NCT02182778

GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Kansai Hepatobiliary Oncology Group · Network
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine/Cisplatin	Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
DRUG	Gemcitabine/Cisplatin /S-1	S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.

Timeline

• Start date: 2014-07-09
• Primary completion: 2016-02-04
• Completion: 2018-04-16
• First posted: 2014-07-08
• Last updated: 2019-02-21

Locations

1 site across 1 country: Japan