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

This study has been completed.
Sponsor:
Information provided by:
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00152230
First received: September 8, 2005
Last updated: July 6, 2011
Last verified: July 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 in Patients With Dukes C Colorectal Cancer (NSAS-CC)

Resource links provided by NLM:


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
Experimental: 1
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
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 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:
Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00152230     History of Changes
Other Study ID Numbers: 01023002
Study First Received: September 8, 2005
Last Updated: July 6, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014