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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
173
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Sydvestjysk Hospital
Esbjerg, Denmark
Herlev University Hospital
Herlev, Denmark
Herning Hospital
Herning, Denmark
Naestved Hospital
Næstved, Denmark
Odense University Hospital
Odense, Denmark
Roskilde Hospital
Roskilde, Denmark
Haukeland University Hospital
Bergen, Norway
...and 2 more locations
Response rate (RR)
Time frame: March 2015 (up to 3 years)
Survival (Overall survival)
Time frame: June 2016 (up to 5 years)
Frequency of secondary surgical resection (R0 + R1 + R2 resections)
Time frame: January 2015 (up to 3 years)
Frequency of secondary micro-radical surgical resection (R0 resection)
Time frame: March 2015 (up to 3 years)
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