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) + Bevacizumab as second line treatment in patients with KRAS mutant type unresectable advanced colorectal cancer (mCRC).
- Conditions
- metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000009318
- 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)History of serious drug hypersensitivity or a history of drug allergy 8)Pregnant or lactating woman 9)Requiring steroid drug 10)Receiving flucytosine, atazanavir sulfate 11)Uncontrollable diarrhea 12)Uncontrollable peptic ulcer 13)High-grade peritoneal metastasis and stricture 14)History of the perforation of the digestive tract within 6 months before registration 15)History of the thromboembolism, brain infarction, lung infarction, brain infarction or pneumonitis 16)Operation within 28 days 17)Congenital bleeding predisponency or abnormality of hemostasis 18)Patients have anticoagulant agent 19)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 PFS
- Secondary Outcome Measures
Name Time Method OS, TTF, RR, DCR, Safety, Dose-Intensity