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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152217
• Other study ID #: 91023038
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: July 6, 2011
• Start date: September 2001
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2010
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

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

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	5-1-1, Tsukiji, Chuo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		every course for first three courses, then every other course	No
Secondary	Relapse-free survival, adverse events		any time	Yes