Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer(WJOG9216G)
Phase 2
- Conditions
- first-line treatment in patients with metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000026527
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
1) Serious complications. 2) Receipt of a blood transfusion or hematopoietic factor therapy within 2 weeks prior to registration. 3) Grade >=2 peripheral sensory neuropathy. 4) History of Grade >=3 thromboembolism within 6 months before the scheduled treatment start date. 5) Receiving anti-platelet agents. Aspirin use at doses up to 325 mg/day is permitted. 6) Women who are pregnant, breastfeeding, had a positive pregnancy test, or women and men who do not wish to use contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Overall survival,progression-free survival,time to treatment failure, time to second progression or death, early tumor shrinkage, depth of response, R0 resection rate, and safety