- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00152217
Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
July 6, 2011 updated by: Taiho Pharmaceutical Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
- National Cancer Center Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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
|
Other: 2
Surgery alone
|
Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: every course for first three courses, then every other course
|
every course for first three courses, then every other course
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse-free survival, adverse events
Time Frame: any time
|
any time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mitsuru Sasako, MD, Department of Upper Gastrointestinal Surgery, Hyogo College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 9, 2005
Study Record Updates
Last Update Posted (Estimate)
July 7, 2011
Last Update Submitted That Met QC Criteria
July 6, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91023038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage IB Gastric Cancer AJCC v8 | Pathologic Stage II Gastric Cancer AJCC v8 | Pathologic... and other conditionsUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7United States
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Clinical Trials on TS-1 (S-1)
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Chonnam National University HospitalCompleted
-
Kyungpook National University HospitalUnknownGastric CancerKorea, Republic of
-
Cancer Institute and Hospital, Chinese Academy...CompletedStomach Neoplasms | Chemotherapy | Neoadjuvant Therapy | ChemoradiotherapyChina
-
Min-Hee RyuCompletedGastric CancerKorea, Republic of
-
Peking UniversityTaiho Pharmaceutical Co., Ltd.Unknown
-
Soonchunhyang University HospitalUnknownGastric Cancer | Elderly | Oxaliplatin | S-1 | First-Line
-
Asan Medical CenterNational Cancer Center, Korea; Chonbuk National University Hospital; Samsung... and other collaboratorsCompletedAdvanced Gastric CancerKorea, Republic of
-
Japan Clinical Cancer Research OrganizationKorean Cancer Study GroupCompleted
-
Xijing HospitalUnknownGastrointestinal CancerChina
-
National University Hospital, SingaporeYonsei University; National Cancer Centre, SingaporeUnknownRecurrent Gastric CancerSingapore