Clinical Trial: Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Multicenter Phase II Study of Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) in Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Brief Summary:
-
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
- 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
Detailed Summary:
Sponsor: Soon Chun Hyang University
Current Primary Outcome: Response rate [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Treatment-related toxicities [ Time Frame: 2 years ]Assessment of toxicity will be assessed according to NCI CTCAE version 4.0.
- Progression free survival [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Soon Chun Hyang University
Dates:
Date Received: December 13, 2011
Date Started: October 2011
Date Completion: December 2013
Last Updated: December 14, 2011
Last Verified: December 2011