colorectal liver metastases
Conditions
Interventions
Sponsors
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)liver metastasis is histologically diagnosed as colorectal cancer. 2)Curative resection is performed for primary tumors and liver metastasis 3)Primary liver resecion and recurrent liver resection 4)There are no distant metastasis, recurrences except the liver. 5)There is no history of thermocoagulation therapy and cryotherapy for livermetastasis. 6)The age is between 20 years old and 80years old at the registration day. 7)Performance status is 0-2 cases. 8)A major organ function is maintained by a laboratory study within 14 days before registration. 9)The oral intake of the drug is possible. 10)Treatment can start within eight weeks after an operation. 11)An agreement is obtained in a document from the patients
Exclusion criteria
Exclusion criteria: 1)Surgical stump was clearly positive. 2)Case with the history of usage of S-1 or the L-OHP 3)Multiple primary cancer 4)Serious postoperative complications 5)Case with the following complications -In insulin therapy or diabetes mellitus inadequate control -Poor control hypertension (systolic blood pressure more than 180mmHg) -Heart failure within six months, myocardial infarction, angina and remarkable electrocardiogram abnormal. -Severe liver disease -Severe renal disease -Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema 5)Active infection 6)Peripheral sensory nerve disorder 7)Peripheral sensory nerve disorder 8)Previous serious drug hypersensitivity 9)The case that uses flucytosine, phenytoin, warfarin potassium 10)A pregnant woman or the women who may be pregnant. Men in hope of the pregnancy of the partner. 11)The patients complicated with psychosis or neurologic manifestation, and judged to have difficulty in participation in clinical trials 12)The case judged to be unsuitable for registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease free survival | — |
Countries
Japan
Outcome results
None listed