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BMC Cancer
Published in: BMC Cancer 1/2019

Open Access 01-12-2019 | Radiotherapy | Study protocol

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

Authors: 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

Published in: BMC Cancer | Issue 1/2019

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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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Metadata
Title
Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study
Authors
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
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2019
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-019-6108-0

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