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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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