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

Purpose

This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, 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 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.

Condition	Intervention	Phase
Colorectal Cancer	Drug: UFT (uracil, tegafur) Procedure: Surgery alone	Phase III

MedlinePlus related topics:

Cancer Colorectal 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 in Patients With Dukes C Colorectal Cancer (NSAS-CC)

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

Primary Outcome Measures:

Relapse-free survival and overall 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:	900
Study Start Date:	October 1996
Study Completion Date:	February 2008
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) to receive oral uracil-tegafur 400 mg square meter for one year
2 Surgery alone	Procedure: Surgery alone Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal 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 ≤ 1.2mg/dL
Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL

Exclusion Criteria:

Prior anticancer treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152230

Locations


Japan
	National Cancer Center Hospital East
	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan

Sponsors and Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators


Principal Investigator:	Shigeaki Yoshida, MD	National Cancer Center Hospital East

More Information

Publications of Results:

Akasu T, Moriya Y, Ohashi Y, Yoshida S, Shirao K, Kodaira S; National Surgical Adjuvant Study of Colorectal Cancer. Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: a multicenter randomized controlled trial. Jpn J Clin Oncol. 2006 Apr;36(4):237-44. Epub 2006 May 4.

Responsible Party:	Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers:	01023002
First Received:	September 8, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00152230
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Taiho Pharmaceutical Co., Ltd.:

Colorectal Cancer

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Tegafur

Gastrointestinal Diseases

Colonic Diseases

Gastrointestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Colorectal Neoplasms

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:	NCT00152230