Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients
NCT00687843 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480
Last updated 2012-03-22
Summary
Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.
Conditions
Interventions
- DRUG
-
Tegafur-gimeracil-oteracil potassium (TS-1)
80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8
- DRUG
-
Krestin (PSK)
3 g, PO from day 1 to day 336
Sponsors & Collaborators
-
Tokyo Metropolitan Oncology Group
lead OTHER
Principal Investigators
-
Masatsugu Kitamura, MD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2016-03-31
- Completion
- 2016-03-31
Countries
- Japan
Study Locations
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