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Randomized, Multicenter, Phase IIB Study of Preoperative Chemoradiotherapy in T3 Mid-Distal Rectal Cancer: Raltitrexed + Oxaliplatin + Radiotherapy Versus Cisplatin + 5-Fluorouracil + Radiotherapy by Vincenzo Valentini; Claudio Coco; Bruce D. Minsky; Maria Antonietta Gambacorta; Maurizio Cosimelli; Rita Bellavita; Alessio G. Morganti; Giuseppe La Torre; Lucio Trodella; Domenico Genovesi; Maurizio Portaluri; Riccardo Maurizi-Enrici; Fernando Barbera; Ernesto Maranzano; Marco Lupattelli is a Medicine article available to read on EtoBox.

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Purpose: To prospectively compare the rates of pathologic response, acute toxicity, and sphincter preservation with two different schedules of preoperative chemoradiotherapy in patients with cT3 mid-distal rectal cancer. Methods and Materials: Patients with cT3 and/or N+ resectable rectal carcinoma were randomized to receive one of the two following chemoradiotherapy regimens: cisplatin, 5-fluorouracil, and radiotherapy (PLAFUR) or raltitrexed, oxaliplatin, and radiotherapy (TOMOX-RT). For PLAFUR, cisplatin (60 mg/m 2 ) was given on Days 1 and 29, with a prolonged infusion of 5-fluorouracil (1,000 mg/m 2 ) on Days 1-4 and 29-32, plus concurrent radiotherapy (50.4 Gy in 1.8-Gy fractions daily). For TOMOX-RT, raltitrexed (3 mg/m 2 ) and oxaliplatin (130 mg/m 2 ) was given on Days 1, 19, and 38 with the same radiotherapy regimen as used for PLAFUR. Surgery was performed 6-8 weeks after completion of chemoradiotherapy. All pathologic specimens were reviewed by a designated expert pathologist. The primary endpoint of this study was pathologic tumor downstaging (defined as tumor regression grade 1-2). Secondary endpoints included the incidence of ypT0, clinical tumor downstaging, sphinct

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Author

Vincenzo Valentini; Claudio Coco; Bruce D. Minsky; Maria Antonietta Gambacorta; Maurizio Cosimelli; Rita Bellavita; Alessio G. Morganti; Giuseppe La Torre; Lucio Trodella; Domenico Genovesi; Maurizio Portaluri; Riccardo Maurizi-Enrici; Fernando Barbera; Ernesto Maranzano; Marco Lupattelli

Publisher

Elsevier Science; Elsevier ; Elsevier BV (ISSN 0360-3016)

Published

2008

Language

EN

Field

Medicine (Health Sciences)