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

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.