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Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis

NCT03031444 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2021-02-01

No results posted yet for this study

Summary

This study was designed to analyze the prognosis and recurrence predictive factors of high risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.

The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared for these patients.

Conditions

  • Colorectal Cancer Stage IV
  • Metastasis

Interventions

DRUG

Cetuximab plus FOLFIRI/FOLFOX

cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy

DRUG

FOLFIRI/FOLFOX/CapeOX

to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)

Sponsors & Collaborators

  • Beijing Municipal Administration of Hospitals

    collaborator OTHER_GOV

  • West China Hospital

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • First Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Baocai Xing, MD · Beijing Cancer Hospital,Peking University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • China

Study Locations

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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 NCT03031444 on ClinicalTrials.gov