title: Case numbers for a randomized clinical trial of boron neutron capture therapy for Glioblastoma multiforme.
abstract: 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.
authors.affiliation: Kompetenzzentrum Klinische Studien KKS, Bremen, Germany; Cooperative Center Medicine, University of Bremen, Bremen, Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Sander
authors.affiliation: Kompetenzzentrum Klinische Studien KKS, Bremen, Germany; Cooperative Center Medicine, University of Bremen, Bremen, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Wosniok
authors.affiliation: Department of Chemistry, University of Bremen, Bremen, Germany; Cooperative Center Medicine, University of Bremen, Bremen, Germany; School of Engineering and Science, Jacobs University Bremen, Campus Ring 1, D-28759 Bremen, Germany. Electronic address: d.gabel@jacobs-university.de.
authors.forename: Detlef
authors.initials: D
authors.lastname: Gabel
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use; D001894:Borohydrides / Q000627:therapeutic use; D001896:Boron Compounds / Q000627:therapeutic use*; D016754:Boron Neutron Capture Therapy / Q000401:mortality*; D001932:Brain Neoplasms / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D059248:Chemoradiotherapy / Q000401:mortality; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005858:Germany / Q000453:epidemiology; D005909:Glioblastoma / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010649:Phenylalanine / Q000031:analogs & derivatives / Q000627:therapeutic use; D015995:Prevalence; D012307:Risk Factors; D015996:Survival Rate; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: C436045:4-dihydroxyborylphenylalanine; D018906:Antineoplastic Agents, Alkylating; D001894:Borohydrides; D001896:Boron Compounds; D010649:Phenylalanine; D003606:Dacarbazine; C025364:sodium borohydride; D000077204:Temozolomide
keywords: BNCT; BPA; BSH; Design of clinical trials; Glioblastoma