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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

TS-1 (S-1)

Group Type EXPERIMENTAL

TS-1 (S-1)

Intervention Type 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

2

Surgery alone

Group Type OTHER

Surgery

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type DRUG

Surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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