Gastric Cancer
Conditions
Keywords
Stomach Cancer
Brief summary
This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 16 months after the start of treatment.
Interventions
uracil-tegafur 360 mg per square meter per day orally 16 months
PROCEDURESurgery alone
Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 to 75 * Performance status 0 , 1, or 2 (ECOG) * Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3 * Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 times ULN * Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN
Exclusion criteria
* Prior anticancer treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival and relapse-free survival | every course for first three courses, then every other course |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | any time |
Countries
Japan
Outcome results
None listed