A multicenter phase II trial of TS-1+oxaliplatin+panitumumab as first-line treatment in patients with kras-wild type unresectable advanced colorectal liver metastasis.
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000007236
- Lead Sponsor
- Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 2
Not provided
1) History of severe allergy 2) Administration contraindication of oxaliplatin, panitumumab, TS-1, or 5FU 3) Severe infectious disease 4) Severe complications (interstitial lung disease or pulmonary fibrosis, , kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension) 5) History of interstitial lung disease or pulmonary fibrosis 6) Severe heart failure or history of severe heart failure 7) Peripheral sensory 8) Wattery diarrhea 9) Massive pleural effusion or ascites 10) Gastrointestinal perforation or bleeding 11) Patient medicated with anticoagulant drugs (except for low-dose aspirin [less than 325mg/day]) 12) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 13) Pregnant or lactating women or women of childbearing potential, and no birth-control 14) Mechanical bowel obstruction 15) Active hepatitis type B 16) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RR: response rate
- Secondary Outcome Measures
Name Time Method OS: overall survival PFS: progression free survival treatment completion rate safety