GEM vs GEM+TS-1 for Advanced Pancreatic Cancer
NCT00514163 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2011-06-28
Summary
The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer
Conditions
Interventions
- DRUG
-
gemcitabine + S-1
gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks
- DRUG
-
gemcitabine DIV on day one , 8th and 15th
Sponsors & Collaborators
-
Japan Clinical Cancer Research Organization
lead OTHER
Principal Investigators
-
Takaaki Ikari, MD. PhD · Cancer Institute Ariake Hospital
-
Masafumi Suyama, M.D. PhD · Juntenndo University Hospital
-
Naoto Egawa, M.D. PhD · Komagome Hospital
-
Yasuji Omuro, M.D. PhD · Komagome Hospital
-
Takao Itoi, M.D. PhD · Tokyo Medical college
-
Atsushi Sofuni, M.D. PhD · Tokyo medical college
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2010-08-31
- Completion
- 2010-12-31
Countries
- Japan
Study Locations
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