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

Interventions: investigational material(s)
Generic name etc : mFOLFOX6 + panitumumab
INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 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 material(s)
Generic name etc : mFOLFOX6 + bevacizumab
INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 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): 1.Overall survival (OS) for All Participants
Timeframe: Up to approximately 60 months
OS will be measured as the time from the date of randomization to the date of death due to any cause.
2.OS for Participants with Left-sided Tumors
Timeframe: Up to approximately 60 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