Spots Global Cancer Trial Database for Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
Official Title: A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
Study ID: NCT00286130
Conditions
Study Description
Brief Summary: In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
Detailed Description: The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC. EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively. Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
LKH Leoben, Abt. für Innere Medizin, Leoben, Steiermark, Austria
Univ. Klinik für Innere Medizin I, Wien, , Austria
Institute of Oncology, Sarajevo, , Bosnia and Herzegovina
University Hospital "Queen Joanna", Sofia, , Bulgaria
SBALO National Oncology Center, Sofia, , Bulgaria
University Hospital for Tumors, Zagreb, , Croatia
University Hospital Rebro, Zagreb, , Croatia
Bank of Cyprus Oncology Center, Nikosia, , Cyprus
Univ. Hospital Brno, Dept. Of Clinical Oncology, Brno, , Czech Republic
Charles University Prague, Dep. of Oncology, Prague, , Czech Republic
National Medical Center, Budapest, , Hungary
Markusovsy Hospital, Szomathely, , Hungary
Csolnoky Ferenc County Hospital, Veszprem, , Hungary
Hadassah Medical Center, Jerusalem, , Israel
Souraski Medical Center, Tel Aviv, , Israel
Hospital Amadora Sintra, Servico de Oncologia, Amadora, , Portugal
Hospital de Beja, Beja, , Portugal
Hospital Distrital de Faro, Faro, , Portugal
Hospital Geral de Sto. António, Porto, , Portugal
Hospital San Teotóno -, Viseu, , Portugal
Institutul Oncologic Bucuresti, Bucuresti, , Romania
Institutul Oncologic Cluj, Cluj-Napoca, , Romania
National Cancer Institute, Bratislava, , Slovakia
Institute of Oncology, Ljubljana, , Slovenia
Ankara Hacettepe University, Oncology Unit, Ankara, , Turkey
Gazi University Medical Faculty, Ankara, , Turkey
9 Eyul University Medical Faculty, Dep of Oncology, Izmir, , Turkey
Contact Details
Name: Werner Scheithauer, MD
Affiliation: Dep. of Internal Medicine I, Medical University of Vienna
Role: PRINCIPAL_INVESTIGATOR
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