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Maintenance Tegafur-uracil Versus Observation Following Adjuvant Oxaliplatin-based Regimen in Patients With Stage III Colon Cancer After Radical Resection

NCT02836977 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2017-02-08

No results posted yet for this study

Summary

Primary Objective:

To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection.

Secondary Objectives:

* To assess 5-year overall survival (OS) in each arm
* To assess the safety profiles

Conditions

  • Stage III Colon Cancer

Interventions

DRUG

tegafur-uracil

Eligible patients will receive tegafur-uracil orally at a dose of 400mg/day (100mg/Cap., 2 capsules each time, twice a day) and folinic acid 30mg/day (15mg/Tab., 1 tablet each time, twice a day) for one year.

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-31
Completion
2024-02-29

Countries

  • Taiwan

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 NCT02836977 on ClinicalTrials.gov