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

NCT00152217 | Completed Phase 3

• 1 other identifier: 91023038
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Stomach cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  every course for first three courses, then every other course

Secondary Outcomes (1)

• Relapse-free survival, adverse events

  any time

Study Arms (2)

1

EXPERIMENTAL

TS-1 (S-1)

Drug: TS-1 (S-1)

2

OTHER

Surgery alone

Procedure: Surgery

Interventions

TS-1 (S-1) DRUG

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

1

Surgery PROCEDURE

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

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior anticancer treatment

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

National Cancer Center Hospital

5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan

Location

Related Publications (2)

• 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.

  PMID: 17978289 RESULT

• 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.

  PMID: 29678146 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

titanium silicide; S 1 (combination); Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Mitsuru Sasako, MD

  Department of Upper Gastrointestinal Surgery, Hyogo College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: September 1, 2001
• Primary Completion: May 1, 2007
• Study Completion: December 1, 2010
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

JP (1)