NCT00152230

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1996-10-01
• Primary completion: 2006-03-01
• Completion: 2008-02-01
• First posted: 2005-09-09
• Last updated: 2011-07-07

Locations

1 site across 1 country: Japan