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

Wolfgang Sauerwein, Ray Moss, Jürgen Rassow, Finn Stecher-Rasmussen, Katalin Hideghéty, John G. Wolbers, Horst Sack

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Boron Neutron Capture Therapy is based on the ability of the isotope 10B to capture thermal neutrons and to disintegrate instantaneously producing high LET particles. The only neutron beam available in Europe for such a treatment is based at the European High Flux Reactor HFR at Petten (The Netherlands). The European Commission, owners of the reactor, decided that the potential benefit of the facility should be opened to all European Citizens and therefore insisted on a multinational approach to perform the first clinical trial in Europe on BNCT. This precondition had to be respected as well as the national laws and regulations. Together with the Dutch authorities actions were undertaken to overcome the obvious legal problems. Furthermore, the clinical trial at Petten takes place in a nuclear research reactor, which apart from being conducted in a non-hospital environment, is per se known 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 staff. In itself, the trial is an unusual Phase I study, introducing a new drug with a new irradiation modality, with really an unknown dose-effect relationship. This trial must follow optimal procedures, which underscore the quality arid qualified manner of performance.

Original languageEnglish
Pages (from-to)108-111
Number of pages4
JournalStrahlentherapie und Onkologie
Volume175
Issue numberSUPPL. 2
Publication statusPublished - Jun 1 1999

Keywords

  • BSH
  • Boron Neutron Capture Therapy BNCT
  • EORTC
  • Glioblastoma multiforme
  • High Flux Reactor HFR
  • Phase I trial
  • Quality assurance

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Oncology

Fingerprint Dive into the research topics of 'Organisation and management of the first clinical trial of BNCT in Europe (EORTC Protocol 11961)'. Together they form a unique fingerprint.

  • Cite this

    Sauerwein, W., Moss, R., Rassow, J., Stecher-Rasmussen, F., Hideghéty, K., Wolbers, J. G., & Sack, H. (1999). Organisation and management of the first clinical trial of BNCT in Europe (EORTC Protocol 11961). Strahlentherapie und Onkologie, 175(SUPPL. 2), 108-111.