An exploratory study of treatment sensitivity and prognostic factors in a efficacy and safety study of mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naive unresectable advanced or recurrent colorectal cancer

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): exploratory
Overall survival (OS)
Timeframe: Up to approximately 63 months
OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes.
Study Design: Exploratory analysis