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BNCT for head and neck malignancies

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061180067
Enrollment
40
Registered
2019-03-19
Start date
2017-09-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or recurrent head and neck malignancies Head and neck malignancies, BNCT

Interventions

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 prom

Sponsors

Kamitani Nobuhiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Tumor response in 6 months after BNCT

Secondary

MeasureTime frame
Adverse events in 6 months after BNCT

Contacts

Public ContactNobuhiko Kamitani

Kawasaki Medical School Hospital

kamitaninobuhiko@gmail.com+81-86-462-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026