andreopoulos

Dr. Constantinidou

Active

2019

Investigation of the predictive and prognostic role of liquid biopsies

in NSCLC patients treated with the anti- PD-1 inhibitor

Pembrolizumab – (PRELIFE)

Research Innovation Foundation (RIF)

Dr. Charalambous

Active

2020 (IMMUcan) falls under the platform SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access-EORTC

Dr. Papamichael Recruitment open

Page 2: Currently active - bococ.org.cy

CLINICAL TRIALS / STUDIES AT THE BANK OF CYPRUS ONCOLOGY CENTRE

Page 2 of 7 Last updated: September 2021

Currently active cont.

YEAR OPENED

TRIAL/STUDY NAME

Investigator(s)

STATUS

2020

A phase II, randomized, active-controlled, multi-center study

comparing the efficacy and safety of targeted therapy or cancer

immunotherapy guided by genomic profiling versus platinum-based

chemotherapy in patients with cancer of uknown primary site who

have received three cycles of platinum doublet chemotherapy –

(CUPISCO) - ROCHE

Dr. Fotopoulos Recruitment open

2021

PREdictive BIOMarkers of response to immunotherapy and

chemotherapy in patients with Advanced Solid Tumours

(PREBIOM): A Non Interventional Study - BOCOC

Dr. Charalambous Active

2021 An interdisciplinary approach for the management of the elderly multimorbid patient with breast cancer therapy induced cardiac toxicity –(CARDIOCARE) - EU - H2020

Dr. Constantinidou

Dr. Papamichael

Dr. Marcou

Dr. Kakouri

Active

2021

Cancer, allostatic load, and regulation of emotions: how stress and emotion regulation impact mental and physical health of breast and testicular cancer patients –(CARE) Cyprus Cancer Research Institute (CCRI)

Dr. Constantinidou

Active

2021 Clinicopathological features and oncological outcomes of patients

with early age onset colorectal cancer –(REACCT) Dr. Papamichael Active

2021 Prognostic significance of estrogen receptor-β as a novel

biomarker responsible for tamoxifen resistance in Cypriot Breast

cancer patients (TAMRES)

Dr. Marcou Active

2021 A multicentre study of overall survival, locoregional control and

distant metastasis in anal cancer utilising distributed learning-

(atomCAT2)

Dr. Vasiliou Active

2021

Mechanistic and prognostic implications of the epigenetic

acetyltransferase naa40 in cancer chemoresistance-

(ChemoresistNAT)

Cyprus Cancer Research Institute (CCRI)

Dr. Papamichael Active

2021

A technologically integrated digital platform for personalised

predictions o f metastatic brain tumour development and

response to treatment- (PROTEAS)

Cyprus Cancer Research Institute (CCRI)

Dr. Theodorou Active

2021 Expansion of Anastasios Leventis Clinical Trials Units clinical

research activity and infrastructure

Cyprus Cancer Research Institute (CCRI)

Dr. Papamichael Active

2021 Understanding radiation-induced lung fibrosis via an in-silico disease progression and management platform

Dr. Vomvas Active

Page 3: Currently active - bococ.org.cy

CLINICAL TRIALS / STUDIES AT THE BANK OF CYPRUS ONCOLOGY CENTRE

Page 3 of 7 Last updated: September 2021

Recruitment closed but patients on treatment or follow – up

YEAR OPENED

TRIAL/STUDY NAME

Investigator(s)

STATUS

2011

(Colorectal Cancer Trial) - Is greater downstaging and tumour

regression observed when surgery is delayed to 12 weeks after

completion of Chemoradiotherapy vs 6 weeks? Royal Marsden

Dr. Vasiliou

Recruitment closed

Follow - up

2016

A Disease Registry Study To Prospectively Observe Treatment Patterns And Outcomes In Patients With Her2-Positive Unresectable Locally Advanced Or Metastatic Breast Cancer –(ML28801) ROCHE HELLAS

Dr. Marcou

Dr. Kakouri

Recruitment closed Follow - up

2016

A Phase II study of Switch Maintenance Pembrolizumab in patients with Non Small Cell Lung Cancer (NSCLC) who do not progress after First Line Platinum Doublet Chemotherapy- (SWIPE) BOCOC

Dr. Charalambous

Recruitment closed Patients on treatment and Follow – up

2018

A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum-based doublet as a first-line treatment of recurrent or Stage IV PD-L1+ non-small cell lung cancer - Merck KG - Javelin

Dr. Charalambous

Dr. Orphanos Dr. Kyriacou

Recruitment closed Query and closeout

2019

Single-arm phase II study of panitumumab rechallenge in

combination with oxaliplatin or irinotecan-based chemotherapy

in patients with RAS wild type advanced colorectal cancer (A-

REPEAT) - HeCOG

Dr. Papamichael

Dr. Kountourakis

Recruitment closed Follow - up

Page 4: Currently active - bococ.org.cy

CLINICAL TRIALS / STUDIES AT THE BANK OF CYPRUS ONCOLOGY CENTRE

Page 4 of 7 Last updated: September 2021

New trials/studies coming soon…

YEAR OPENED

TRIAL/STUDY NAME

Investigator(s)

