Multicenter phase II trial of mFOLFOX6 with cetuximab as active chemotherapy regimen for liver metastases inappropriate for curative resection in EGFR positive and KRAS wild type colorectal cancer
- Conditions
- EGFR positive and KRAS wild type colorectal cancer with liver metastases inappropriate for curative resection
- Registration Number
- JPRN-UMIN000004683
- Lead Sponsor
- Tohoku - Six Universities Research Group by Experts (T-SURGE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
(1) Uncontrolled extrahepatic lesion (2) Symptomatic brain metastasis (3) Cardiac disease (over Grade 2 by CTCAE v4.0), or myocardial infarction within 1 year (4) Past or current history (within 5 years) of malignant disease, except for the early cancer healed clearly (5) Interstitial lung disease, or pulmonary fibrosis (6) Serious infectious disease (7) Serious complication (kidney failure, liver failure , hypertension, etc) (8) Peripheral neuropathy (over Grade 1 by CTCAE v4.0) (9) No willing of birth-control. Or pregnant or lactating women (10) Serious drug hypersensitivity or history of drug allergy of Fluorouracil, Levofolinate calcium and/or Oxaliplatin (11) Participation in other clinical trial within 4 weeks (12) History of serious drug hypersensitivity (13) Previously received on anti-EGFR antibody (14) Case whom investigator deny the enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 resection rate (Curative resection rate)
- Secondary Outcome Measures
Name Time Method Resection rate of liver metastases, Tumor response rate, Adverse events