RTID-06. A RANDOMIZED CONTROLLED TRIAL USING ACCELERATOR-BASED BNCT SYSTEM FOR REFRACTORY RECURRENT HIGH-GRADE MENINGIOMA

Abstract BACKGROUNDS Recently, nuclear reactors have been replaced with accelerator-based neutron sources (ABNS) for boron capture therapy (BNCT). High-grade meningiomas (HGM) are refractory, especially recurred after some radiotherapy. We now applying randomized controlled trial (RCT) of “A phase II clinical using BNCT system refractory recurrent high-grade meningioma”. STUDY DESIGN PMDA in Japan which is a counter part FDA USA suggested the importance RCT even this exploratory HGM. Along to suggestion, we prepared 2 study groups, test treatment group and control best supportive care (BSC) group. Progression free survival (PFS) was set-up as primary endpoint. Rescue allowed patients, if they showed progress disease (PD) during observation. Two-dimensional modified Macdonald criteria adopted assessment. METHODS The started August 2019. Eighteen subjects were enrolled divided 12 6 BSC group, respectively. Cyclotron-based ABNS used source. Neutron-irradiation time determined not exceed 7.5 Gy-Eq scalp dose referencing preceding I malignant gliomas. last patient-in 2021. INTERIM RESULTS (as April 30, 2022): All cases judges PD. Seven out 11 judged One case dropped from withdrawal consent. Median PFS 8 64 weeks Log-rank marked statistical difference p-value 0.000401 between these groups. CONCLUSIONS This so far. will keep on observation at least next years other endpoints.