HiSCO 03 study

Interventions: Start protocol treatment within 8 weeks after surgery.
If it was not possible to start within 8 weeks after surgery, state the reason on the treatment progress record sheet.
Test treatment
UFT is administered orally three times a day (about every 8 hours) avoiding one hour before and after meal, dividing equivalent amount of 300 to 600 mg of tegafur (300 mg/m 2/day). LV (Uzel tablet) is 75 mg/day divided three times a day, and it is orally administered simultaneously with UFT. This is administered for 28 consecutive days, followed by 7 days off. As this is one course, we will implement 5 courses (25W).
Primary outcome(s): Feasibility
An aborted case because of the reason of 1) or 2) is regarded as an event. An aborted case because of the reason of 3) to 5) is regarded as a censored case and calculated the cumulative completion rate by the Kaplan-Meier method or the like. For the calculation of the confidence interval of the cumulative completion rate at 25 weeks after UFT / LV administration, Greenwood’s equation is used.
1) Canceling due to side effects.
2) Canceling due to patient refusal.
3) Canceling due to complications after curative treatment.
4) Canceling due to recurrence or death.
5) Canceling cases due to patient transfers.
Study Design: single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose