Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
NCT00287768 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 628
Last updated 2011-06-28
Summary
The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.
Conditions
Interventions
- DRUG
-
docetaxel + S-1
Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
- DRUG
-
S-1
S-1 po days 1-28 every 6 weeks
Sponsors & Collaborators
-
Korean Cancer Study Group
collaborator OTHER -
Japan Clinical Cancer Research Organization
lead OTHER
Principal Investigators
-
Masashi Fujii, MD PhD · Surugadai Nihon University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
- Primary Completion
- 2008-09-30
- Completion
- 2010-10-31
Countries
- Japan
Study Locations
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