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LOFT trial

Safety and efficacy of postoperative adjuvant chemotherapy with L-OHP base regimen followed by UFT plus LV for resectable liver metastases fro m colorectal cancer. (LOFT trial ) - LOFT trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051190106
Enrollment
50
Registered
2020-02-13
Start date
2020-02-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal liver metastasis CRLM, FOLFOX

Interventions

Sponsors

Hatano Etsuro
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
the completion rate

Secondary

MeasureTime 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

Public ContactRei Toda

Department of Surgery, Graduate School of Medi cine, Kyoto University

rtoda@kuhp.kyoto-u.ac.jp+81-75-751-4323

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026