Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer
NCT01171755 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2014-05-21
Summary
In current study, we evaluate the efficacy of gemcitabine and TS-1 combination chemotherapy in advanced BTC.
Conditions
- Biliary Tract Cancer
Interventions
- DRUG
-
Gemcitabine TS-1
Gemcitabine (1,000mg/m2) will be administered on days 1 and 8 at every 3 weeks TS-1 will be administered orally according to body surface area (BSA) as follows : BSA\<1.25 M2, 80 mg/day; 1.25 M2≤BSA\<1.5 M2, 100 mg/day; 1.5 M2≤BSA, 120 mg/day for 14 consecutive days followed by a 7-day rest.
Sponsors & Collaborators
-
Samsung Medical Center
lead OTHER
Principal Investigators
-
Yeong Lim Lim, Professor · Samsung Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2009-12-31
- Completion
- 2009-12-31
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