Protracted infusions of 5-fluorouracil (5-FU) combined with pelvic radiothe
rapy have been associated with improved survival and decreased local and di
stant metastases in the adjuvant therapy of rectal cancer, However, this me
thod of 5-FU infusion requires the inconvenience and expense of central ven
ous line placement and care, infusion pumps, and treatment of catheter-rela
ted complications. We previously demonstrated that a completely oral therap
y with UFT (uracil plus tegafur in a 4:1 molar ratio) plus oral calcium fol
inate (Orzel) can achieve pharmacokinetic parameters similar to those assoc
iated with protracted 5-FU infusions. This trial examines the feasibility o
f using UFT plus oral calcium folinate both during preoperative pelvic radi
ation and postoperatively, and shows that patients can be treated safely an
d effectively with a completely oral chemotherapy program combining UFT plu
s oral calcium folinate with pelvic radiation therapy.