Phase I/II trial of @entity416 , XXXX , and radiation for @entity5 .

@entity901 @entity1 @entity137 @entity416 @entity66 @entity5 @entity294 @entity1431 @entity1487
PURPOSE: The purpose of this study was to establish the feasibility and efficacy of preoperative radiotherapy (RT) with concurrent @entity416 and @entity901 (XELOX-RT) in @entity1 with @entity5 . @entity1 AND METHODS: Thirty-two @entity1 with locally advanced (T3/T4) or low-lying @entity5 received preoperative RT (total dose, 50.4 Gy). @entity416 was administered concurrently at 825 mg/m2 bid on days 1 to 14 and 22 to 35, with @entity901 starting at 50 mg/m2 on days 1, 8, 22, and 29 with planned escalation steps of 10 mg/m2. End points of the phase II study included downstaging, histopathologic tumor regression, resectability of @entity66 , and sphincter preservation in @entity1 with @entity5 . RESULTS: Dose-limiting grade 3 gastrointestinal @entity137 was observed in two of six @entity1 treated with 60 mg/m2 of @entity901 . Thus, 50 mg/m2 was the recommended dose for the phase II study. @entity137 observed at this dose level were generally mild, with only two cases of short-lived grade 3 @entity294 . Myelosuppression, mainly @entity1431 , was restricted to grade 2 in 19% of @entity1 . T-category downstaging was achieved in 17 (55%) of 31 operated @entity1 , and 68% of @entity1 had negative lymph nodes. Pathologic complete response was found in 19% of the resected specimens. Radical surgery with free margins could be performed in 79% of @entity1 with @entity66 , and 36% of @entity1 with @entity5 < or = 2 cm from the dentate line had sphincter-saving surgery. CONCLUSION: Preoperative XELOX-RT is a feasible and well tolerated treatment. This regimen is proposed for phase III evaluation comparing standard @entity1487 -based therapy with XELOX chemoradiotherapy.
