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A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma

BACKGROUND: The current management guidelines recommend that patients with borderline resectable pancreatic adenocarcinoma (BRPC) should initially receive neoadjuvant chemotherapy. The addition of advanced radiation therapy modalities, including stereotactic body radiation therapy (SBRT) and intraop...

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Autores principales: Paiella, Salvatore, Malleo, Giuseppe, Simoni, Nicola, Micera, Renato, Guariglia, Stefania, Cavedon, Carlo, Marchegiani, Giovanni, Esposito, Alessandro, Landoni, Luca, Casetti, Luca, Tuveri, Massimiliano, Milella, Michele, Secchettin, Erica, Manzini, Gessica, Bovo, Chiara, De Pastena, Matteo, Fontana, Martina, Salvia, Roberto, Mazzarotto, Renzo, Bassi, Claudio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885611/
https://www.ncbi.nlm.nih.gov/pubmed/33593311
http://dx.doi.org/10.1186/s12885-021-07877-7
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author Paiella, Salvatore
Malleo, Giuseppe
Simoni, Nicola
Micera, Renato
Guariglia, Stefania
Cavedon, Carlo
Marchegiani, Giovanni
Esposito, Alessandro
Landoni, Luca
Casetti, Luca
Tuveri, Massimiliano
Milella, Michele
Secchettin, Erica
Manzini, Gessica
Bovo, Chiara
De Pastena, Matteo
Fontana, Martina
Salvia, Roberto
Mazzarotto, Renzo
Bassi, Claudio
author_facet Paiella, Salvatore
Malleo, Giuseppe
Simoni, Nicola
Micera, Renato
Guariglia, Stefania
Cavedon, Carlo
Marchegiani, Giovanni
Esposito, Alessandro
Landoni, Luca
Casetti, Luca
Tuveri, Massimiliano
Milella, Michele
Secchettin, Erica
Manzini, Gessica
Bovo, Chiara
De Pastena, Matteo
Fontana, Martina
Salvia, Roberto
Mazzarotto, Renzo
Bassi, Claudio
author_sort Paiella, Salvatore
collection PubMed
description BACKGROUND: The current management guidelines recommend that patients with borderline resectable pancreatic adenocarcinoma (BRPC) should initially receive neoadjuvant chemotherapy. The addition of advanced radiation therapy modalities, including stereotactic body radiation therapy (SBRT) and intraoperative radiation therapy (IORT), could result in a more effective neoadjuvant strategy, with higher rates of margin-free resections and improved survival outcomes. METHODS/DESIGN: In this single-center, single-arm, intention-to-treat, phase II trial newly diagnosed BRPC will receive a “total neoadjuvant” therapy with FOLFIRINOX (5-fluorouracil, irinotecan and oxaliplatin) and hypofractionated SBRT (5 fractions, total dose of 30 Gy with simultaneous integrated boost of 50 Gy on tumor-vessel interface). Following surgical exploration or resection, IORT will be also delivered (10 Gy). The primary endpoint is 3-year survival. Secondary endpoints include completion of neoadjuvant treatment, resection rate, acute and late toxicities, and progression-free survival. In the subset of patients undergoing resection, per-protocol analysis of disease-free and disease-specific survival will be performed. The estimated sample size is 100 patients over a 36-month period. The trial is currently recruiting. TRIAL REGISTRATION: NCT04090463 at clinicaltrials.gov.
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spelling pubmed-78856112021-02-22 A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma Paiella, Salvatore Malleo, Giuseppe Simoni, Nicola Micera, Renato Guariglia, Stefania Cavedon, Carlo Marchegiani, Giovanni Esposito, Alessandro Landoni, Luca Casetti, Luca Tuveri, Massimiliano Milella, Michele Secchettin, Erica Manzini, Gessica Bovo, Chiara De Pastena, Matteo Fontana, Martina Salvia, Roberto Mazzarotto, Renzo Bassi, Claudio BMC Cancer Study Protocol BACKGROUND: The current management guidelines recommend that patients with borderline resectable pancreatic adenocarcinoma (BRPC) should initially receive neoadjuvant chemotherapy. The addition of advanced radiation therapy modalities, including stereotactic body radiation therapy (SBRT) and intraoperative radiation therapy (IORT), could result in a more effective neoadjuvant strategy, with higher rates of margin-free resections and improved survival outcomes. METHODS/DESIGN: In this single-center, single-arm, intention-to-treat, phase II trial newly diagnosed BRPC will receive a “total neoadjuvant” therapy with FOLFIRINOX (5-fluorouracil, irinotecan and oxaliplatin) and hypofractionated SBRT (5 fractions, total dose of 30 Gy with simultaneous integrated boost of 50 Gy on tumor-vessel interface). Following surgical exploration or resection, IORT will be also delivered (10 Gy). The primary endpoint is 3-year survival. Secondary endpoints include completion of neoadjuvant treatment, resection rate, acute and late toxicities, and progression-free survival. In the subset of patients undergoing resection, per-protocol analysis of disease-free and disease-specific survival will be performed. The estimated sample size is 100 patients over a 36-month period. The trial is currently recruiting. TRIAL REGISTRATION: NCT04090463 at clinicaltrials.gov. BioMed Central 2021-02-16 /pmc/articles/PMC7885611/ /pubmed/33593311 http://dx.doi.org/10.1186/s12885-021-07877-7 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Paiella, Salvatore
Malleo, Giuseppe
Simoni, Nicola
Micera, Renato
Guariglia, Stefania
Cavedon, Carlo
Marchegiani, Giovanni
Esposito, Alessandro
Landoni, Luca
Casetti, Luca
Tuveri, Massimiliano
Milella, Michele
Secchettin, Erica
Manzini, Gessica
Bovo, Chiara
De Pastena, Matteo
Fontana, Martina
Salvia, Roberto
Mazzarotto, Renzo
Bassi, Claudio
A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma
title A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma
title_full A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma
title_fullStr A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma
title_full_unstemmed A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma
title_short A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma
title_sort phase ii trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885611/
https://www.ncbi.nlm.nih.gov/pubmed/33593311
http://dx.doi.org/10.1186/s12885-021-07877-7
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