EXIBIT: Oxaliplatin in Biliary Tract Cancer
The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria.
Secondary objectives are : Progression free survival, overall survival and safety.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin (GEMOX) in Patients With Biliary Tract Cancer|
- To evaluate response rate according to RECIST criteria
- To evaluate the progression-free survival in the ITT population
- To investigate safety using NCI-CTC criteria version 2
|Study Start Date:||April 2003|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174564
|Study Director:||Jean-Philippe Aussel||Sanofi|