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:

  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

Detailed Summary:
Sponsor: Soon Chun Hyang University

Current Primary Outcome: Response rate [ Time Frame: 2 years ]

Assessment of response will be assessed according to RECIST v1.1 criteria after completion of every two cycles. Evaluation will be conducted by physical examination, X-ray, or CT scan


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