Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
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
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
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
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
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
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
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