Colorectal liver metastasis CRLM, FOLFOX
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histlogically proven colorectal carcinoma. 2. Curatively resected metastatic liver tumors of colorectal cancer. 3. No extrahepatic metastasis. 4. Within 4-8 weeks from the date of liver resection. 5. Age >= 20 years, Age =1500/mm3 ii.Platelets>=100,000/mm3 iii.Hemoglobin >=9.0g/dL iv. Total bilirubin <=1.5g/dL v. AST, ALT, ALP <=2.5ULN vi. Creatinine<=1.5mg/dL 8. Checked chest and abdominal CT within 30 days. 9. Promised of more than 3 months survival 10.Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Neurologic symptom due to cerebrovascular diseases. 2. Cardiac diseases. 3. Uncontrollable hypertension, Uncontrollable diabetes. 4. Renal dysfunction. 5. Uncontrollable gastrointestinal ulcer 6. Prior hypersensitivity reaction to drugs used in this trial. 7. Suspected of DPD Deficiency. 8. Prior treatment with L-OHP within 6 months. 9. Treatment with MTX to RA. 10. Uncontrollable infectious diseases. 11. Uncontrollable diarrhea. 12. Neuropathy >= Grade2 according to the CTCAE. 13. Body fruid (ascites,pleural effusion.pericardiac effsion). 14. Multiple malignancies to be treated within 5 years. 15. Prior treatment with immunosuppressant and transplantation. 16. Pregnant. 17. Any other cases who are regarded as inadequate for study enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the completion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, relapse-free survival, 3-year relapse-free survival rate, adverse event, relative dose intensity, the correlation between the remnant liver ratio and the completion rate, change over time about sensory nerve disorder | — |
Contacts
Department of Surgery, Graduate School of Medi cine, Kyoto University