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Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)

NCT03199989 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1254

Last updated 2020-03-06

No results posted yet for this study

Summary

The purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon cancer patients with high risk factors.Therefore the investigators can provide high level clinical evidence of indications for patients with colon cancer with stage II colon cancer.

Conditions

  • Adjuvant Chemotherapy

Interventions

DRUG

CapeOX（Capecitabine+Oxaliplatin）

Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months

OTHER

Observation

Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Aiwen Wu, M.D. · Peking University Cancer Hospital & Institute

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
2017-06-01
Primary Completion
2021-07-31
Completion
2024-07-31

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 NCT03199989 on ClinicalTrials.gov