Colorectal Cancer Clinical Trial
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.
To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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