Not Signed In -
Ileostomy, Colostomy, and Ileoanal Reservoir Surgery |
|
|
Clinical Trial: A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared with Surgery Alone (NSAS-CC)
This study is no longer recruiting patients.
|
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 | Phase III |
MedlinePlus related topics: Colorectal Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)
Further Study Details:
Primary Outcomes: Relapse-free survival and overall survival
Secondary Outcomes: Adverse events
Expected Total Enrollment: 900
Secondary Outcomes: Adverse events
Expected Total Enrollment: 900
Study start: October 1996; Study completion: March 2007
Last follow-up: March 2006; Data entry closure: September 2006
Eligibility
Ages Eligible for Study: 20 Years - 75 Years, Genders Eligible for Study: Both
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
Location Information
Study chairs or principal investigators
Shigeaki Yoshida, MD, Principal Investigator, National Cancer Center Hospital East
More Information
Study ID Numbers: 01023002
Last Updated: September 12, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00152230
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 12, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00152230
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13
email this page
print this page
bookmark this page
feedback on this page
