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 journalArticlepeer-review

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

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Fingerprint Dive into the research topics of 'Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: A prospective, phase II, multicentre, single-arm study'. Together they form a unique fingerprint.

Cite this