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.

Tracking Information

• First Submitted Date: September 8, 2005
• First Posted Date: September 9, 2005
• Last Update Posted Date: July 7, 2011
• Study Start Date: September 2001
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 1, 2008): Overall survival [ Time Frame: every course for first three courses, then every other course ]
• Original Primary Outcome Measures (submitted: September 8, 2005): Overall survival
• Current Secondary Outcome Measures (submitted: July 1, 2008): Relapse-free survival, adverse events [ Time Frame: any time ]
• Original Secondary Outcome Measures (submitted: September 8, 2005): Relapse-free survival and safety
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
• Official Title: Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

• 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

Study Arms

• Experimental: 1
  TS-1 (S-1)
  Intervention: Drug: TS-1 (S-1)
• 2
  Surgery alone
  Intervention: Procedure: Surgery

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: September 8, 2005): 1000
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00152217
• Other Study ID Numbers: 91023038
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Taiho Pharmaceutical Co., Ltd.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Taiho Pharmaceutical Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mitsuru Sasako, MD; Department of Upper Gastrointestinal Surgery, Hyogo College of Medicine

• PRS Account: Taiho Pharmaceutical Co., Ltd.
• Verification Date: July 2011