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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014