Status:

COMPLETED

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

Lead Sponsor:

Taiho Pharmaceutical Co., Ltd.

Conditions:

Gastric Cancer

Eligibility:

All Genders

20-75 years

Phase:

PHASE3

Brief Summary

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 U...

Eligibility Criteria

Inclusion

  • 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

  • Prior anticancer treatment

Key Trial Info

Start Date :

June 1 1997

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2007

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT00152243

Start Date

June 1 1997

End Date

August 1 2007

Last Update

July 7 2011

Active Locations (1)

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1

Cancer Institute Hospital, Japanese Foundation for Cancer Research

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