A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.

A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer. - A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009725

Enrollment

Registered

2013-01-15

Start date

2012-11-01

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 cancer

Interventions

Pre-operative chemotherapy(mFOLFOX6) 4cycles followed by surgical hepatectomy followed by post-operative chemotherapy (mFOLFOX6) 8cycles, mFOLFOX6(L-OHP85mg/m2, Levofolinate200mg/m2, 5-FU/bolus400mg/m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histologically proven colorectal cancer 2. With measurable lesions in the liver only (no extrahepatic disease) 3. Resectable synchronous and metachronous liver metastases 4. No prior chemotherapy for colorectal cancer 5. No prior radiotherapy for colorectal cancer 6. Performance status(ECOG):0, 1 7. Life expectancy of more than 3 months 8. Sufficient organ functions 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Serious drug hypersensitivity or a history of drug allergy 2. Peripheral neuropathy 3. Active concomitant malignancy 4. Severe infectious disease 5. Serious complications (renal failure or hepatic failure) 6. High blood pressure and diabetic and hypercalcemia that cannot be controlled 7. Symptomatic or asymptomatic but treated heart disease 8. Symptomatic or asymptomatic but treated heart disease 9. Histry of mental disturbances or cerebrovascular attack 10. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 11. Plerral effusion, peritoneal fluid and pericardial fluid 12. Symptomatic brain metastasis 13. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 14. Under coutinuous steroid therapy 15. History of organ transplantation 16. Traumatic gracture of unrecovery 17. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 18. Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Liver resection rate	—

Countries

Japan

Contacts

Public ContactKenji Katsumata

Tokyo Medical University department of gastrointestinal and pediatric surgery

k-katsu@tokyo-med.ac.jp0333426111

Outcome results

None listed

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