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

• Published in: BMC cancer 2019-09, Vol.19 (1), p.922-7, Article 922
• Main Authors: Vitolo, Viviana, Cobianchi, Lorenzo, Brugnatelli, Silvia, Barcellini, Amelia, Peloso, Andrea, Facoetti, Angelica, Vanoli, Alessandro, Delfanti, Sara, Preda, Lorenzo, Molinelli, Silvia, Klersy, Catherine, Fossati, Piero, Orecchia, Roberto, Valvo, Francesca
• Format: Article
• Language: English
• Subjects: Adenocarcinoma; Adenocarcinoma - pathology; Adenocarcinoma - therapy; Adjuvant chemotherapy; Analysis; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer therapies; Cancer treatment; Carbon; Carbon ion radiation therapy; Care and treatment; Chemotherapy; Clinical Protocols; Clinical trials; Combined Modality Therapy; Female; Heavy Ion Radiotherapy - adverse effects; Heavy Ion Radiotherapy - methods; Humans; Male; Medical research; Mortality; Neoadjuvant therapy; Neoplasm Staging; Pancreatic adenocarcinoma; Pancreatic cancer; Pancreatic Neoplasms - pathology; Pancreatic Neoplasms - therapy; Patient outcomes; Preoperative Care; Radiation (Physics); Radiation therapy; Radiotherapy; Retirement benefits; Studies; Study Protocol; Surgery; Survival; Tumors
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-019-6108-0

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. 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. 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. ClinicalTrials.gov Identifier: NCT03822936 registered on January 2019.