Gastric Cancer
Conditions
Keywords
Stomach cancer
Brief summary
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.
Interventions
DRUGTS-1 (S-1)
80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks
PROCEDURESurgery
Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | every course for first three courses, then every other course |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, adverse events | any time |
Countries
Japan
Outcome results
None listed