colorectal cancer
Conditions
Interventions
Group A (standard therapy group): Administration of 5 courses (6 months) of a schedule (consecutive administration method) in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer 2) Histological Stage IIB, IIIA, IIIB, IIIC located in colon and rectosigmoid 3) Curative resection with D2 or more lymph node dissection 4) Resection of histological curability A was performed 5) Performance status (ECOG) 0, 1 6) No prior chemotherapy and radiotherapy 7) Oral intake is possible 8) Sufficient organ functions a) WBC >= 3,000/mm3, <12,000/mm3 b) Neutrophil >=1,500/mm3 c) Hemoglobin >= 9.0g/dL d) Platelet >= 100,000/mm3 e) Total bilirubin < 1.5mg/dL f) AST, ALT < 100IU/L g) Serum creatinine < 1.5mg/dL 9) Chemotherapy will be started within 6 weeks from operation 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) active synchronous or metachronous malignancy other than carcinoma in situ 2) serious coexisting illness a; severe pulmonary dysfunction b; ileus or colon dysfunction c; uncontrolled diabetes mellitus d; liver cirrhosis e; uncontrolled hypertension f; history of myocardial infarction, unstable angina within 6 months prior to the registration 3) pregnant or nursing 4) severe mental disorders 5) not suitable for participating in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, incidence of adverse events | — |
Countries
Japan
Outcome results
None listed