A Phase II trial of irinotecan / S-1 (IRIS) + alfa (Panitumumab/Bevacizumab) as 2nd line chemotherapy for metastatic colorectal cancer (mCRC) A multicenter phase II trial of TS1 + Irinotecan (IRIS) + Panitumumab as second line treatment in patients with KRAS wild type unresectable advanced colorectal cancer (mCRC).
- Conditions
- metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000009317
- Lead Sponsor
- Yamaguchi University Department of Digestive Surgery and Surgical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1)Presence of active multiple primaries. Active multiple primaries is simultaneous or metachronous with disease-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded. 2)Massive pleural effusion or ascites that required drainage 3)Symptomatic brain meta 4)Severe psychiatric disease or psychiatric symptoms 5)Severe complications 6)Undertook radiation therapy for abdominal lesions. 7)Operation within 28 days 8)History of serious drug hypersensitivity or a history of drug allergy 9)Pregnant or lactating woman 10)Requiring steroid drug 11)Receiving flucytosine, atazanavir sulfate 12)Uncontrolled diarrhea 13)Not appropriate for the study at the physician's assessment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RR
- Secondary Outcome Measures
Name Time Method OS, PFS, TTF, DCR, Safety, Dose-Intensity