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 (10)B-atoms are present. Neither the (10)B-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.
Department of Radiation Oncology, University Hospital Essen, University Duisburg-Essen, Hufelandstrasse 55, Essen, Germany. andrea.wittig@uni-due.de
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D000230:Adenocarcinoma / Q000378:metabolism / Q000532:radiotherapy / Q000556:secondary; D001894:Borohydrides / Q000493:pharmacokinetics / Q000627:therapeutic use; D001896:Boron Compounds / Q000493:pharmacokinetics / Q000627:therapeutic use; D016754:Boron Neutron Capture Therapy / Q000379:methods*; D002294:Carcinoma, Squamous Cell / Q000378:metabolism / Q000532:radiotherapy; D015179:Colorectal Neoplasms; D005260:Female; D006258:Head and Neck Neoplasms / Q000378:metabolism / Q000532:radiotherapy; D006801:Humans; D008113:Liver Neoplasms / Q000378:metabolism / Q000532:radiotherapy / Q000556:secondary; D008297:Male; D009369:Neoplasms / Q000378:metabolism / Q000532:radiotherapy*; D010649:Phenylalanine / Q000031:analogs & derivatives / Q000493:pharmacokinetics / Q000627:therapeutic use; D011446:Prospective Studies; D011838:Radiation-Sensitizing Agents / Q000493:pharmacokinetics / Q000627:therapeutic use; D013438:Sulfhydryl Compounds / Q000493:pharmacokinetics / Q000627:therapeutic use; D013964:Thyroid Neoplasms / Q000378:metabolism / Q000532:radiotherapy; D014018:Tissue Distribution
D001894:Borohydrides; D001896:Boron Compounds; D011838:Radiation-Sensitizing Agents; D013438:Sulfhydryl Compounds; C014651:mercaptoundecahydrododecaborate; D010649:Phenylalanine; C033685:4-boronophenylalanine