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Cetuximab Plus Capecitabine as Maintenance Treatment in RAS and BRAF wt Metastatic Colorectal Cancer — C-CLASSIC  

Colorectal Cancer Clinical Trial

Official title:
A Phase III, Multicenter, Open-label, Randomized Study to Assess the Efficacy and Safety of Cetuximab Plus Capecitabine Versus Cetuximab as Maintenance Treatment Following First-line Induction Treatment With FOLFOX and Cetuximab in Chinese Patients With RAS and BRAF Wild-type Metastatic Colorectal Cancer

Clinical Trial Summary

This is an open-label, multicenter, randomized study to be conducted in Chinese patients with RAS and BRAF wild-type mCRC. Patients who have already completed 9 cycles of standard first-line induction treatment, without discontinuation for toxicity, of cetuximab or fluorouracil or oxaliplatin,, and achieved disease control (including CR/PR and SD), and are progression free at the end of Cycle 9 will be assigned to 2 maintenance treatment groups by randomization in a 1:1 ratio to receive cetuximab + capecitabine (Arm A) or cetuximab alone (Arm B). The randomization will be stratified by induction treatment response (complete response [CR]+ partial response [PR] versus stable disease [SD]) and primary tumor location (left side only versus right side). All patients from Arm A and Arm B will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal (whichever occurs earlier).

Clinical Trial Description

Coz COVID-19 limited, C-CLASSIC was terminated recruitment on 31Dec2022. Total screen 100 subjects and enroll 80 subjects. All subjects in study will be treatment until meet study endpoint. Then study related subject follow up, data collect, clinical study report will be continued as planned. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04262635
Study type Interventional
Source Sun Yat-sen University
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 24, 2021
Completion date August 30, 2024
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