To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000003935
- Lead Sponsor
- Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 48
Not provided
1) Treatment with tegafur gimestat otastat potassium Within 7 days 2)History of the serious hypersensitivity for Fluorouracil , Levofolinate calcium,platinum or bevacizumab 3) Active multiple Primary cancer within 5 years 4) History of adverse events related to DPD loss 5) Uncontrolled diarrhea 6) Any surgical treatments oncluding skin-open biopsy,trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 7)Complication of cerebrovascular disease or symptoms within 1 years 8) Administering antithrombotic drug within 10 days before enrollment 9)Need tobadministrate or having anti-plateles therapy(including Methotrexate aspirin and NSAIDS) 10)Evidence of bleeding diathesis or coagulopathy 11)Symptom of colorectal obstruction 12)uncontrolled complication of peptic ulcer 13)Current or previous (within the last 1 year) history of GI perforation 14)Renal failure to be treated,2+ or higher proteinuria within 2 weeks prior to entry 15)Uncontrolled Hypertension 16)Uncontrolled Infection 17)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers 18)Man who doesn't practice birth control 19)Treatment history of Oxlplatin 20)Other conditions not suitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression Free Survival Overall survival, 1-year survival rate Disease control rate Response time Safety Overall survival from first line Second progression free survival (Progression Free Survival from first line)Case who has bevacizumab treatment in Registered patient,