- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00152230
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
July 6, 2011 updated by: Taiho Pharmaceutical Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
900
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
- National Cancer Center Hospital East
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
UFT (uracil, tegafur)
|
to receive oral uracil-tegafur 400 mg square meter for one year
|
Other: 2
Surgery alone
|
Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse-free survival and overall survival
Time Frame: every course for first three courses, then every other course
|
every course for first three courses, then every other course
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: any time
|
any time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shigeaki Yoshida, MD, National Cancer Center Hospital East
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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 lymphadenectomy: a multicenter randomized controlled trial. Jpn J Clin Oncol. 2006 Apr;36(4):237-44. doi: 10.1093/jjco/hyl014. Epub 2006 May 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1996
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 9, 2005
Study Record Updates
Last Update Posted (Estimate)
July 7, 2011
Last Update Submitted That Met QC Criteria
July 6, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tegafur
Other Study ID Numbers
- 01023002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Translational Research Center for Medical Innovation...Tokyo Medical and Dental UniversityCompleted
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Translational Research Center for Medical Innovation...Tokyo Medical and Dental UniversityCompleted
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Egyptian Society of Liver CancerTerminated
-
Chang Gung Memorial HospitalUnknownSquamous Cell Carcinoma of Oral CavityTaiwan
-
Yokohama City UniversityUnknown
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Institut Cancerologie de l'OuestMerck Sharp & Dohme LLCTerminatedRectal Cancer | Stage II/III | T3 or T4 (Only Anal Extension) Rectal Cancer | N0-2 | M0France
-
Translational Research Center for Medical Innovation...Completed