colorectal cancer
Conditions
Interventions
Group A (standard therapy group:UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed
Sponsors
Gunma University Graduate School of Medicine Department of Thoracic and Visceral Organ Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically proven colorectal cancer. 2.StageII high risk/III colon cancer(C, A, T, D, S), rectal cancer(RS, Ra). 3.Curability A 4.Age between 20 and 80 years. 5.No prior chemotherapy or radiation. 6.Patients who could measure preoperative lymphocyte ratio. 7.Performance status of 0-1. 8.Patients who have satisfied the following the clinical test values within two weeks before the registration. 1)WBC:>= 3,000/mm3, <12,000/mm3 2)Neutrophile:>= 1,500/mm3 3)Hemoglobin:>= 9.0g/dL 4)Platelet:>= 100,000/mm3 5)AST(GOT),ALT(GPT): = <100IU/L 6)Total bilirubin: = < 2.0 mg/dL 7)Serum creatinine: =<1.5mg/dL 9.Patient with starting the treatment within 8 weeks after operation. 10.Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Synchronous or metachronous colorectal cancer. 2.Severe infectious disease. 3.Severe postoperative complications. 4.Patients with following complications. 1)Uncontrolled diabetes or hyperpiesia. 2)Myocardial infarction within the past 6 months or unstable angina pectoris. 3)Hepatic cirrhosis , interstitial pneumonia , lung fibrosis, advanced pneumonectasia 5.Patients with diarrhea more than 3 times/day. 6.Active synchronous or metachronous malignancy carcinoma in situ. 7.Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period 8.Not suitable for participating in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year desease free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival time Adverse event rate Completion rate | — |
Countries
Japan
Contacts
Public ContactHiroomi OGAWA
Gunma University Graduate School of Medicine Department of Thoracic and Visceral Organ Surgery
Outcome results
None listed