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

This study has been completed.
Sponsor:
Information provided by:
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00152217
First received: September 8, 2005
Last updated: July 6, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Drug: TS-1 (S-1)
Procedure: Surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: every course for first three courses, then every other course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse-free survival, adverse events [ Time Frame: any time ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: September 2001
Study Completion Date: December 2010
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TS-1 (S-1)
 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
2
Surgery alone
 Procedure: Surgery
Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152217

Locations
Japan
National Cancer Center Hospital
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Mitsuru Sasako, MD Department of Upper Gastrointestinal Surgery, Hyogo College of Medicine
  More Information

Publications:

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00152217     History of Changes
Other Study ID Numbers: 91023038
Study First Received: September 8, 2005
Last Updated: July 6, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Taiho Pharmaceutical Co., Ltd.:
Stomach cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 21, 2013