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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: | NCT00286130 |
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
Condition | Intervention | Phase |
---|---|---|
Metastatic Colorectal Cancer |
Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 150 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | October 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Werner Scheithauer, MD | Dep. of Internal Medicine I, Medical University of Vienna |
Study ID Numbers: | CECOG/Core 1.2.001, EUDRACT number 2004-002391-42 |
Study First Received: | February 2, 2006 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00286130 |
Health Authority: | Austria: Federal Ministry for Health and Women |
metastatic colorectal cancer FOLFOX 6 FOLFIRI |
Digestive System Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases Irinotecan Leucovorin Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |