Colon cancer
Conditions
Interventions
Capecitabine (Xeloda) is administered orally as tablets, 1250 mg/m2 twice daily for 14 days followed by a 7-days resting period without treatment, as an intermittent therapy in a 3-weeks cycle for 8 t
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed Colorectal adenocarcinoma 2) Histological Stage III Colon, Rectosigmoid cancer 3) Curative resection with D2 or more lymph node dissection 4) Resection of histological curability A was performed 5) Performance status(ECOG): 0 or 1 6) No prior chemotherapy and radiotherapy 7) Oral intake is possible 8) Sufficient organ functions WBC >= 3,000/mm3, <12,000/mm3 Hemoglobin >= 9.0g/dL Platelet >= 90,000/mm3 Serum creatinine <= 1.5xULN Total bilirubin <= 1.5 xULN AST,ALT <= 2.5xULN ALP <= 2.5xULN 9) Creatinine clearance >50mL/min 10) Chemotherapy will be started within 8 weeks from operation 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Pregnant or nursing 2) Medical history of allergy or hypersensitivity reactions to fluoropyrimidines 3) The past of the internal organ transplant 4) 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 5) Active synchronous or metachronous malignancy other than carcinoma in situ 6) Uncontrollable infectious disease 7) Not suitable for participating in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival, Overall survival, 2-year disease-free survival rate, Adverse events, Individual dose intensity, Health related quality of life, Pharmacoeconomics | — |
Countries
Japan
Outcome results
None listed