NCT02836977

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

Objectives: 1. 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. 2. Secondary Objectives: * To assess 5-year overall survival (OS) in each arm * To assess the safety profiles Patient Selection and Enrollment: Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 2:1, to reach approximately 546 patients in total. Plan of the Study: 1. Study Design This is an open-label, randomized, comparative, double arm, multicenter study to assess disease free survival, overall survival, safety profiles with tegafur-uracil following adjuvant oxaliplatin-based regimen as maintenance for one-year in patients with stage III colon cancer after radical resection in Taiwan. 2. Subject Number Eligible patients will be randomized in 2 arms in the ratio of 2:1, to reach approximately 546 patients in total. 3. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB) Expected recruitment rate: 23 subjects/month Duration of recruitment: at least 2 years. Duration of the study: at least 5 years. 4. Visit Schedule The schedule of assessments (please refer section 8.4 for the details) indicates the number and timing of the planned visits, which must be maintained as accurately as possible. The visit schedule must be maintained as accurate as possible. 5. Duration of Treatment Treatment should be administered up to maximum one year, disease progression, intolerable toxicity, or consent withdrawal during any time of the study, the patient will be withdraw.

Conditions

• Stage III Colon Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-03-01
• Completion: 2024-02-29
• First posted: 2016-07-19
• Last updated: 2017-02-08

Locations

1 site across 1 country: Taiwan