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
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
the percentage of patients surviving without disease progression in each arm at 9 months
Werner Scheithauer, MD
Dep. of Internal Medicine I, Medical University of Vienna
Austria: Federal Ministry for Health and Women