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Cetuximab Maintenance Treatment Versus Continuation After Induction Therapy in mCRC

NCT02942706 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-04-30

No results posted yet for this study

Summary

This study is try to evaluate the effect of cetuximab monotherapy as maintenance treatment, versus continuation after 8 courses of induction therapy with cetuximab plus standard chemotherapy regimen (FOLFIRI or mFOLFOX6）in metastatic colorectal cancer (mCRC) patients. The maintenance treatments are continued until disease progression or untolerated toxicity. The aim of this study is to demonstrate that cetuximab monotherapy is non-inferior to continuation treatment, in those mCRC patients who responded to induction therapy(SD, PR, or CR), and carry biomarker-panels (KRAS, NRAS, BRAF, and PIK3CA) favor EGFR antibody.

Conditions

Interventions

DRUG

Cetuximab

anti-EGFR monoclonal antibody

DRUG

mFOLFOX6

Oxaliplatin+LV5FU2

DRUG

FOLFIRI

Irinotecan+LV5FU2

Sponsors & Collaborators

  • Chinese PLA General Hospital

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Jun Zhang, MD & Ph.D · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-10-31
Completion
2022-10-31

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Entities

Drugs
Diseases

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 NCT02942706 on ClinicalTrials.gov