Organisation and management of the first clinical trial of BNCT in Europe (EORTC protocol 11961)

Boron Neutron Capture Therapy is based on the ability of the isotope B-10 t o capture thermal neutrons and to disintegrate instantaneously producing hi gh LET particles. The only neutron beam available in Europe for such a trea tment is based at the European High Flux Reactor HFR at Petten (The Netherl ands). The European Commission, owners of the reactor, decided that the pot ential benefit of the facility should be opened to all European citizens an d therefore insisted on a multinational approach to perform the first clini cal trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities a ctions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, wh ich apart from being conducted in a non-hospital environment, is per se kno wn to be dangerous. It was therefore of the utmost importance that special attention is given to safety, beyond normal rules, and to the training of s taff. In itself, the trial is an unusual Phase I study, introducing a new d rug with a new irradiation modality, with really an unknown dose-effect rel ationship. This trial must follow optimal procedures, which underscore the quality and qualified manner of performance.