Case numbers for a randomized clinical trial of boron neutron capture therapy for Glioblastoma multiforme

• BNCT of Glioblastoma with BPA is not more effective than RT+TMZ.
• BNCT of Glioblastoma with BSH is probably more effective than RT+TMZ.
• A clinical trial with patients of class V and an unmethylated MGMT gene should be conducted.

Boron neutron capture therapy (BNCT) with Na2B12H11SH (BSH) or p-dihydroxyborylphenylalanine (BPA), and with a combination of both, was compared to radiotherapy with temozolomide, and the number of patients required to show statistically significant differences between the treatments was calculated. Whereas arms using BPA require excessive number of patients in each arm, a two-armed clinical trial with BSH and radiotherapy plus temozolomide is feasible.