This prospective, randomized, phase 2 study is conducted to evaluate the efficacy and safety of first line mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS and BRAF genes.
The patients, who meet the inclusion criteria and have signed the informed consent, will be randomly assigned (1:1 ratio) to receive mCapOX plus cetuximab regimen (arm A) and mFOLFOX6 plus cetuximab regimen (arm B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
capecitabine 1000mg/m2 po bid d1-7+oxaliplatin ivgtt 85mg/m2 d1+cetuximab ivgtt 500mg/m2, q2w
oxaliplatin ivgtt 85mg/m2 d1+ leucovorin ivgtt 400mg/m2 d1+ fluorouracil iv bolus 400mg/m2 d1+ fluorouracil 2400mg/m2 continuous infusion for 46h+cetuximab ivgtt 500mg/m2, q2w
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGProgression free survival (PFS) rate at 9 months
PFS rate at 9 months is defined as the proportion of patients without PD or death at 9 months after randomization.
Time frame: 9 months
Objective response rate
The rate of complete response and partial response
Time frame: 6 months
Disease control rate
The rate of complete response, partial response and stable disease.
Time frame: 6 months
Progression free survival
Progression free survival is defined as the period from randomization to disease progress or death.
Time frame: up to 3 years
Overall survival
Overall survial is defined as the period from randomization to death.
Time frame: up to 4 years
Adverse event rate
The rate of adverse event after treatment
Time frame: 3 years
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