Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)

Taiho Pharma

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Procedure: Surgery; Drug: TS-1 (S-1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152217

91023038

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups

1

Experimental group

Description:

TS-1 (S-1)

Treatment:

Drug: TS-1 (S-1)

2

Other group

Description:

Surgery alone

Treatment:

Procedure: Surgery