GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer
NCT02182778 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246
Last updated 2019-02-21
Summary
To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.
Conditions
- Biliary Tract Cancer
Interventions
- 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.
Sponsors & Collaborators
-
Kansai Hepatobiliary Oncology Group
lead NETWORK
Principal Investigators
-
Masashi Kanai · Kyoto University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-09
- Primary Completion
- 2016-02-04
- Completion
- 2018-04-16
Countries
- Japan
Study Locations
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