Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: A prospective, phase II, multicentre, single-arm study

Viviana Vitolo, Lorenzo Cobianchi, Silvia Brugnatelli, Amelia Barcellini, Andrea Peloso, Angelica Facoetti, Alessandro Vanoli, Sara Delfanti, Lorenzo Preda, Silvia Molinelli, Catherine Klersy, Piero Fossati, Roberto Orecchia, Francesca Valvo

Research output: Contribution to journalArticle

Abstract

Background: Pancreatic adenocarcinoma is a high-mortality neoplasm with a documented 5-years-overall survival around 5%. In the last decades, a real breakthrough in the treatment of the disease has not been achieved. Here we propose a prospective, phase II, multicentre, single-arm study aiming to assess the efficacy and the feasibility of a therapeutic protocol combining chemotherapy, carbon ion therapy and surgery for resectable and borderline resectable pancreatic adenocarcinoma. Method: The purpose of this trial (PIOPPO Protocol) is to assess the efficacy and the feasibility of 3 cycles of FOLFIRINOX neoadjuvant chemotherapy followed by a short-course of carbon ion radiotherapy (CIRT) for resectable or borderline resectable pancreatic adenocarcinoma patients. Primary outcome of this study is the assessment of local progression free survival (L-PFS). The calculation of sample size is based on the analysis of the primary endpoint "progression free survival" according to Fleming's Procedure. Discussion: Very preliminary results provide initial evidence of the feasibility of the combined chemotherapy and CIRT in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer. Completion of the accrual and long term results are awaited to see if this combination of treatment is advisable and will provide the expected benefits. Trial registration: ClinicalTrials.gov Identifier: NCT03822936 registered on January 2019.

Original languageEnglish
Article number922
JournalBMC Cancer
Volume19
Issue number1
DOIs
Publication statusPublished - Sep 14 2019

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Heavy Ion Radiotherapy
Adenocarcinoma
Drug Therapy
Disease-Free Survival
Clinical Protocols
Pancreatic Neoplasms
Sample Size
Therapeutics
Outcome Assessment (Health Care)
Survival
Mortality
Neoplasms

Keywords

  • Carbon ion radiation therapy
  • Chemotherapy
  • Pancreatic adenocarcinoma
  • Surgery

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Cite this

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title = "Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: A prospective, phase II, multicentre, single-arm study",
abstract = "Background: Pancreatic adenocarcinoma is a high-mortality neoplasm with a documented 5-years-overall survival around 5{\%}. In the last decades, a real breakthrough in the treatment of the disease has not been achieved. Here we propose a prospective, phase II, multicentre, single-arm study aiming to assess the efficacy and the feasibility of a therapeutic protocol combining chemotherapy, carbon ion therapy and surgery for resectable and borderline resectable pancreatic adenocarcinoma. Method: The purpose of this trial (PIOPPO Protocol) is to assess the efficacy and the feasibility of 3 cycles of FOLFIRINOX neoadjuvant chemotherapy followed by a short-course of carbon ion radiotherapy (CIRT) for resectable or borderline resectable pancreatic adenocarcinoma patients. Primary outcome of this study is the assessment of local progression free survival (L-PFS). The calculation of sample size is based on the analysis of the primary endpoint {"}progression free survival{"} according to Fleming's Procedure. Discussion: Very preliminary results provide initial evidence of the feasibility of the combined chemotherapy and CIRT in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer. Completion of the accrual and long term results are awaited to see if this combination of treatment is advisable and will provide the expected benefits. Trial registration: ClinicalTrials.gov Identifier: NCT03822936 registered on January 2019.",
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author = "Viviana Vitolo and Lorenzo Cobianchi and Silvia Brugnatelli and Amelia Barcellini and Andrea Peloso and Angelica Facoetti and Alessandro Vanoli and Sara Delfanti and Lorenzo Preda and Silvia Molinelli and Catherine Klersy and Piero Fossati and Roberto Orecchia and Francesca Valvo",
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T1 - Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma

T2 - A prospective, phase II, multicentre, single-arm study

AU - Vitolo, Viviana

AU - Cobianchi, Lorenzo

AU - Brugnatelli, Silvia

AU - Barcellini, Amelia

AU - Peloso, Andrea

AU - Facoetti, Angelica

AU - Vanoli, Alessandro

AU - Delfanti, Sara

AU - Preda, Lorenzo

AU - Molinelli, Silvia

AU - Klersy, Catherine

AU - Fossati, Piero

AU - Orecchia, Roberto

AU - Valvo, Francesca

PY - 2019/9/14

Y1 - 2019/9/14

N2 - Background: Pancreatic adenocarcinoma is a high-mortality neoplasm with a documented 5-years-overall survival around 5%. In the last decades, a real breakthrough in the treatment of the disease has not been achieved. Here we propose a prospective, phase II, multicentre, single-arm study aiming to assess the efficacy and the feasibility of a therapeutic protocol combining chemotherapy, carbon ion therapy and surgery for resectable and borderline resectable pancreatic adenocarcinoma. Method: The purpose of this trial (PIOPPO Protocol) is to assess the efficacy and the feasibility of 3 cycles of FOLFIRINOX neoadjuvant chemotherapy followed by a short-course of carbon ion radiotherapy (CIRT) for resectable or borderline resectable pancreatic adenocarcinoma patients. Primary outcome of this study is the assessment of local progression free survival (L-PFS). The calculation of sample size is based on the analysis of the primary endpoint "progression free survival" according to Fleming's Procedure. Discussion: Very preliminary results provide initial evidence of the feasibility of the combined chemotherapy and CIRT in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer. Completion of the accrual and long term results are awaited to see if this combination of treatment is advisable and will provide the expected benefits. Trial registration: ClinicalTrials.gov Identifier: NCT03822936 registered on January 2019.

AB - Background: Pancreatic adenocarcinoma is a high-mortality neoplasm with a documented 5-years-overall survival around 5%. In the last decades, a real breakthrough in the treatment of the disease has not been achieved. Here we propose a prospective, phase II, multicentre, single-arm study aiming to assess the efficacy and the feasibility of a therapeutic protocol combining chemotherapy, carbon ion therapy and surgery for resectable and borderline resectable pancreatic adenocarcinoma. Method: The purpose of this trial (PIOPPO Protocol) is to assess the efficacy and the feasibility of 3 cycles of FOLFIRINOX neoadjuvant chemotherapy followed by a short-course of carbon ion radiotherapy (CIRT) for resectable or borderline resectable pancreatic adenocarcinoma patients. Primary outcome of this study is the assessment of local progression free survival (L-PFS). The calculation of sample size is based on the analysis of the primary endpoint "progression free survival" according to Fleming's Procedure. Discussion: Very preliminary results provide initial evidence of the feasibility of the combined chemotherapy and CIRT in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer. Completion of the accrual and long term results are awaited to see if this combination of treatment is advisable and will provide the expected benefits. Trial registration: ClinicalTrials.gov Identifier: NCT03822936 registered on January 2019.

KW - Carbon ion radiation therapy

KW - Chemotherapy

KW - Pancreatic adenocarcinoma

KW - Surgery

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