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

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

TS-1 (S-1)

Surgery

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Stomach cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cancer Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm Description

TS-1 (S-1)

Surgery alone

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Relapse-free survival, adverse events

Full Information

NCT ID

NCT00152217

First Posted

September 8, 2005

Last Updated

July 6, 2011

Sponsor

Taiho Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00152217

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

September 2001 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Taiho Pharmaceutical Co., Ltd.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Stomach cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

TS-1 (S-1)

Arm Title

Arm Type

Other

Arm Description

Surgery alone

Intervention Type

Drug

Intervention Name(s)

TS-1 (S-1)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

every course for first three courses, then every other course

Secondary Outcome Measure Information:

Title

Relapse-free survival, adverse events

Time Frame

any time

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitsuru Sasako, MD

Organizational Affiliation

Department of Upper Gastrointestinal Surgery, Hyogo College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center Hospital

City

5-1-1, Tsukiji, Chuo-ku

State/Province

Tokyo

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

17978289

Citation

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.

Results Reference

result

PubMed Identifier

29678146

Citation

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.

Results Reference

derived

Learn more about this trial

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

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