Skip to main content
. 2024 Feb 15;14(2):429–447. doi: 10.62347/HBBE6868

Table 1.

Clinical trials of BNCT in brain and central nervous system tumor

Time Cancer Type Trial ID Phase Case Drug Maximum Dose of Radiation Outcomes (OS1/MST2) Citation
Registered Clinical Trials
    1999-2001 sGB3 NCT00115453 I/II 18 290-400 mg BPA4/kg 61.0 Gy(W)5 1y OS rate: 61% [14]
    2001-2009 GB6 NCT00115440 I/II 3 290 mg BPA/kg 29.0 Gy(W) 3m OS rate: 100% [14]
    2002-2003 GBM7 NCT00004015 I N/A 100 mg BSH8/kg N/A N/A [17-19]
    2002-2005 GBM NCT00039572 I/II 21 350 mg BPA/kg / N/A [20]
    2002-2006 GBM NCT00974987 II 21 BSH## 200 mg BPA/kg 13.0 Gy-Eq9 MST: 15.6 months [29]
    2007-2013 Glioma NCT01233492 I 2 350 mg BPA/kg / N/A [21]
    2009-2018 GB UMIN000002385 II 45# BPA## 13.0 Gy-Eq N/A [22]
    2014-2016 Glioma UMIN000013419 I/II 50# BPA## 13.0 Gy-Eq N/A [23]
    2019-2020 GBM jRCTs051180218 II 4 BPA## 13.0 Gy-Eq OS rate: 75% [24]
    2019- MG10 jRCT2051190044 II 46# 400 mg BPA/kg 7.5 Gy-Eq N/A [38]
    2022- Glioma NCT05737212 I/II 39# 500 mg BPA/kg 13.0 Gy-Eq N/A [30]
    2022- BM11 ChiCTR2200066473 I/II 6# 500-750 mg BPA/kg N/A N/A [40]
Investigator-initiated Clinical Trials
    1951-1961 GBM N/A I/II 28 ~200 mg 10B borax/kg 10.0 Gy-Eq N/A [10]
    1968-1996 Glioma N/A I/II 149 BSH## N/A 2y OS: 12% (GB), 56% (AA12), 62% (low grade astrocytoma) [11]
MST: 21.3 months (GB), 60.4 months (AA), 55.6 months (low grade astrocytoma)
    1994-1999 GBM N/A I/II 53 BPA## N/A MST: 12.8 months [12]
    1996-1999 GBM N/A I/II 20 BPA## N/A MST: 11.1 months [12]
    1997-2002 GBM N/A I/II 29 100 mg BSH/kg N/A MST: 10.4-13.2 months [13]
    1998-2007 GB N/A I/II 15 5 g BSH/body N/A MST: 25.7 months [25]
250 mg BPA/kg
    1998-2008 GB N/A I/II 23 100 mg BSH/kg 59.7 Gy(W) MST: 19.5 months; 1y OS: 60.6%; 2y OS: 37.9% [26]
250 mg BPA/kg
    1999-2002 Glioma N/A I/II 9 100 mg BSH/kg 15.9 Gy MST: 23.2 months (GB), 25.9 months (AA) [27]
    2000-2002 GBM N/A I 5 100 mg BSH/kg 14.2 Gy-Eq N/A [15]
    2001-2005 GB N/A I/II 42 900 mg BPA/kg 15.5 Gy(W) MST: 17.7 months (nGBM13), 22.2 months (rGBM14) [16]
    2002-2007 Glioma N/A I/II 22 100 mg BSH/kg 13.0 Gy-Eq MST6: 10.8 months [28]
500-700 BPA/kg
    2020-2022 MG N/A II 4 500 mg BPA/kg 29.4 Gy-Eq N/A [39]
1

OS: overall survival;

2

MST: median survival time;

3

sGB: supratentorial glioblastoma;

4

BPA: boronophenylalanine;

5

Gy(W): the absorbed dose of radiation considering biological effects;

6

GB: glioblastoma;

7

GBM: glioblastoma multiforme;

8

BSH: sodium borocaptate;

9

Gy-Eq: Gray Equivalent;

10

MG: meningioma;

11

BM: brain malignancy;

12

AA: anaplastic astrocytoma;

13

nGBM: none-recurrent GBM;

14

rGBM: recurrent GBM;

#

Number of patients panned to recruit in the registered information for ongoing trials or trials not yet updated after its predicted completion date.

##

The drug dosage is not reflected in the literature.