臨床研究等提出・公開システム

Phase II clinical trial on clinical efficacy and safety of combination therapy of boron neutron capture therapy and bevacizumab for recurrent glioma with poor prognosis

(P2BNCTBforrMG)

Combination therapy of boron neutron capture therapy and bevacizumab for recurrent glioma with poor prognosis (P2BNCTBforrMG)

4

Case Age Gender Histology RPA class 001-001 63 male GBM class 7' 001-002 67 female GBM class 7 001-003 64 male GBM class 7 001-004 54 male GBM class 7' GBM:Glioblastoma, RPA:Recursive Partitioning Analysis

We canceled this clinical trial in the midway of the trial by the following reasons. 1) Company-lead clinical trial using accelerator-based BNCT begun simulatenously. 2) Kyoto University Research Reactor did not work stably and stopped the clinical BNCT activity at the end of February, 2020.

Alopecia grade 1 4/4 (100%) Hoarseness grade 1 1/4 (25%) Hiccup grade 1 1/4 (25%)

case OS PFS (days) (days) 001-001 214 115 001-002 503 275 (censored on Feb 18, 2020) 001-003 299 127 001-004 179 93 mean median SD range (days) OS 298.75 256.5 125.74 179-299 PFS 152.5 121 71.77 93-275 OS (days): Overall Survival, PFS:Progression-Free Survival

Three cases out of 4 were dead and 1 case is still alive at the date of censored. BNCT and additive bevacizumab could prolong all 4 recurrent, with poor-prognoses glioma cases with the reference with RPA classification. (Original RPA class 7 cases showed 4.9 months as median survival after recurrence). No brain radiation necrosis occurred with bevacizumab treatment.

April. 23, 2021

No

N/A

https://jrct.niph.go.jp/latest-detail/jRCTs051180218

Miyatake Shin-Ichi

Affiliation: Osaka Medical College , Kansai BNCT Medical Center, Medical Institution: Osaka Medical College Hospital

2-7 Daigakumachi, Takatsuki, Osaka

neu070@osaka-med.ac.jp

Miyatake Shin-Ichi

Osaka Medical College

2-7 Daigakumachi, Takatsuki, Osaka

+81-72-863-1221

neu070@osaka-med.ac.jp

Complete

Oct. 01, 2017

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

See the attached file.

See the attached file.

Both

recurrent glioma with poor prognosis

Protocol treatments consist of BNCT, additional and chemotherapy with bevacizumab. Prescription dose by BNCT is regulated as not to be more than 13 Gy-Eq for normal brain. Additional bevacizumab is given biweekly with 10 mg/kg as long as progressive disease judged by RANO criteria.

Overall survival OS
It is defined as the period from the treatment start date to the death date due to any cause. In surviving cases, we will terminate halfway with the date of final survival confirmation. In the case of non-follow-up cases, we aborted by the last day that survival was confirmed before becoming impossible to pursue.

PFS by RANO standard
It is defined as the period from the treatment start date to the day when the progression of disease (PD) based on the RANO standard, or until the death date due to any cause. In cases that did not deteriorate, we abort halfway with the final progression-free evacuation date (the date of making a decision other than deterioration). In the case of non-follow-up cases, we abort halfway with the final progression-free confirmation date before becoming impossible to pursue.

Expression of adverse events
Evaluate adverse events and serious adverse events that occurred during treatment or within 30 days after the end of treatment. Observed adverse events are evaluated based on Common Toxicity Criteria for Adverse Events v4.0 (CTCAE v4.0).

+81-72-684-6760

Mar. 01, 2019

none