Status Report on the European Clinical Trial of BNCT at Petten (EORTC Protocol 11961)

Abstract

In October 1997, after a preparatory phase of 8 years, the first patient in Europe was treated by BNCT at the High Flux Reactor (HFR) of the European Commission in Petten, The Netherlands.1 The preparation for the first clinical BNCT trial in Europe included comprehensive scientific experimental and human investigations with the boron compound borocaptate sodium (BSH).2,3 A multitude of open legal and administrative questions had to be overcome. Furthermore a complex structure had to be organized and the procedures had to be defined how to perform a multi-national, multi-institutional study using a nuclear reactor distant from hospital for patient treatment performed by an international team on a multidisciplinary base.4 The international standards of clinical research as well as the accepted rules and definitions of conventional radiotherapy were applied, involving independent experts in order to assure the quality of the study and the quality of the Performance of patient treatment. The goal was to execute the project to a very high Standard as would be expected in the leading radiotherapy depart-ments in Europe.5