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

• Status: Active, not recruiting
• Trial end date: 2024-02-29
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Treatments: Oxaliplatin; Tegafur

Criteria

Inclusion Criteria:

To be eligible for inclusion, each subject must fulfill all of the following criteria:

1. pathologically confirmed colon carcinoma;

2. stage III disease (T1-4, N1-2, M0 as defined by AJCC 7th Edi.);

3. completion of adjuvant oxaliplatin-based regimen without evidence of any recurrent disease;

4. entry of the trial within 3 weeks after adjuvant oxaliplatin-based regimen;

5. performance status of ECOG 0, 1, 2;

6. age between 20 and 80 years old;

7. written informed consent to participate in the trial.

Exclusion Criteria:

Patients who fulfill any of the following criteria will be excluded from the trial:

1. previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years;

2. inadequate hematopoietic function defined as below:

1. hemoglobin < 9 g/dL;

2. absolute neutrophil count (ANC) < 1,500/mm3;

3. platelet count < 100,000/mm3;

3. inadequate organ functions defined as below:

1. total bilirubin > 2 times upper limit of normal (ULN);

2. hepatic transaminases (ALT and AST) > 2.5 x ULN;

3. creatinine > 1.5 x ULN;

4. other significant medical conditions that are contraindicated to tegafur-uracil or render patient at high risk from treatment complications based on investigator's discretion;

5. presence of other serious concomitant illness;

6. participation in another clinical trial with any investigational drug within 30 days prior to entry;

7. pregnant or lactating women or women of childbearing potential.