Journal Article

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

Mazzarotto, Renzo, De Pastena, Matteo, Marchegiani, Giovanni, Paiella, Salvatore, Malleo, Giuseppe, Milella, Michele, Fontana, Martina, Guariglia, Stefania, Esposito, Alessandro, Secchettin, Erica, Micera, Renato, Bovo, Chiara, Bassi, Claudio, Casetti, Luca, Salvia, Roberto, Landoni, Luca, Manzini, Gessica, Cavedon, Carlo, Tuveri, Massimiliano, Simoni, Nicola

2021

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: 5-Fluorouracil / Abdomen / Adenocarcinoma / Biomedical and Life Sciences / Biomedicine / cancer imaging / Cancer Research / Cancer therapies / Cardiovascular disease / Care and treatment / Chemotherapy / Clinical trials / Development and progression / Dosimetry / Endoscopy / Health Promotion and Disease Prevention / Hospitals / interventional therapeutics / Intraoperative radiotherapy (IORT) / Irinotecan / Locally advanced pancreatic cancer / Medical prognosis / Medicine/Public Health / Methods / Neoadjuvant therapy / Oncology / Oxaliplatin / Pancreas / Pancreatic cancer / Patient outcomes / Radiation therapy / Radiotherapy / Stereotactic body radiation therapy (SBRT) / Study Protocol / Surgery / Surgical Oncology / Survival / Ultrasonic imaging