TY - JOUR
T1 - The INTERACT Trial: Long-term results of a randomised trial on preoperative capecitabine-based radiochemotherapy intensified by concomitant boost or oxaliplatin, for cT2 (distal)-cT3 rectal cancer
AU - Valentini, Vincenzo
AU - Gambacorta, Maria Antonietta
AU - Cellini, Francesco
AU - Aristei, Cynthia
AU - Coco, Claudio
AU - Barbaro, Brunella
AU - Alfieri, Sergio
AU - D'Ugo, Domenico
AU - Persiani, Roberto
AU - Deodato, Francesco
AU - Crucitti, Antonio
AU - Lupattelli, Marco
AU - Mantello, Giovanna
AU - Navarria, Federico
AU - Belluco, Claudio
AU - Buonadonna, Angela
AU - Boso, Caterina
AU - Lonardi, Sara
AU - Caravatta, Luciana
AU - Barba, Maria Cristina
AU - Vecchio, Fabio Maria
AU - Maranzano, Ernesto
AU - Genovesi, Domenico
AU - Doglietto, Giovanni Battista
AU - Morganti, Alessio Giuseppe
AU - La Torre, Giuseppe
AU - Pucciarelli, Salvatore
AU - De Paoli, Antonino
PY - 2019/5
Y1 - 2019/5
N2 - BACKGROUND AND PURPOSE: Capecitabine-based radiochemotherapy (cbRCT) is standard for preoperative long-course radiochemotherapy of locally advanced rectal cancer. This prospective, parallel-group, randomised controlled trial investigated two intensification regimens. cT4 lesions were excluded. PRIMARY OBJECTIVE: pathological outcome (TRG 1-2) among arms. MATERIALS AND METHODS: Low-located cT2N0-2M0, cT3N0-2M0 (up to 12 cm from anal verge) presentations were treated with cbRCT randomly intensified by either radiotherapy boost (Xelac arm) or multidrug concomitant chemotherapy (Xelox arm). Xelac: concomitant boost to bulky site (45 Gy/1.8 Gy/die, 5 sessions/week to the pelvis, +10 Gy at 1 Gy twice/week to the bulky) plus concurrent capecitabine (1650 mg/mq/die). Xelox: 45 Gy to the pelvis + 5.4 Gy/1.8 Gy/die, 5 sessions/week to the bulky site + concurrent capecitabine (1300 mg/mq/die) and oxaliplatin (130 mg/mq on days 1,19,38). Surgery was planned 7-9 weeks after radiochemotherapy. RESULTS: From June 2005 to September 2013, 534 patients were analysed: 280 in Xelac, 254 in Xelox arm. Xelox arm presented higher G ≥ 3 haematologic (p = 0.01) and neurologic toxicity (p
AB - BACKGROUND AND PURPOSE: Capecitabine-based radiochemotherapy (cbRCT) is standard for preoperative long-course radiochemotherapy of locally advanced rectal cancer. This prospective, parallel-group, randomised controlled trial investigated two intensification regimens. cT4 lesions were excluded. PRIMARY OBJECTIVE: pathological outcome (TRG 1-2) among arms. MATERIALS AND METHODS: Low-located cT2N0-2M0, cT3N0-2M0 (up to 12 cm from anal verge) presentations were treated with cbRCT randomly intensified by either radiotherapy boost (Xelac arm) or multidrug concomitant chemotherapy (Xelox arm). Xelac: concomitant boost to bulky site (45 Gy/1.8 Gy/die, 5 sessions/week to the pelvis, +10 Gy at 1 Gy twice/week to the bulky) plus concurrent capecitabine (1650 mg/mq/die). Xelox: 45 Gy to the pelvis + 5.4 Gy/1.8 Gy/die, 5 sessions/week to the bulky site + concurrent capecitabine (1300 mg/mq/die) and oxaliplatin (130 mg/mq on days 1,19,38). Surgery was planned 7-9 weeks after radiochemotherapy. RESULTS: From June 2005 to September 2013, 534 patients were analysed: 280 in Xelac, 254 in Xelox arm. Xelox arm presented higher G ≥ 3 haematologic (p = 0.01) and neurologic toxicity (p
KW - Boost
KW - Chemoradiation
KW - Oxaliplatin
KW - Pathologic complete response
KW - Preoperative radiochemotherapy
KW - Rectal cancer
U2 - 10.1016/j.radonc.2018.11.023
DO - 10.1016/j.radonc.2018.11.023
M3 - Article
VL - 134
SP - 110
EP - 118
JO - Radiotherapy and Oncology
JF - Radiotherapy and Oncology
SN - 0167-8140
ER -