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

Purpose

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 III

MedlinePlus related topics:

Cancer Stomach Cancer

ChemIDplus related topics:

Tegafur Uracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: any time ] [ Designated as safety issue: Yes ]

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
1: Experimental UFT (uracil, tegafur)	Drug: UFT (uracil, tegafur) uracil-tegafur 360 mg per square meter per day orally 16 months
2 Surgery alone	Procedure: Surgery alone Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152243

Locations


Japan, Tokyo
	Cancer Institute Hospital, Japanese Foundation for Cancer Research
	3-10-6, Ariake, Koto-ku, Tokyo, Japan

Sponsors and Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators


Principal Investigator:	Toshifusa Nakajima, MD	Cancer Institute Hospital

More Information

Publications of Results:

Nakajima T, Kinoshita T, Nashimoto A, Sairenji M, Yamaguchi T, Sakamoto J, Fujiya T, Inada T, Sasako M, Ohashi Y; on behalf of the National Surgical Adjuvant Study of Gastric Cancer Group. Randomized controlled trial of adjuvant uracil-tegafur versus surgery alone for serosa-negative, locally advanced gastric cancer. Br J Surg. 2007 Dec;94(12):1468-76.

Responsible Party:	Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers:	01023003
First Received:	September 8, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00152243
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Taiho Pharmaceutical Co., Ltd.:

Stomach Cancer

Study placed in the following topic categories:

Stomach Diseases

Digestive System Diseases

Digestive System Neoplasms

Tegafur

Gastrointestinal Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Stomach cancer

Additional relevant MeSH terms:

Antimetabolites

Neoplasms

Antimetabolites, Antineoplastic

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Taiho Pharmaceutical Co., Ltd.
Information provided by:	Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00152243