Phase III Trial of Gemcitabine, Curcumin and Celebrex in Patients With Metastatic Colon Cancer
The primary end point of the study is time to tumor progression. The study is designed to
detect increase in median time to tumor progression from 2.7 months to 4.0 months, with 80%
power at a significance level of 5%. This requires approximately 100 patients. The median
time to tumor progression of 2.7 months was found in the Investigational New Drug (IND)
treatment program for gemcitabine, which enrolled 3023 patients with locally advanced or
metastatic colon cance
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Arie Figer, MD
Principal Investigator
Tel-Aviv Sourasky Medical Center
Israel: The Israel National Institute for Health Policy Research and Health Services Research
tasmc-05-na-05160-ctil
NCT00295035
March 2006
March 2007
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