MedTrace Logo

The Efficacy and Safety of Modified XELOX(mXELOX) Plus Cetuximab vs FOLFOX Plus Cetuximab in RAS and BRAF WT mCRC Pts

NCT05074966 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2021-10-12

No results posted yet for this study

Summary

This is an open label, multicenter, randomized study in Chinese patients with RAS and BRAF wild-type mCRC. Participants were randomly assigned to cetuximab + FOLFOX (group A) and cetuximab + modified XELOX\[mXELOX\] (group B). All patients in groups A and B will be treated until progression of disease(PD), death, intolerable toxicity or withdrawal of informed consent, whichever occurs first.

Conditions

  • Colo-rectal Cancer

Interventions

DRUG

Experimental: mXELOX plus cetuximab

Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Cetuximab: 500 mg/m2, IV, d1, q2w; Oxaliplatin: 85 mg/m2, IV, d1,q2w; Capecitabine: 850 mg/m2, po, bid, q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w;

DRUG

Active Comparator: FOLFOX plus cetuximab

Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Oxaliplatin 85 mg/m2, IV d1; Leucovorin 400 mg/m2 IV d1; 5-FU 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion; q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Leucovorin： 400 mg/m2 IV d1, q2w; 5-FU： 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48hours) IV continuous infusion, q2w （Cetuximab combined with capecitabine can be used according to the patient's wishes and the nursing situation of intravenous catheterization）

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Aiping Zhou, Doctor · Cancer Hospital & Institute, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-06
Primary Completion
2024-06-24
Completion
2025-06-24

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074966 on ClinicalTrials.gov