- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00152243
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
July 6, 2011 updated by: Taiho Pharmaceutical Co., Ltd.
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)
This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone.
Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection.
To assess treatment response, 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 16 months after the start of treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
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
-
-
Tokyo
-
3-10-6, Ariake, Koto-ku, Tokyo, Japan
- Cancer Institute Hospital, Japanese Foundation For Cancer Research
-
-
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
20 years to 75 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 ≤ 1.5 times ULN
- Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN
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)
|
uracil-tegafur 360 mg per square meter per day orally 16 months
|
Other: 2
Surgery alone
|
Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival and relapse-free 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: Toshifusa Nakajima, MD, Cancer Institute Hospital
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.
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
June 1, 1997
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
August 1, 2007
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
Other Study ID Numbers
- 01023003
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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-
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-
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-
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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