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Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy
SIMPLE SUMMARY: This is a Phase II randomized controlled trial conducted with the aim of investigating whether the use of Electrochemotherapy after neoadjuvant therapy (ECT) and before surgery in patients with major clinical response allows for a more conservative surgical approach in patients with...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267997/ https://www.ncbi.nlm.nih.gov/pubmed/34206858 http://dx.doi.org/10.3390/cancers13133199 |
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author | Rega, Daniela Granata, Vincenza Petrillo, Antonella Pace, Ugo Sassaroli, Cinzia Di Marzo, Massimiliano Cervone, Carmela Fusco, Roberta D’Alessio, Valeria Nasti, Guglielmo Romano, Carmela Avallone, Antonio Pecori, Biagio Botti, Gerardo Tatangelo, Fabiana Maiolino, Piera Delrio, Paolo |
author_facet | Rega, Daniela Granata, Vincenza Petrillo, Antonella Pace, Ugo Sassaroli, Cinzia Di Marzo, Massimiliano Cervone, Carmela Fusco, Roberta D’Alessio, Valeria Nasti, Guglielmo Romano, Carmela Avallone, Antonio Pecori, Biagio Botti, Gerardo Tatangelo, Fabiana Maiolino, Piera Delrio, Paolo |
author_sort | Rega, Daniela |
collection | PubMed |
description | SIMPLE SUMMARY: This is a Phase II randomized controlled trial conducted with the aim of investigating whether the use of Electrochemotherapy after neoadjuvant therapy (ECT) and before surgery in patients with major clinical response allows for a more conservative surgical approach in patients with Locally Advanced Rectal Cancer (LARC) in comparison with the control group that will not receive ECT. The treatment response, in both the control arm and in the treatment arm, will be assessed using the histopathological tumor regression grade on tissue specimens after local excision. ABSTRACT: 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. |
format | Online Article Text |
id | pubmed-8267997 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-82679972021-07-10 Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy Rega, Daniela Granata, Vincenza Petrillo, Antonella Pace, Ugo Sassaroli, Cinzia Di Marzo, Massimiliano Cervone, Carmela Fusco, Roberta D’Alessio, Valeria Nasti, Guglielmo Romano, Carmela Avallone, Antonio Pecori, Biagio Botti, Gerardo Tatangelo, Fabiana Maiolino, Piera Delrio, Paolo Cancers (Basel) Protocol SIMPLE SUMMARY: This is a Phase II randomized controlled trial conducted with the aim of investigating whether the use of Electrochemotherapy after neoadjuvant therapy (ECT) and before surgery in patients with major clinical response allows for a more conservative surgical approach in patients with Locally Advanced Rectal Cancer (LARC) in comparison with the control group that will not receive ECT. The treatment response, in both the control arm and in the treatment arm, will be assessed using the histopathological tumor regression grade on tissue specimens after local excision. ABSTRACT: 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. MDPI 2021-06-26 /pmc/articles/PMC8267997/ /pubmed/34206858 http://dx.doi.org/10.3390/cancers13133199 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Protocol Rega, Daniela Granata, Vincenza Petrillo, Antonella Pace, Ugo Sassaroli, Cinzia Di Marzo, Massimiliano Cervone, Carmela Fusco, Roberta D’Alessio, Valeria Nasti, Guglielmo Romano, Carmela Avallone, Antonio Pecori, Biagio Botti, Gerardo Tatangelo, Fabiana Maiolino, Piera Delrio, Paolo Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy |
title | Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy |
title_full | Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy |
title_fullStr | Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy |
title_full_unstemmed | Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy |
title_short | Organ Sparing for Locally Advanced Rectal Cancer after Neoadjuvant Treatment Followed by Electrochemotherapy |
title_sort | organ sparing for locally advanced rectal cancer after neoadjuvant treatment followed by electrochemotherapy |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267997/ https://www.ncbi.nlm.nih.gov/pubmed/34206858 http://dx.doi.org/10.3390/cancers13133199 |
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