Neoadjuvant radiotherapy {+/-} tegafur-uracil plus leucovorin in rectal adenocarcinoma: Final results of a French multicenter phase III study

4104 Background: Neoadjuvant chemoradiotherapy (CRT) with tegafur-uracil (UFT) plus leucovorin (LV) has shown promising results in patients with rectal adenocarcinoma (RAC). We therefore conducted a phase III trial to compare neoadjuvant CRT with UFT/LV versus radiotherapy (RT) alone. Methods: One hundred seventy seven pts with RAC stage T3 (T4 if anal extension) N<2, M0 were randomized to either RT alone (RT) (1.8 Gy/d, 45 G total) 5 days/w for 5 weeks or combined to CT (CRT) with daily UFT 300 mg/m2 plus leucovorin 75 mg for 5 weeks. TME surgery was performed 6–8 weeks after treatment. Adjuvant CT permitted at investigator discretion. Primary endpoint was pathological complete response rate (pCR), secondary endpoints included downstaging, QOL, sphincter preservation, recurrence rates, disease-free and overall survival. Results: Of 177 pts, 87 pts were allocated to RT and 90 to CRT. Compliance: RT dose intensity 98.8 % (n=86) in RT arm vs 95.6 % (n=86) in CRT arm with UFT mean dose 295.7 ± 19.8 mg/m2. 17...