A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-06-30

Study Completion Date

2007-08-31

Brief Summary

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This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 16 months after the start of treatment.

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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

NONE

Study Groups

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1

UFT (uracil, tegafur)

Group Type EXPERIMENTAL

UFT (uracil, tegafur)

Intervention Type DRUG

uracil-tegafur 360 mg per square meter per day orally 16 months

2

Surgery alone

Group Type OTHER

Surgery alone

Intervention Type PROCEDURE

Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.

Interventions

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UFT (uracil, tegafur)

uracil-tegafur 360 mg per square meter per day orally 16 months

Intervention Type DRUG

Surgery alone

Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 20 to 75
* Performance status 0 , 1, or 2 (ECOG)
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 times ULN
* Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN