Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1783651641312935936 |
---|---|
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. |
format | Online Article Text |
id | pubmed-7885611 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT paiellasalvatore aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT malleogiuseppe aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT simoninicola aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT micerarenato aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT guarigliastefania aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT cavedoncarlo aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT marchegianigiovanni aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT espositoalessandro aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT landoniluca aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT casettiluca aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT tuverimassimiliano aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT milellamichele aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT secchettinerica aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT manzinigessica aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT bovochiara aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT depastenamatteo aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT fontanamartina aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT salviaroberto aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT mazzarottorenzo aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT bassiclaudio aphaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT paiellasalvatore phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT malleogiuseppe phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT simoninicola phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT micerarenato phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT guarigliastefania phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT cavedoncarlo phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT marchegianigiovanni phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT espositoalessandro phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT landoniluca phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT casettiluca phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT tuverimassimiliano phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT milellamichele phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT secchettinerica phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT manzinigessica phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT bovochiara phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT depastenamatteo phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT fontanamartina phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT salviaroberto phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT mazzarottorenzo phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma AT bassiclaudio phaseiitrialproposaloftotalneoadjuvanttreatmentwithprimarychemotherapystereotacticbodyradiationtherapyandintraoperativeradiationtherapyinborderlineresectablepancreaticadenocarcinoma |