Newly-diagnosed glioblastoma boron, neutron, glioblastoma
Conditions
Interventions
- Intravenous administration of investigational drug
- Neutron irradiation of the clinical target volume with the investigational device
Sponsors
Sakurai Hideyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Karnofsky Performance Status is greater than 50. - Histologically diagnosed glioblastoma (IDH-wild glioblastoma WHO grade 4 according to WHO 2016 classification) (immunostaining negative for IDH-1) - Measurable target lesions by RANO criteria with the deepest contrast-enhanced lesion within 6 cm of the skin surface on postoperative contrast-enhanced MRI scan.
Exclusion criteria
Exclusion criteria: - Multiple lesions, bilateral lesions, disseminated lesions on MRI images - Significant postoperative symptoms of increased intracranial presure - Patients with severe systemic diseases - Patients who have a hitory of radiotherapy to the brain - Patients who meet the following criteria on clinical examination a) White blood cell count less than 3,500/mm3 b) Platelet count less than 7,5000/mm3 c) AST and ALT greater than 2.5 times the upper limit of the institutional standard d) Total bilirubin 1.5 times or more than the upper limit of the facility standard e) BUN 2.5 times or more than the upper limit of the facility standard f) Creatinine 1.5 times or more than the upper limit of the facility standard - Patients for whom contrast-enhanced MRI cannot be performed - Patients who cannot administrate temozolomide - Patients with ongoing convulsive seizures - Patients with active multiple cancers other than the target disease - Patients receiving or scheduled to receive bevacizumab - Pregnant women or patients who are unable to use contraception during the study period - Patients with phenylketonuria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence rate of dose-limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints - Safety and tolerability after BNCT - Measurements of clinical laboratory tests - Measurements of physical examination and other investigations Efficacy endpoints - Overall survival - Progression-free survival - Local control at 90 days after BNCT - KPS measurements and change from baseline - Neurological examination measurements and change from baseline - Tumor responce evaluation - Duration of response | — |
Contacts
Public ContactAkira Wakamatsu
University of Tsukuba
Outcome results
None listed