Status:
COMPLETED
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
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 U...
Eligibility Criteria
Inclusion
- 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
- Prior anticancer treatment
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00152243
Start Date
June 1 1997
End Date
August 1 2007
Last Update
July 7 2011
Active Locations (1)
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1
Cancer Institute Hospital, Japanese Foundation for Cancer Research
3-10-6, Ariake, Koto-ku, Tokyo, Japan