Biliary Tract Cancer Clinical Trial
Official title:
Multicenter Phase II Study of Docetaxel and Oxaliplatin Combination in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
1. Goals
- The primary goal of this phase II trial is to:
evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin
in patients with locally advanced or metastatic BTC as first-line therapy
Secondary goals are to:evaluate the treatment-related toxicities of this combination,
investigate progression-free survival (PFS) and overall survival (OS) in this
population
2. Design
The proposed clinical trial is an open label, non-comparative, multicenter phase II trial
according to the two stage testing design by Simon.22
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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