OFT trial

Not Applicable

• Conditions: Colorectal liver metastasis; CRLM, FOLFOX

• Registration Number: JPRN-jRCT1051190106
• Lead Sponsor: Hatano Etsuro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-13
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

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 <= 80 years 6. The Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1 7. Cases that meet all the following criteria (Check all items using the test values of the latest within 14 days prior to entry). i.Neutrophil count >=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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified