Early clinical trial concept for boron neutron capture therapy: A critical assessment of the EORTC trial 11001

BNCT causes selective damage to tumor cells by neutron capture reactions releasing high LET-particles where 10B-atoms are present. Neither the 10B-compound nor thermal neutrons alone have any therapeutic effect. Therefore, the development of BNCT to a treatment modality needs strategies, which differ from the standard phase I–III clinical trials. An innovative trial design was developed including translational research and a phase I aspect. The trial investigates as surrogate endpoint BSH and BPA uptake in different tumor entities.