Developing a trial design to establish BNCT as clinical application: insight for the national italian center for oncological hadrontherapy (CNAO)

Purpose: Boron Neutron Capture Therapy (BNCT) represents an advanced radiation therapy capable of selectively killing tumor cells. It operates on a dual therapy approach, utilizing boronated agents that preferentially deliver boron-10 to tumors, followed by neutron irradiation. This leads to the emission of two ionizing particles. These particles expend all their energy over a distance comparable to the diameter of a cell and can cause irreparable damage to DNA when passing through the nucleus. Methods: This paper outlines the approach taken by the Italian National Cancer Center for Oncological Hadrontherapy (CNAO) to achieve BNCT certification for clinical applications within the EU regulatory framework. Results: The existing literature reports excellent outcomes for many unresectable and recurrent tumors, especially in head and neck cancer (HNC). Conclusions: The paper seeks to clarify the rationale and methods for formulating a clinical trial design to meet these objectives.