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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152243
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : July 7, 2011
Information provided by:
Taiho Pharmaceutical Co., Ltd.

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 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: UFT (uracil, tegafur) Procedure: Surgery alone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)
Study Start Date : June 1997
Actual Primary Completion Date : March 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: 1
UFT (uracil, tegafur)
Drug: UFT (uracil, tegafur)
uracil-tegafur 360 mg per square meter per day orally 16 months

Surgery alone
Procedure: Surgery alone
Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.

Primary Outcome Measures :
  1. Overall survival and relapse-free survival [ Time Frame: every course for first three courses, then every other course ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: any time ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00152243

Cancer Institute Hospital, Japanese Foundation for Cancer Research
3-10-6, Ariake, Koto-ku, Tokyo, Japan
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Principal Investigator: Toshifusa Nakajima, MD Cancer Institute Hospital

Publications of Results:
Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00152243     History of Changes
Other Study ID Numbers: 01023003
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011

Keywords provided by Taiho Pharmaceutical Co., Ltd.:
Stomach Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents