Phase I Study of Accelerator-Based Boron Neutron Capture Therapy BNCT for Inoperable, Locally Recurrent Head and Neck Cancer Previously Treated with Radiation

What this Trial Is About

Researchers are studying a new type of radiation treatment called accelerator-based boron neutron capture therapy BNCT for patients with head and neck carcinoma that has returned locally after conventional radiation therapy. This phase I study, sponsored by Neutron Therapeutics, aims primarily to evaluate the safety of delivering BNCT using the nuBeam Suite. The study also examines the ability to deliver the planned radiation dose accurately and to effectively plan and target the tumor using advanced imaging and robotic positioning systems. Secondary goals include measuring tumor response, survival outcomes, and quality of life. The treatment involves administering a drug called L-boronophenylalanine complexed with fructose intravenously over two hours before neutron irradiation. Each participant will receive two BNCT treatments spaced about four weeks apart. The nuBeam Suite, which includes a therapeutic neutron source and a patient positioning system with CT imaging, delivers a targeted neutron beam to the tumor area. The trial does not involve randomization and uses a dose escalation design with up to ten participants in three groups to assess safety. Participants will be closely monitored through various assessments including safety evaluations one month after the final treatment. Researchers will track adverse events, tumor response using imaging, and survival rates over time. The study includes detailed treatment planning, patient positioning, and follow-up visits to ensure accurate delivery of therapy and to evaluate outcomes such as duration of tumor response and progression-free survival. The entire research process is expected to last about 13 months, with participant enrollment anticipated to take 12 months.

Accelerator-based BNCT (Boron Neutron Capture Therapy) for Head and Neck Carcinoma.