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

ABSTRACT: 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

DISEASE(S): Colorectal Cancer

PROVIDER: 2611228 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR