Biliary Tract Cancer Clinical Trial
Official title:
Multicenter Phase II Study of Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) 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 Fluorouracil, Leucovorin,
Oxaliplatin, and Irinotecan in patients with locally advanced or metastatic Biliary
tract cancer as first-line chemotherapy
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 two-stage testing procedure
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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