Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab
Phase 2
Recruiting
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000009734
- Lead Sponsor
- 3rd department of surgery Tokyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
1) With contraindicate S-1 2) Patients under treatment with flucytosine,phenytoin,warfarin potassium. 3) Severe bone marrow suppression 4) Active infection and inflammation 5)Comorbidity or history of interstitial lung disease or pulmonary fibrosis 6) Watery stools or diarrhea 7) Severe complications 8)Simultaneous or metachronous double cancers 9)Pregnant or lactating women or women of childbearing potential 10) Other patients who are unfit for the study as determined by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival(PFS)
- Secondary Outcome Measures
Name Time Method Overall response rate Overall survival Disease control rate (CR+PR+SD) Safety