BNCT for skin malignancies

Phase 1

• Conditions: Advanced or recurrent skin malignancies; Skin malignancies, BNCT

• Registration Number: JPRN-jRCTs061180066
• 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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Study Completion: 2020-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1) With recurrent skin malignancies that surgical treatment is not indicated or is strongly rejected by patient.
2) The depth of tumor is less than 6cm
3) T/N ratio is more than 2.5 using 18F-BPA-PET.
4) Serum creatinine<=1.2mg/dl(male), 1.0mg/dl(female)
5) KPS>= 60 percentage

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor response in 6 months after BNCT

Secondary Outcome Measures

Name	Time	Method
Adverse events in 6 months after BNCT