Randomized study of hepatectomy+mFOLFOX6 vs. hepatectomy alone for liver metastasis of colorectal cancer (JCOG0603)
Phase 2
- Conditions
- Resected liver metastasis from colorectal cancer with curative intent
- Registration Number
- JPRN-UMIN000000653
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
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
- Primary Outcome Measures
Name Time Method Treatment compliance at 9 courses after beginning mFOLFOX6 (phaseII) Disease-free survival (phaseIII)
- Secondary Outcome Measures
Name Time Method Overall survival, Incidence of adverse events, mode of recurrence