STATUS

2021

A randomized phase III study of neoadjuvant chemotherapy followed by surgery Versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma - EORTC (STRASS 2)

Dr. Constantinidou CA pending

2021

ReX-C system implementation in patients receiving home-based oral oncolytic therapy – Dosentrx Ltd, Israel

Dr. Marcou

Regulatory Approved Coming soon

2021

Η χρήση της Τηλεϊατρικής στην παρακολούθηση ασθενών με

Κολοορθικό Καρκίνο Σταδίου ΙΙ και Σταδίου ΙΙΙ Dr. Papamichael

Regulatory Approved Coming soon

Page 5: Currently active - bococ.org.cy

CLINICAL TRIALS / STUDIES AT THE BANK OF CYPRUS ONCOLOGY CENTRE

Page 5 of 7 Last updated: September 2021

Older trials which are now closed

YEAR OPENED

TRIAL NAME

Investigator(s)

YEAR CLOSED

1999

Multicenter international study of oxaliplatin/5fu-lv in the

adjuvant treatment of colon cancer (MOSAIC)study.

–SANOFI AVENTIS

Dr. Papamichael

2006

2000

A randomised trial to assess the role of irinotecan and oxaliplatin

in advanced colorectal cancer - focus-(MRC -Medical Research

Council-Uk) “FOCUS” study. -MRC

Dr. Papamichael

2008

2000

Multicentre Phase III open label randomised trial comparing cpt-11 in combination with 5-fu/fa infusional regimen to the same 5 fu/fa infusional regimen alone as adjuvant treatment of stage III colon cancer“PETACC-3” –PFIZER

Dr. Papamichael

2008

2001

The international tirapazone triple trial-SANOFI

Dr. Papamichael

2003

2002

A Phase III, randomized efficacy and safety study of the combination chemotherapy with tirapazamine + cisplatin + vinorelbine in subjects with inoperable, previously untreated, non-small cell lung cancer.

Dr. Adamou

2003

2002

A multicenter Phase III randomized trial comparing doxorubicin

and cyclophosphamide followed by docetaxel (AC-T), with

doxorubicin and cyclophosphamide followed by docetaxel and

trastuzumab (AC-TH) and with docetaxel, platinum salt and

trastuzumab (TCH) in the adjuvant treatment of node positive

and high risk node negative patients with operable breast cancer

containing the her2neu alteration. BCIRG (006)-ROCHE

Dr. Adamou

Dr. Kakouri

2015

2002

A multicenter Phase III randomized trial comparing docetaxel in

combination with doxorubicin and cyclophosphamide (TAC)

versus doxorubicin and cyclophosphamide followed by docetaxel

( AC-T ) as adjuvant treatment of operable breast cancer her2neu

negative patients with positive axillary lymph nodes.

BCIRG (005)-ROCHE

Dr. Adamou

Dr. Kakouri

2014

2003

A randomized Phase III Study of follow up with or without

adjuvant Gefitinib (Iressa) following chemotherapy in patients

with advanced non-small cell lung cancer. (8021)- EORTC

Dr. Papamichael

Dr. Decatris

2012

2013

Screening Platform of the EORTC for Clinical Trials Advanced Colorectal cancer (SPECTAcolor)

Dr. Papamichael

2019

2013

An open-label, extension (rollover) study of vemurafenib in patients with BRAFv600 mutation-positive malignancies previously enrolled in an antecedent vemurafenib protocol. ROCHE

Dr. Decatris

Dr. Orphanos Dr. Kordatou

2020

Page 6: Currently active - bococ.org.cy

CLINICAL TRIALS / STUDIES AT THE BANK OF CYPRUS ONCOLOGY CENTRE

Page 6 of 7 Last updated: September 2021

Older trials which are now closed cont.

YEAR OPENED

TRIAL NAME

Investigator(s) YEAR

CLOSED

2003

Three dimensional conformal radiotherapy / intensity modulated

radiotherapy alone vs three dimensional conformal therapy /

intensity modulated radiotherapy plus adjuvant hormonal

therapy in localized t1b-c, t2a, n0, m0 prostatic carcinoma.

EORTC radiotherapy group – a Phase III randomized study

EORTC (22991)

Dr. Kitsios

Dr. Andreopoulos

2014

(extended data

collection and query resolution

2020)

2004

International prophylactic cranial irradiation trial. A multicenter

randomized trial of high versus standard doses of prophylactic

cranial irradiation in limited small cell lung cancer complete

responders - EORTC (2003-08004) pc199-eulint1

Dr. Katodritis

2010

2004

Prophylactic cranial irradiation in extensive disease small cell

lung cancer EORTC (22993-08993).

