A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (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.
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