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

Vincenzo Valentini, Maria Antonietta Gambacorta, Francesco Cellini, Cynthia Aristei, Claudio Coco, Brunella Barbaro, Sergio Alfieri, Domenico D'Ugo, Roberto Persiani, Francesco Deodato, Antonio Crucitti, Marco Lupattelli, Giovanna Mantello, Federico Navarria, Claudio Belluco, Angela Buonadonna, Caterina Boso, Sara Lonardi, Luciana Caravatta, Maria Cristina BarbaFabio Maria Vecchio, Ernesto Maranzano, Domenico Genovesi, Giovanni Battista Doglietto, Alessio Giuseppe Morganti, Giuseppe La Torre, Salvatore Pucciarelli, Antonino De Paoli

Research output: Contribution to journalArticlepeer-review

Abstract

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 
Original languageEnglish
Pages (from-to)110-118
Number of pages9
JournalRadiotherapy and Oncology
Volume134
DOIs
Publication statusPublished - May 2019

Keywords

  • *Boost
  • *Chemoradiation
  • *Oxaliplatin
  • *Pathologic complete response
  • *Preoperative radiochemotherapy
  • *Rectal cancer

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