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

BackgroundThe 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/designIn 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 30Gy with simultaneous integrated boost of 50Gy on tumor-vessel interface). Following surgical exploration or resection, IORT will be also delivered (10Gy). 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 registrationNCT04090463 at clinicaltrials.gov.

Automated summary

The study aims to investigate the efficacy of total neoadjuvant therapy with FOLFIRINOX and hypofractionated SBRT in patients with BRPC, followed by IORT, with the primary endpoint being 3-year survival. The trial plans to recruit 100 patients over 36 months and assess secondary endpoints such as completion of treatment, resection rate, toxicities, and progression-free survival.