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

Anja Sander, Werner Wosniok, Detlef Gabel

Journal: Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine 2015;88():16-9

PMID: 24373823

Full Text on Elsevier Science View on PubMed

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.

Address: Kompetenzzentrum Klinische Studien KKS, Bremen, Germany; Cooperative Center Medicine, University of Bremen, Bremen, Germany.; 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: [email protected].

DOI: 10.1016/j.apradiso.2013.11.092

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MeSH Terms: Adult, Aged, Antineoplastic Agents, Alkylating, Borohydrides, Boron Compounds, Boron Neutron Capture Therapy, Brain Neoplasms, Chemoradiotherapy, Dacarbazine, Female, Germany, Glioblastoma, Humans, Male, Middle Aged, Phenylalanine, Prevalence, Risk Factors, Survival Rate, Temozolomide, Treatment Outcome