Safety and efficacy of postoperative adjuvant chemotherapy with L-OHP base regimen followed by UFT plus LV for resectable liver metastases from colorectal cancer

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020631

Enrollment

Registered

2016-01-31

Start date

2016-01-31

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

resectable liver metastases from colorectal cancer

Interventions

Postoperative adjuvant chemotherapy with L-OHP base regimen (6courses of mFOLFOX6 or 4courses of CapeOX) followed by 3courses of UFT plus LV.

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 <= 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

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	—

Countries

Japan

Contacts

Public ContactRei Toda

Kyoto University Hospital Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation

rtoda@kuhp.kyoto-u.ac.jp075-751-3608

Outcome results

None listed

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