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BNCT phaseI / II clinical trial for recurrent head and neck malignancies (BNCT for H & N malignancies)

BNCT for head and neck malignancies (BNCT for H & N malignancies)

21

refractory head and neck carcinoma

Although this research did not recognize as a specific clinical research, we treated with BNCT in the institute for integrated radiation and nuclear science at Kyoto university during The research period permitted by ethical guidelines. The study was discontinued in March 2020 because the accelerator BNCT was approved for medical treatment.

There has been no patient with more than Grade 3 except for one patient with renal failure cause of tumor-related dehydration.

Tumor control rate (CR+PR):61.9% Adverse event: There has been no patient with more than Grade 3 except for one patient with renal failure cause of tumor-related dehydration.

The findings in our clinical trials indicate that BNCT is effective against a recurrent cancer after conventional therapies, if BPA accumulates sufficiently in the tumor.

Mar. 31, 2021

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs061180067

Kamitani Nobuhiko

Kawasaki Medical School Hospital

577 Matsushima, Kurashiki, Okayama

kamitaninobuhiko@gmail.com

Kamitani Nobuhiko

Kawasaki Medical School Hospital

577 Matsushima, Kurashiki, Okayama

+81-86-462-1111

kamitaninobuhiko@gmail.com

Complete

Sept. 07, 2017

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) With recurrence head and neck melanoma that surgical treatment is not indicated.
2) The depth of tumor, less than 6cm, and without distant metastases.
3) T/N ratio is more than 2.5 using 18F-BPA-PET.
4) KPS>= 60 percentage
5) Serum creatinine<=1.2mg/dl(male), 1.0mg/dl(female)

1) Double cancer with disease-free period less than 3 years
2) Distant metastases
3) Active infection
4) Adverse events mere than Grade 3 induced by previous therapy
5) Tumor exposure to the skin and tumor invasion to the carotid artery
6) Severe heart complications
7) Difficulty of patient fixation for irradiation
8) White blood cell<=3000/mm3, Platelet<=100,000/mm3
9) Unsuitable patients for medical or social situation

Both

Advanced or recurrent head and neck malignancies

1) Intravenous administration of BPA-fructose complex (500mg/Kg.BW) for 2.5 to 3 hour and blood sampling at the time of just before irradiation. The 10B concentration in the blood was measured by prompt gamma ray spectrometry.
2) Optimization of the neutron dose based on the measured blood 10B concentration and neutron flux. As the therapeutic dose, the maximum tolerable dose to the mucosa itself is chosen. Our limitation dose is not to excess the tolerable dose to mucosa. It is less than 15 Gy-eq.

Head and neck malignancies, BNCT

Tumor response in 6 months after BNCT

Adverse events in 6 months after BNCT

+81-86-464-1547

Mar. 11, 2019

none