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

BMC Cancer

Erica Secchettin¹  Roberto Salvia¹  Giuseppe Malleo¹  Matteo De Pastena¹  Giovanni Marchegiani¹  Salvatore Paiella¹  Alessandro Esposito¹  Gessica Manzini¹  Luca Casetti¹  Massimiliano Tuveri¹  Martina Fontana¹  Claudio Bassi¹  Luca Landoni¹  Michele Milella²  Stefania Guariglia³  Carlo Cavedon³  Renato Micera⁴  Renzo Mazzarotto⁴  Nicola Simoni⁴  Chiara Bovo⁵ 

[1] Unit of General and Pancreatic Surgery, University of Verona Hospital Trust;Unit of Medical Oncology, University of Verona Hospital Trust;Unit of Medical Physics, University of Verona Hospital Trust;Unit of Radiation Oncology, University of Verona Hospital Trust;University of Verona Hospital Trust Management Unit;

关键词: Intraoperative radiotherapy (IORT);    Pancreatic cancer;    Neoadjuvant therapy;    Locally advanced pancreatic cancer;    Stereotactic body radiation therapy (SBRT);   

DOI  :  10.1186/s12885-021-07877-7

来源: DOAJ

【 摘 要 】

Abstract 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.

【 授权许可】

Unknown