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NCT Number: NCT00152243

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

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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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Institute Hospital, Japanese Foundation for Cancer Research

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UFT (uracil, tegafur)

Drug

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

Surgery alone

Procedure

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

Primary outcomes

  1. Overall survival and relapse-free survival

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

Secondary outcomes

  1. Adverse events

    Time frame: any time

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)

Important dates

Study start
1997
Primary completion
2006
Study completion
2007
First posted
Sep 9, 2005
Registry last updated
Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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