Report on the First Patient Group of the European Phase I Trial (EORTC Protocol 11961) at the High Flux Reactor Petten

The first European clinical trial on BNCT (EORTC protocol 11961) started in 1997.1 Thjs is a phase I study, aimed to define the Maximum Tolerated Dose and Dose Limiting Toxicity in gliobastoma patients using BSH as boron carrier and fractionated radiation at the Epithermal Neutron Facility at Petten. Beside the evaluation of the systemic toxicity of BSH, and the early radiation toxicity in the irradiated volume, special emphasis has been placed on the late radiation morbidity. In addition survival will be observed. Up to this date 14 patients have been entered into the study, 12 males and 2 females at six Neurosurgery Centers in five European countries.