Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (PARADIGM study)

Intervention name : mFOLFOX6 + panitumumab
INN of the intervention : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab
Dosage And administration of the intervention : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks
Control intervention name : mFOLFOX6 + bevacizumab
INN of the control intervention : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab
Dosage And administration of the control intervention : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks
Primary outcome(s): efficacy
Overall survival (OS) for All Participants
Timeframe: Up to approximately 63 months
OS will be measured as the time from the date of randomization to the date of death due to any cause.
efficacy
OS for Participants with Left-sided Tumors
Timeframe: Up to approximately 63 months
OS will be measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum.
Study Design: Randomized controlled trial, open, active control, parallel assignment