RecruitingPhase 2NCT05022030

First-line mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for Metastatic Left-sided CRC With Wild-type RAS/BRAF Genes

First-line Treatment of mCapOX Plus Cetuximab Versus mFOLFOX6 Plus Cetuximab for Metastatic Left-sided CRC Patients With Wild-type RAS/BRAF Genes: a Multicenter, Randomised, Phase 2 Study


Sponsor

West China Hospital

Enrollment

150 participants

Start Date

Jul 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy regimens — mCapOX and mFOLFOX6, both combined with cetuximab — as first-line treatment for metastatic colorectal cancer (cancer that has spread) on the left side of the colon, in patients whose tumors do not have RAS or BRAF mutations. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic colorectal cancer (adenocarcinoma) starting on the left side of the colon - Your tumor tests negative for RAS and BRAF mutations - You have measurable disease on scans - You have not had prior chemotherapy or targeted therapy for metastatic disease - Your physical health is good (ECOG performance score 0–1) **You may NOT be eligible if...** - Your tumor has RAS or BRAF mutations - You have previously received chemotherapy or targeted therapy for metastatic disease (prior adjuvant therapy that ended more than 12 months ago may be acceptable) - You have active infections, severe heart problems, or other significant medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmCapOX plus cetuximab

capecitabine 1000mg/m2 po bid d1-7+oxaliplatin ivgtt 85mg/m2 d1+cetuximab ivgtt 500mg/m2, q2w

DRUGmFOLFOX6 plus cetuximab

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


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT05022030


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