Recurrent head and neck malignancies (HNM) are often radio-/chemo-resistant and show extensive growth, necessitating a wide resection including surrounding tissues. To avoid severe impairment of oro-facial structures and functions, it is necessary to explore new treatments for HNM. Boron neutron capture therapy (BNCT) is tumor-cell targeted radiotherapy that has significant superiority over conventional radiotherapies in principle. We report here, first in the world, six patients with a recurrent HNM who have been treated with BNCT. The BNCT in combination with boronophenylalanine (BPA) and borocaptate sodium (BSH) was performed using the epithermal neutrons with Kyoto University Research Reactor (KUR). The results of BNCT were as follows: (1) (10)B concentration of tumor/normal tissue ratios (T/N ratio) of PET studies were SCC:1.8-4.4, sarcoma:3.1-4.0, parotid tumor:3.5. (2) Relative volume (%) of each tumor to the prior were 6-46%. (3) Remarkable reduction (46-100%) of huge tumor such as 40-675 cm(3) (average: 315 cm(3)), improvement of QOL and very mild side effects were recognized in all cases. These results indicate that BNCT represents a new and promising treatment approach even for a huge or far advanced HNM. (C) 2004 Elsevier Ltd. All rights reserved.