Randomized phase III trial of surgery followed by mFOLFOX6 as adjuvant chemotherapy versus peri-operative mFOLFOX6 plus cetuximab for KRAS wild type resectable liver metastases of colorectal cancer
Phase 3
- Conditions
- Resectable colorectal liver metastases
- Registration Number
- JPRN-UMIN000007787
- Lead Sponsor
- Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Extrahepatic metastases or history of extrahepatic metastases (2) Metachronous 1 liver metastasis (3) More than 9 liver metastases (4) Prior local therapy for liver metastases (5) Severe comorbidity (6) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (7) Severe infectious disease (8) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding . Women with a positive pregnancy test (9) Psychological disorder (10) Considered not appropriate for surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival, Disease free survival, Safety, Postoperative complications, R0 rate, Liver resectability, Response rate