Clinical Trial: Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

Brief Summary:

Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a phase III clinical study, cisplatin plus gemcitabine is considered standard first-line treatment in advanced cholangiocarcinoma patients, but there is no established second line therapy.

Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could be an effective second-line treatment for patients with advanced cholangiocarcinoma.


Detailed Summary:
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Current Primary Outcome:

  • pilot study: toxicity [ Time Frame: 24 weeks ]
    number of adverse events in accordance with CTCAEv4.0
  • phase II: the response rate [ Time Frame: 24 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • pilot study: the response rate [ Time Frame: 24 weeks ]
  • pilot study: time to progression. [ Time Frame: 24 weeks ]
  • pilot study: the overall survival [ Time Frame: 24 weeks ]
  • pilot study: quality of life [ Time Frame: 24 weeks ]
  • phase II: toxicity during the treatment period and 30 days after the treatment. [ Time Frame: 24 weeks ]
    number of adverse events in accordance with CTCAEv4.0
  • phase II: time to progression. [ Time Frame: 24 weeks ]
  • phase II: the overall survival. [ Time Frame: 24 weeks ]
  • phase II: quality of life [ Time Frame: 24 weeks ]


Original Secondary Outcome: Same as current

Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: March 10, 2015
Date Started: December 2015
Date Completion: January 2018
Last Updated: February 11, 2016
Last Verified: February 2016