Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
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