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

NCT00152217 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2011-07-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mitsuru Sasako, MD · Department of Upper Gastrointestinal Surgery, Hyogo College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2007-05-31
Completion
2010-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152217 on ClinicalTrials.gov