Clinical Trial: GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer

Brief Summary: To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.

Detailed Summary: Gemcitabine/cisplatin combination therapy (GC) has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). Investigators have evaluated the efficacy and safety of gemcitabine/cisplatin/S-1 combination therapy (GCS) for patients with advanced BTC and observed the promising efficacy. In this randomized phase Ⅲ study, investigators aimed to compare GCS with GC in patients with advanced BTC.
Sponsor: Kansai Hepatobiliary Oncology Group

Current Primary Outcome: Overall survival rate [ Time Frame: Probability of 1-year survival (%) ]

The primary endpoint is designated to evaluate overall survival rate at 12-month.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response rate [ Time Frame: Every 3 months, up to 24 months ]
    The investigators will conduct CT test every 3 months in order to measure the tumor size of each patient and evaluate the best tumor response according to RECIST criteria.
  • Progression free survival [ Time Frame: Every 3 months, up to 24 months ]
    In oredr to research the progression survival, the investigators will check the presence of progression disease for each patient every three months.
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 24 months ]
    The investigators will examine the frequency and the degree of each side effect that will appear to the patient at each course of chemotherapy .


Original Secondary Outcome: Same as current

Information By: Kansai Hepatobiliary Oncology Group

Dates:
Date Received: June 28, 2014
Date Started: June 2014
Date Completion: May 2019
Last Updated: August 31, 2016
Last Verified: August 2016