This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with TS-1 within 45 days after curative resection (curability A or B). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

Condition	Intervention	Phase
Gastric Cancer	Drug: TS-1 (S-1)  Procedure: Surgery	Phase III

Further Study Details: 

Primary Outcomes: Overall survival
Secondary Outcomes: Relapse-free survival, adverse events
Expected Total Enrollment:  1000

Ages Eligible for Study:  20 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age 20 to 80
• Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
• Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 mg/dL
• Renal Creatinine ≤ULN

Exclusion Criteria:

• Prior anticancer treatment

Japan, Tokyo
      National Cancer Center Hospital, 5-1-1,Tsukiji,Chuo-ku,  Tokyo,  Japan

Study chairs or principal investigators

Mitsuru Sasako, MD,  Principal Investigator,  National Cancer Center Hospital   

Study ID Numbers:  91023038
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152217
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13