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

NCT00152230 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2011-07-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shigeaki Yoshida, MD · National Cancer Center Hospital East

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-10-31
Primary Completion
2006-03-31
Completion
2008-02-29

Countries

  • Japan

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152230 on ClinicalTrials.gov