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

This phase I study of an accelerator-based boron neutron capture therapy (BNCT) in the treatment of locally recurrent head and neck carcinoma, is sponsored by HUS, Haartmaninkatu 4, Helsinki, Finland and Neutron Therapeutics Finland OY, Kanavaranta 9 FIN-00290 Helsinki. The indication is for patients with head and neck carcinoma that has recurred locally after conventional radiation therapy. The primary objective is to demonstrate the safety of accelerator-based neutron radiation using the nuBeam Suite in delivering BNCT. The secondary objective is the ability to deliver the planned radiation dose to the target site and the ability to plan the trial treatment using the trial treatment planning software, position and target the tumor site using the robotic table in conjunction with the CT scanner and calculate the required radiation dose for each planned BNCT trial treatment. To establish these objectives, the following parameters will be controlled: * Objective response rate * Duration of response. * The clinical benefit rate (includes complete response, partial response, and stabilized disease for a minimum of 8 weeks since the date of the first BNCT). * Locoregional recurrence-free survival. * Progression-free survival. * Overall survival. * Quality of life. The maximum sample size is 10 study subjects evaluable for safety. The study does not involve randomization. Regarding the target population, the study subjects must fulfill each of the inclusion criteria: 1. Patient has provided a written informed consent as approved by the EC prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. 2. ≥ 18 years of age at the time of enrollment. 3. Histologically confirmed head and neck carcinoma. 4. Inoperable cancer, prior surgery may or may not have been done. 5. Prior radiotherapy or chemoradiotherapy has been given. 6. Anticipated life expectancy of at least 6