Back to resultsA Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
UFT (uracil, tegafur)
Surgery alone
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Stomach Cancer
Eligibility 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 ≤ 1.5 times ULN Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN Exclusion Criteria: Prior anticancer treatment
Sites / Locations
- Cancer Institute Hospital, Japanese Foundation for Cancer Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
UFT (uracil, tegafur)
Surgery alone
Outcomes
Primary Outcome Measures
Overall survival and relapse-free survival
Secondary Outcome Measures
Adverse events
Full Information
NCT ID
NCT00152243
First Posted
September 8, 2005
Last Updated
July 6, 2011
Sponsor
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00152243
Brief Title
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
Official Title
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
June 1997 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Stomach Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
UFT (uracil, tegafur)
Arm Title
2
Arm Type
Other
Arm Description
Surgery alone
Intervention Type
Drug
Intervention Name(s)
UFT (uracil, tegafur)
Intervention Description
uracil-tegafur 360 mg per square meter per day orally 16 months
Intervention Type
Procedure
Intervention Name(s)
Surgery alone
Intervention Description
Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.
Primary Outcome Measure Information:
Title
Overall survival and relapse-free survival
Time Frame
every course for first three courses, then every other course
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
any time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 ≤ 1.5 times ULN
Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN
Exclusion Criteria:
Prior anticancer treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshifusa Nakajima, MD
Organizational Affiliation
Cancer Institute Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute Hospital, Japanese Foundation for Cancer Research
City
3-10-6, Ariake, Koto-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
17948223
Citation
Nakajima T, Kinoshita T, Nashimoto A, Sairenji M, Yamaguchi T, Sakamoto J, Fujiya T, Inada T, Sasako M, Ohashi Y; National Surgical Adjuvant Study of Gastric Cancer Group. Randomized controlled trial of adjuvant uracil-tegafur versus surgery alone for serosa-negative, locally advanced gastric cancer. Br J Surg. 2007 Dec;94(12):1468-76. doi: 10.1002/bjs.5996.
Results Reference
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A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
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