Dr. Katodritis

2010

2005

A randomized, open- label Phase II Study evaluating the efficacy

and safety of FOLFOX6 + Cetuximab versus FOLFIRI plus

Cetuximab as first line therapy in patients with metastatic

colorectal cancer. CECOG study

Dr. Papamichael

2008

2007

International, Randomized, Open-Label, Phase III Trial of

Paclitaxel/Carboplatin plus PF3512676 versus

Paclitaxel/Carboplatin alone as first-line treatment of patients

with advanced non-small cell lung cancer. - (A8501001) PFIZER

Dr. Decatris

2008

2007

Immediate or early salvage post-operative external radiotherapy

combined with concomitant and adjuvant hormonal treatment

versus immediate or early salvage postoperative external

radiotherapy alone in pT3a-b R0-1 cN0M0 / pT2R1 cN0M0,

Gleason score 5-10 prostatic carcinoma. A Phase III study

(22043-30041) EORTC

Dr. Kitsios

2013

2007

A Multicenter, Randomized, Double-Blind, Phase III Study Of

Sunitinib In Metastatic Colorectal Cancer Patients Receiving

Irinotecan, 5-Fluorouracil And Leucovorin (Folfiri) As First Line

Treatment. “THE SUN TRIAL”-PFIZER

Dr. Papamichael

2010

2008

A Phase III Randomized, Double-blind, Placebo Controlled Trial

Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to

Gemcitabine, Cisplatin and Placebo in First-Line Treatment of

Patients with Stage IIIb with effusion and Stage IV non-small cell

lung cancer. “NExUS” study. BAYER

Dr. Charalambous

Dr. Decatris

2011

Page 7: Currently active - bococ.org.cy

CLINICAL TRIALS / STUDIES AT THE BANK OF CYPRUS ONCOLOGY CENTRE

Page 7 of 7 Last updated: September 2021

Older trials which are now closed cont.

YEAR OPENED

TRIAL NAME

Investigator(s)

YEAR CLOSED

2008

A multinational randomized double blind study comparing the

efficacy of Aflibercept once every 2 weeks versus placebo in

patients treated with Gemcitabine for metastatic pancreatic

cancer (Vanilla) –SANOFI AVENTIS

Dr. Papamichael

2011

2012

Treatment of patients with KRAS wild type advanced colorectal cancer with 5-fluorouracil (5-FU) or 5-FU plus an Epidermal Growth Factor Receptor inhibitor (cetuximab) based on a Comprehensive Geriatric Assessment. EORTC.

Dr. Papamichael

2018

2012

An open-label, randomized, controlled, multi-center, Phase I/II trial investigating 2 EMD 525797 doses in combination with cetuximab + irinotecan versus cetuximab + irinotecan alone, as second-line treatment for subjects with k-ras wild type (WT) metastatic colorectal cancer (mCRC). Subjects with k-ras WT mCRC will be eligible for enrollment if they are refractory to or progressive after first-line chemotherapy with an oxaliplatin-containing therapeutic regimen.-(POSEIDON)-MERCK

Dr. Papamichael 2014

2012

A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer (IMM-101-002)- IMMODULON

Dr. Papamichael 2017

2014

A prospective, multicenter, randomised, open-label, activecontrolled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imatinib - AB Science

Dr. Orphanos Dr. Papamichael

2018

2016

A multi-centre randomised clinical trial of biomarker-driven maintenance treatment for first-line metastatic colorectal cancer (MODUL) A Phase II study - ROCHE HELLAS

Dr. Papamichael Dr. Kountourakis

Dr. Papanastasopoulos

2019

2017

Maintenance therapy with trabectedin versus observation after

first line treatment with doxorubicin of patients with advanced

or metastatic soft tissue sarcoma- EORTC

Dr. Constantinidou

Dr. Katodritis

2018

2016

A prospective, multicentre, double-blind, randomized, placebo-controlled, phase 3 study to evaluate efficacy and safety of masitinib with irinotecan in patients with advanced-stage esophagogastric adenocarcinoma who have relapsed after first-line chemotherapy AB SCIENCE

Dr. Kountourakis Dr. Papamichael

Globally stopped by

sponsor 2021

2019

DKN-01/atezolizumab as second line treatment of biliarY tract

cancer and in combiNAtion or not with paclitaxel as second or

third line treatMent of esophagogastrIC cancer: a multicenter

Phase II Trial-(DYNAMIC) -EORTC

Dr. Papanastasopoulos

Globally stopped by

Sponsor 2020

2021

Molecular characterization of rare cancers – (Arcagen) which falls under the platform “SPECTA”: Screening Cancer Patients for Efficient Clinical Trial Access-EORTC

Dr. Papamichael

2021