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

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ClinicalTrials.gov Identifier: NCT00152217
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : July 7, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Gastric Cancer Drug: TS-1 (S-1) Procedure: Surgery Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
Study Start Date : September 2001
Primary Completion Date : May 2007
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: every course for first three courses, then every other course ]

Secondary Outcome Measures :
  1. Relapse-free survival, adverse events [ Time Frame: any time ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011

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