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

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.

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.

The existing literature reports excellent outcomes for many unresectable and recurrent tumors, especially in head and neck cancer (HNC).

The paper seeks to clarify the rationale and methods for formulating a clinical trial design to meet these objectives.