A Randomized Prospective Study Comparing Three Regimens of Oxaliplatin Plus Fluoropyrimidine and Avastin for Evaluation of Safety and Tolerability in First-line Treatment of Patients With Advanced Colorectal Cancer.

简要总结

主要结局

次要结局

• Actual treatment administration as characterized by median, mean, and range of doses given; dose modifications, omissions, and delays; and actual and relative dose intensity (TREE1 and TREE2)
• Tumor response rate (overall and confirmed) based on application of the Response Evaluation Criteria in Solid Tumors (RECIST) (TREE1 and TREE2)
• Time to treatment failure (TTF) (TREE1 and TREE2)
• Time to tumor progression (TTP) (TREE1 and TREE2)
• Median survival (TREE1 and TREE2)
• STUDY DESIGN
• A randomized, controlled, open-label multicenter trial to assess the safety & efficacy of 3 oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) +Avastin (TREE1 & TREE2) as first line therapy of advanced metastatic colorectal cancer
• The overall incidence of grade 3 and grade 4 adverse events during the first 12 weeks of treatment for each of the oxaliplatin-fluoropyrimidine regimens used without bevacizumab (TREE1)
• Type, frequency, severity, timing, and relatedness of all adverse events during treatment and for 30 days following discontinuation of treatment for each of the oxaliplatin-fluoropyrimidine regimens when used with or without bevacizumab(TREE1 and TREE2)
• Patients enrolled prior to the initiation of Amendment 3 (TREE1) will not be eligible to receive Avastin as a component of their treatment regimen.