Randomized pilot study comparing safety of irinotecan+S-1(IRIS)+bevacizumab and mFOLFIRI+bevacizumab for metastatic colorectal cancer (T-CORE0702)
- Conditions
- 1st line or 2nd line therapy for unresectable colorectal cancer
- Registration Number
- JPRN-UMIN000000770
- Lead Sponsor
- PO T-CORE (Tohoku Clinical Oncology Research and Education Society)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
The exclusion criteria were previously abdominal radiotherapy; active double cancers, with complication of paralytic intestine, bowel obstraction (ileus), uncontrolled diabtes mellitus, uncontrolled hypertention, unstable angina pectoris, liver cirrhosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema; previous history of herpersensitivity against S-1; massive pleural or peritoneal effusion; diarrhea, uncontrolled peptic ulcer; current or previous (within one year) history of GI perforation; primary or metastatic brain tumor by image examination; current or previous (within one year) history of cerebrovascular attach; symptomatic or asymptomatic but treated heart disease; any surgical treatmentsincluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks (except for a CV-port procedure one week or more earlier) or aspiration biopsy within one week; bleeding tendency, coagulation abnormality; anti-platelets therapy (including aspirin and NSAIDS) for chronic inflammatory disease such as rheumatoid arthritis; irinotecan used pevious adjuvant chemotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety
- Secondary Outcome Measures
Name Time Method response rate and progression free survival (PFS)