Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy

• Main Authors: Daniela Rega, Vincenza Granata, Antonella Petrillo, Ugo Pace, Cinzia Sassaroli, Massimiliano Di Marzo, Carmela Cervone, Roberta Fusco, Valeria D’Alessio, Guglielmo Nasti, Carmela Romano, Antonio Avallone, Biagio Pecori, Gerardo Botti, Fabiana Tatangelo, Piera Maiolino, Paolo Delrio
• Format: Article
• Language: English
• Published: MDPI AG 2021-06-01
• Series: Cancers
• Subjects: electrochemotherapy; locally advanced rectal cancer; endoluminal electrodes; conservative surgery; total mesorectal excision
• Online Access: https://www.mdpi.com/2072-6694/13/13/3199

Background: Currently, 45–55% of rectal cancer patients receive preoperative chemo- radio-therapy for Locally Advanced Rectal Cancer (LARC). The idea of our study is to use Electrochemotherapy (ECT) before surgery, in patients with major clinical response after neoadjuvant therapy, to allow for a more conservative surgical approach. Objective: To evaluate the increase of the complete response rate after neoadjuvant treatment in LARC and to spare organ function due to total mesorectal excision (TME). Patients and Methods: This is a Phase II randomized controlled trial enrolling 70 patients that will be developed in two stages. In the first step, 28 patients will be enrolled: 14 of these will receive ECT for four weeks after neo-adjuvant treatment and then local excision (treatment group) and 14 patients will receive neo-adjuvant treatment and then local excision (control group). If an increase of response rate is observed in the first stage, and/or feasibility/safety is demonstrated, the second stage of the trial will be performed, enrolling an additional 42 patients. The treatment response. in both the control arm and the treatment arm, will be assessed using the histopathological tumor regression grade on tissue specimens after local excision.