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

Stage III Colon Cancer Clinical Trial

Status Active, not recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Colonic Neoplasms
• Stage III Colon Cancer

• NCT number: NCT02836977
• Study type: Interventional
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2016
• Completion date: February 29, 2024