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

This study has been completed.
Information provided by:
Taiho Pharmaceutical Co., Ltd. Identifier:
First received: September 8, 2005
Last updated: July 6, 2011
Last verified: July 2011
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 Intervention Phase
Gastric Cancer Drug: UFT (uracil, tegafur) Procedure: Surgery alone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

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

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

Estimated Enrollment: 500
Study Start Date: June 1997
Study Completion Date: August 2007
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00152243     History of Changes
Other Study ID Numbers: 01023003
Study First Received: September 8, 2005
Last Updated: July 6, 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 processed this record on July 27, 2017