Status:
COMPLETED
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
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 t...
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 ≤ 1.2mg/dL
- Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL
Exclusion
- Prior anticancer treatment
Key Trial Info
Start Date :
October 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00152230
Start Date
October 1 1996
End Date
February 1 2008
Last Update
July 7 2011
Active Locations (1)
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1
National Cancer Center Hospital East
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan