BNCT for head and neck malignancies

JRCT ID: jRCTs061180067

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Advanced or recurrent head and neck malignancies
• Date of first enrollment: 07/09/2017
• Target sample size: 40
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Tumor response in 6 months after BNCT
• Secondary Outcome: Adverse events in 6 months after BNCT

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

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)

Exclude criteria

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

Related Information

• Primary Sponsor: Kamitani Nobuhiko
• Secondary ID(s): 000027543