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

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

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
• Actual Primary Completion Date: May 2007
• Actual Study Completion Date: December 2010

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

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• 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

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 of Results:

Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252. Erratum In: N Engl J Med. 2008 May 1;358(18):1977.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ito S, Ohashi Y, Sasako M. Survival after recurrence in patients with gastric cancer who receive S-1 adjuvant chemotherapy: exploratory analysis of the ACTS-GC trial. BMC Cancer. 2018 Apr 20;18(1):449. doi: 10.1186/s12885-018-4341-6.

• Responsible Party: Taiho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00152217
• Other Study ID Numbers: 91023038
• First Posted: September 9, 2005
• 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