Trial | NCT00152217  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    titanium ...

  • Study Participants

    1000
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.
Study Started
Sep 30
2001
Primary Completion
May 31
2007
Study Completion
Dec 31
2010
Last Update
Jul 07
2011
Estimate

Drug TS-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

Procedure Surgery

Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only

1 Experimental

TS-1 (S-1)

2 Other

Surgery alone

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
No Results Posted