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BNCT for head and neck malignancies

Phase 1
Conditions
Advanced or recurrent head and neck malignancies
Head and neck malignancies, BNCT
Registration Number
JPRN-jRCTs061180067
Lead Sponsor
Kamitani Nobuhiko
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
21
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Tumor response in 6 months after BNCT
Secondary Outcome Measures
NameTimeMethod
Adverse events in 6 months after BNCT
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