Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating
FOLFIRI and mFOLFOX6 is more effective than biweekly cetuximab with continuously FOLFIRI in
patients with potential resectable KRAS wildtype metastatic colorectal cancer.
All patients will be randomized to biweekly cetuximab 500 mg/m2 in combination with arm A)
FOLFIRI (irinotecan 180 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46
hours 5FU infusion of 2400 mg/m2 every 2 weeks) or arm B) FOLFIRI alternating with FOLFOX6
(Oxaliplatin: 85 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU
infusion of 2400 mg/m2 every 2 weeks) .
Primary objective: response rate (RECIST 1.1) in patients with with potential resectable KRAS
wildtype metastatic colorectal cancer.
Secondary objectives: Resection rate, PFS, OS, Quality of life, tolerability. Biomarker
evaluation to measure plasma biomarkers, Tumour blocks and sequential serum and plasma will
be collected to search for markers that may predict efficacy including respectability and
safety.