Colon cancer
Conditions
Interventions
Capecitabine treatment group Group A (capecitabine group) Protocol treatment starts within 6 weeks after surgery. Capecitabine is administrated dosage corresponding body surface area twice a day (wi
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 stage IIIa, IIIb primary colon cancer (not including RS) (Japanese Classification of Colorectal cancer 7th Ehition). 2.R0, R1. 3.No prior cancer treatment (radiationtherapy, chemotherapy, immunotherapy) before surgery. 4.Age between 20 and 80 years. 5.Performance status of 0-1. 6.Restriction about combined medicine, combination therapy: Chemotherapeutic agent, immunotherapeutic agent or radiation therapy that may effect on this study's result is not combined in principle, except for metastasis or relapse. 7.Organ functions (clinical test value): within 2 weeks before enrollment. White blood cell count: >= 4,000/mm3 and <12,000/mm3 Neutrophil count (ANC): >= 2,000/mm3 Blood platelet count: >= 90,000 /mm3 Hemoglobin: >= 9.0g/dl Serum GOT and GPT: <100IU/L Serum total bilirubin: <2.0mg/dl Serum creatinine: <= 1.5mg/dL 8.Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Synchronous or metachronous colorectal cancer. 2.History of hypersensitivity for capecitabine drug product component or fluorouracil. 3.Patients who need continuing use of warfarin potassium and phenytoin. 4.History of serious drug allergy (>= grade 3). 5.Patients with severe complication (such as ileus, interstitial lung disease, lung fibrosis, diabetes that is difficult to control, heart failure, renal failure, liver failure). 6.Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period 7.No birth-control. 8.HIV positive. 9.Not suitable for participating in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 years disease free survival, 3 years relapse free survival, 3 years overall survival, compliance, QOL | — |
Countries
Japan
Contacts
Public ContactOsamu TOTSUKA
Gunma University Graduate School of Medicine Department of Thoracic and Visceral Organ Surgery
Outcome results
None listed