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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
History of Changes

September 8, 2005
July 6, 2011
October 1996
March 2006   (final data collection date for primary outcome measure)
Relapse-free survival and overall survival [ Time Frame: every course for first three courses, then every other course ] [ Designated as safety issue: No ]
Relapse-free survival and overall survival
Complete list of historical versions of study NCT00152230 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: any time ] [ Designated as safety issue: Yes ]
Adverse events
Not Provided
Not Provided
 
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone in Patients With Dukes C Colorectal Cancer (NSAS-CC)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: UFT (uracil, tegafur)
    to receive oral uracil-tegafur 400 mg square meter for one year
  • Procedure: Surgery alone
    Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.
  • Experimental: 1
    UFT (uracil, tegafur)
    Intervention: Drug: UFT (uracil, tegafur)
  • 2
    Surgery alone
    Intervention: Procedure: Surgery alone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
February 2008
March 2006   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00152230
01023002
Not Provided
Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Shigeaki Yoshida, MD National Cancer Center Hospital East
Taiho Pharmaceutical Co., Ltd.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP