JCOG0603: Randomized study of hepatectomy+mFOLFOX6 vs. hepatectomy alone for liver metastasis of colorectal cancer

Phase 2

• Conditions: Resected liver metastasis from colorectal cancer with curative intent

• Registration Number: JPRN-jRCTs031180285
• Lead Sponsor: KANEMITSU Yukihide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1) Histologically confirmed liver metastasis of colorectal cancer
2) R0 after resection of both primary and seccondary lesions
3) No extrahepatic disease
4) No prior chemotherapy or radiotherapy
5) No prior radiofrequency ablation or cryotherapy for liver metastasis
6) At 42 to 70 days after hepatectomy
7) Patient age is more than 20 and less than 75
8) PS: 0, 1
9) Organ function is kept
10) Written informed consent

Exclusion Criteria

1) Multiple cancer patients
2) Pregnant patients
3) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
4) Psychological disorder
5) Steroid administration
6) Patients must use flucytosine, phenytoin or wargarin potassium
7) Insulin dependent or uncontrollable diabetes mellitus
8) Diarrhea or peripheral neuropathy greater than grade 1
9) Uncontrollable hypertension
10) Unstable angina pectoris, or history of myocardial infarction within six months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified