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

Taiho Pharmaceutical Co., Ltd.500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Gastric Cancer

Interventions

UFT (uracil, tegafur)DRUG

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

Surgery alonePROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Prior anticancer treatment

Locations (1)

Cancer Institute Hospital, Japanese Foundation for Cancer Research

3-10-6, Ariake, Koto-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Overall survival and relapse-free survival

Time frame: every course for first three courses, then every other course

Secondary Outcomes

Adverse events

Time frame: any time

Data from ClinicalTrials.gov

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