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

Colorectal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152230
• Other study ID #: 01023002
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: July 6, 2011
• Start date: October 1996
• Est. completion date: February 2008

Study information

• Verified date: July 2011
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: February 2008
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital East	6-5-1, Kashiwanoha, Kashiwa, Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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 — View Citation

Hamaguchi T, Shirao K, Moriya Y, Yoshida S, Kodaira S, Ohashi Y; NSAS-CC Group. Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC). Cancer Chemother Pharmacol. 2011 Mar;67(3):587-96. doi: 10.1007/s00280-010-1358-1. Epub 2010 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival and overall survival		every course for first three courses, then every other course	No
Secondary	Adverse events		any time	Yes