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Sponsored by: |
Central European Cooperative Oncology Group |
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Information provided by: | Central European Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT00479752 |
To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: FOLFOX4 (Oxaliplatin), Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 + Weekly Cetuximab Versus FOLFOX4+ Biweekly Cetuximab as First-Line Therapy in Patients With Metastatic Colorectal Cancer. |
Estimated Enrollment: | 150 |
Study Start Date: | June 2007 |
This multicenter randomized phase II study will enroll approximately 150 patients with metastatic Colorectal Cancer. Patients are randomized in Arm A(FOLFOX4 in combination with weekly Cetuximab) or Arm B (FOLFOX4 in combination with biweekly Cetuximab). Both efficacy and safety data will be collected. The investigator will assess response to treatment every 8 weeks based on the imaging.
Following permanent treatment cessation, patients will be followed-up for survival.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara Planko, Mag(FH) | 43 1 4097725 | barbara.planko@cecog.at |
Austria, Steiermark | |
LKH Leoben, Abt. für Innere Medizin | |
Leoben, Steiermark, Austria, 8700 | |
Bosnia and Herzegovina | |
Institute of Oncology Sarajevo | |
Sarajevo, Bosnia and Herzegovina | |
Bulgaria | |
SBALO National Oncology Center | |
Sofia, Bulgaria, 1754 | |
Croatia | |
Clinical Hospital Split, Center of Oncology | |
Split, Croatia | |
University Hospital for Tumors | |
Zagreb, Croatia | |
University Hospital Rebro | |
Zagreb, Croatia | |
University Hospital Centre Rijeka | |
Rijeka, Croatia, 51000 | |
Cyprus | |
Bank of Cyprus Oncology Center | |
Nikosia, Cyprus | |
Estonia | |
Noth estonian Regional Oncology Hospital | |
Tallin, Estonia, 13419 | |
Hungary | |
Markusovsy Hospital | |
Szomathely, Hungary, 39700 | |
National Medical Center | |
Budapest, Hungary, 1135 | |
Semmelweis Univ. Radiology Clinic | |
Budapest, Hungary, 1082 | |
Israel | |
Oncology Division Sourasky Medical Center | |
Tel Aviv, Israel, 64239 | |
Meir Medical Center | |
Kfar Saba, Israel | |
Latvia | |
latvian Center of Oncology | |
Riga, Latvia, 1079 | |
P. Stradins University Hospital | |
Riga, Latvia, 1020 | |
Romania | |
Institutul Oncologic Bucuresti | |
Bucuresti, Romania | |
Serbia and Montenegro | |
Institute of Oncology and Radiology of Serbia | |
Belgrade, Serbia and Montenegro, 11000 | |
Institute of Oncology of Vojvodina | |
Sremska Kamenica, Serbia and Montenegro, 21204 | |
Slovakia | |
National Cancer Institute | |
Bratislava, Slovakia, 83310 | |
National Institute of Oncology | |
Bratislava, Slovakia | |
Slovenia | |
Institute of Oncology | |
Ljubljana, Slovenia, 1000 |
Principal Investigator: | Tudor Ciuleanu, Prof. Dr. | Institutul Oncologic of Cluj |
Study ID Numbers: | CECOG /CORE 1.2.002 |
Study First Received: | May 25, 2007 |
Last Updated: | May 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00479752 |
Health Authority: | Austria: Federal Ministry for Health and Women |
Oxaliplatin Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |