Currently recruiting trials and/or near future recruitment

Transcription

1 Clinical Trials at the Bank of Cyprus Oncology Centre (As of Jan 2018) Currently recruiting trials and/or near future recruitment Development of a module to supplement the EORTC Core instruments for assessment of Health Related Quality of Life in patients with Anal Cancer (phases I-IV) Screening Platform of the EORTC for Clinical Trials Advanced Colorectal cancer SPECTAcolor Creation of symptom based questionnaires based on current guidelines for module development: the development of a time-efficient procedure GIST EORTC (phases I-IV) 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 (phases I-IV) 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 2015 Development of an EORTC cancer survivorship quality of life questionnaire (Phase I-IV) 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 - BOCOC 2016 A Disease Registry Study To Prospectively Observe Treatment Patterns And Outcomes In Patients With Her2-Positive Unresectable Locally Advanced Or Metastatic Breast Cancer ROCHE HELLAS Dr. Marcou Dr. Kakouri 2017 Development of an EORTC quality of life questionnaire for patients with Pancreatic Neuroendocrine Tumors (P- Net): Phases I-III 2017 A Phase III, open-label, multicenter trial of avelumab (MSB C) versus platinum-based doublet as a first-line treatment of recurrent or Stage IV PD-L1+ nonsmall cell lung cancer - Merck KG Dr. Orfanos Dr. Kyriacou

2 Currently recruiting trials and/or near future recruitment cont A multi-centre randomised clinical trial of biomarkerdriven maintenance treatment for first-line metastatic colorectal cancer (MODUL) A Phase II study - ROCHE HELLAS Dr. Papanastasopoulos 2017 Development of an EORTC questionnaire for individuals at risk for a Hereditary Cancer Predisposition Syndrome: the EORTC QLQ-HCPS

3 New trials awaiting EC / RA approvals coming soon 2016 Magnetic Resonance Tumour Regression Grade (mrtrg) as a Novel Biomarker to Stratify Management of Good And Poor Responders to Chemotherapy: A Rectal Cancer Multicentre Randomised Control Trial Royal Marsden NHS Foundation Trust and Pelican cancer foundation Awaiting EC/ RA submission 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 2016 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 Awaiting for Site Initiation Visit Preparing EC/ RA submission 2017 Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma Dr. Constantinidou Awaiting EC response/ for RA submission

4 Older trials which are now 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 A randomised trial to assess the role of irinotecan and oxaliplatin in advanced colorectal cancer - focus-(mrc - Medical Research Council-Uk) FOCUS study 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 The international tirapazone triple trial 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 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) Dr. Adamou Dr. Kakouri 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) Dr. Adamou Dr. Kakouri 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. EORTC (8021)

5 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 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 ( ) pc199-eulint Prophylactic cranial irradiation in extensive disease small cell lung cancer EORTC ( ) 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 International, Randomized, Open-Label, Phase III Trial of Paclitaxel/Carboplatin plus PF versus Paclitaxel/Carboplatin alone as first-line treatment of patients with advanced non-small cell lung cancer. (A ) 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 EORTC ( ) Dr. Kitsios 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 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.

6 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 study International Validation Study of the European Organization for Research and Treatment of Cancer Brain Module (EORTC-QLQ-BN20) Quality of Life group measure with EORTC-QLQ-C30 for Assessing Quality of Life in Patients with Brain Metastases: A study conducted on behalf of the EORTC (Quality of Life Questionnaire BN20-C30) 2010 International Cross-Cultural Field Validation of an EORTC Questionnaire Module for Patients with Bone Metastases EORTC (QLQ-BM22) An open-label, randomized, controlled, multi-center, Phase 1/11 trial investigating 2 EMD 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 study. An International Field Study of the Reliability and Validity of an EORTC Older Person-Specific Quality of Life (QOL) Questionnaire Module (the EORTC QLQ-ELD15) and EORTC QLQ-C30 in assessing the QOL of cancer patients aged 70 years and above. EORTC (QLQ-ELD15 and QLQ-C30) A non-interventional follow-up to the MOSAIC study (multicentre international study of Oxaliplatin/5- Fluorouracil/Leucovorin in the adjuvant treatment of colon cancer) up to 10 years and translational research MOSAIC EXTENSION (C09-2) Double blind randomized phase III study of maintenance pazopanib versus placebo in NSCLC patients, non progressive after first line chemotherapy. MAPPING, an EORTC Lung Group study. BISphosphonates use in solid tumours. REGistry for collecting the impact of treatment of bone metastases from solid tumours Dr. Kitsios 2015

7 A phase I, open-label, multicentre, 3-period, fixed sequence study to investigate the effect of Vemurafenib on the pharmacokinetics of a single dose of Tizanidine (A CYP1A2 Substrate) in patients with BRAF V600 mutationpositive metastatic malignancy Dr. Orphanos 2015 A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self- administered subcutaneous Trastuzumab as therapy in patients with operable HER-2- positive early breast cancer [SafeHer Study] Dr. Marcou (for CY) Update of the EORTC Questionnaire for assessing the quality of life in lung cancer patients (EORTC. QLQ LC13)- (Phases I to IV) Dr. Vomvas Dr. Georgiou 2016 Μελέηη θάζης ΙΙ μιας ομάδας θεραπείας με aflibercept ως θεραπεία ζσνηήρηζης μεηά από πρώηης γραμμής θεραπεία με FOLFIRI ζε ζσνδσαζμό με aflibercept ζε αζθενείς με μεηαζηαηικό κολοορθικό καρκίνο (for CY) 2007 A two-arm phase II randomised trial of intermittent chemotherapy plus continuous cetuximab and of intermittent chemotherapy plus intermittent cetuximab in first line treatment of patients with K-ras-normal (wild-type) metastatic colorectal cancer. COIN-B study MRC CR Monitoring response to systemic and regional chemotherapy using dynamic contrast enhanced ultrasonography DCE-US. Evaluation of Possible surrogate response markers for efficacy and toxicity. Dr. Polyviou 2017

8 but patients on follow up or trial awaiting closing procedures (Colorectal Cancer Trial) - Is greater downstaging and tumour regression observed when surgery is delayed to 12 weeks after completion of Chemoradiotherapy vs 6 weeks? Follow - up 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. A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer (IMM ) A phase IV, postmarketing, open-label, extension (rollover) study of Vemurafenib in patients with BRAF V600 mutation-positive malignancies previously enrolled in an antecedent Vemurafenib protocol Dr. Orphanos Follow - up A Prospective, Multicenter, Randomized, Double Blind, Placebo controlled, 2-Parallel Groups, Phase 3 Study to compare the efficacy and safety of Masitinib in combination with Folfiri (Irinotecan, 5-Fluorouracil and Folinic Acid) to Placebo in combination with Folfiri In second line treatment of patients with Metastatic Colorectal Cancer 2017 Investigation of the Increasing Incidence Trends of Thyroid Cancer in Cyprus - BOCOC Dr. Frangos 2017 The impact of air pollution and the Mediterranean diet on lung cancer development in Cyprus - BOCOC