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 Barba; Fabio Maria Vecchio; Ernesto Maranzano; Domenico Genovesi; Giovanni Battista Doglietto; Alessio Giuseppe Morganti; Giuseppe La Torre; Salvatore Pucciarelli; Antonino De Paoli

doi:10.1016/j.radonc.2018.11.023

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 journal › Article › peer-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 language	English
Pages (from-to)	110-118
Number of pages	9
Journal	Radiotherapy and Oncology
Volume	134
DOIs	https://doi.org/10.1016/j.radonc.2018.11.023
Publication status	Published - May 2019

Keywords

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

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10.1016/j.radonc.2018.11.023

https://pubmed.ncbi.nlm.nih.gov/31005204

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Valentini, V., Gambacorta, M. A., Cellini, F., Aristei, C., Coco, C., Barbaro, B., Alfieri, S., D'Ugo, D., Persiani, R., Deodato, F., Crucitti, A., Lupattelli, M., Mantello, G., Navarria, F., Belluco, C., Buonadonna, A., Boso, C., Lonardi, S., Caravatta, L., ... De Paoli, A. (2019). 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. Radiotherapy and Oncology, 134, 110-118. https://doi.org/10.1016/j.radonc.2018.11.023

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

In: Radiotherapy and Oncology, Vol. 134, 05.2019, p. 110-118.

Research output: Contribution to journal › Article › peer-review

Valentini, V , Gambacorta, MA , Cellini, F, Aristei, C, Coco, C, Barbaro, B, Alfieri, S , D'Ugo, D , Persiani, R, Deodato, F, Crucitti, A, Lupattelli, M, Mantello, G, Navarria, F , Belluco, C , Buonadonna, A, Boso, C, Lonardi, S, Caravatta, L, Barba, MC, Vecchio, FM, Maranzano, E, Genovesi, D, Doglietto, GB, Morganti, AG, La Torre, G, Pucciarelli, S & De Paoli, A 2019, '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', Radiotherapy and Oncology, vol. 134, pp. 110-118. https://doi.org/10.1016/j.radonc.2018.11.023

Valentini, Vincenzo ; Gambacorta, Maria Antonietta ; Cellini, Francesco ; Aristei, Cynthia ; Coco, Claudio ; Barbaro, Brunella ; Alfieri, Sergio ; D'Ugo, Domenico ; Persiani, Roberto ; Deodato, Francesco ; Crucitti, Antonio ; Lupattelli, Marco ; Mantello, Giovanna ; Navarria, Federico ; Belluco, Claudio ; Buonadonna, Angela ; Boso, Caterina ; Lonardi, Sara ; Caravatta, Luciana ; Barba, Maria Cristina ; Vecchio, Fabio Maria ; Maranzano, Ernesto ; Genovesi, Domenico ; Doglietto, Giovanni Battista ; Morganti, Alessio Giuseppe ; La Torre, Giuseppe ; Pucciarelli, Salvatore ; De Paoli, Antonino. / 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. In: Radiotherapy and Oncology. 2019 ; Vol. 134. pp. 110-118.

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title = "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",

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 ",

keywords = "*Boost, *Chemoradiation, *Oxaliplatin, *Pathologic complete response, *Preoperative radiochemotherapy, *Rectal cancer",

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

year = "2019",

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doi = "10.1016/j.radonc.2018.11.023",

language = "English",

volume = "134",

pages = "110--118",

journal = "Radiotherapy and Oncology",

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publisher = "Elsevier Ireland Ltd",

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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 -