A Multinational, Randomized, Phase III Study of XELIRI with/without Bevacizumab versus FOLFIRI with/without Bevacizumab as Second-line Therapy in Patients with Metastatic Colorectal Cancer.
- Conditions
- Patients with 2nd-line treatment of mCRC
- Registration Number
- JPRN-UMIN000012263
- Lead Sponsor
- PO Epidemiological and Clinical Research Information Network (ECRIN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 600
Not provided
1)Contraindications of each protocol drugs 2)History of other malignancy with a disease-free survival<5 years 3)Radiological evidence of brain tumor or brain metastases 4)Active infection including hepatitis 5)Previous treatment with irinotecan hydrochloride 6)Pregnant or lactating females, and males and females unwilling to use contraception 7)Requires continuous treatment with systemic steroids 8)Psychiatric disability that would preclude study compliance 9)Otherwise determined by the investigator to be unsuitable for participation in the study <In case of combination with Bevacizumab> 10)Concurrent or recent (within 1 year before enrollment) gastrointestinal perforation 11)Unhealed wound, gastrointestinal ulcer, or traumatic fracture 12)Current or recent(within 1 year before enrollment)thromboembolism or cerebrovascular disease 13)Uncontrolled hypertension 14)Urine dipstick for proteinuria>+2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method