The FIRE-3 trial is a multicenter randomized phase III trial investigating 5-FU, folinic acid and irinotecan (FOLFIRI) plus cetuximab versus FOLFIRI plus bevacizumab in first line treatment of metastatic colorectal cancer. Planned accrual is 284 evaluable patients per treatment arm. The primary study endpoint is objective response rate. Secondary endpoints are median progression free survival, median overall survival, safety, and secondary resection rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
568
5-FU 400 mg/m² Bolus day 1 5-FU 2400 mg/m² iv over 46 h day 1-2
Folinsäure (racemisch) 400 mg/m² iv, 120 min d 1
Irinotecan 180 mg/m² iv, 30 - 90 min day 1
Cetuximab initial 400mg/m² as 120 min infusion, than 250 mg/m² iv as 60 min infusion d 1 + 8
Bevacizumab 5 mg/kg iv over 30 to 90 minutes d 1
University of Munich - Klinikum Grosshadern
Munich, Germany
Objective response rate
Time frame: approximate 6 months after randomisation
Median progression free survival
Time frame: approximate 6 months after randomisation
Median overall survival
Time frame: approximate 3 years after randomisation
Secondary resection rate with curative intent
Time frame: up to 3 months after end of treatment
Safety and toxicity (according to NCI-CTCAE)
Time frame: approximate 6 months after randomisation
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