Boron neutron capture therapy for treatment-refractory angiosarcoma

Phase 2

• Conditions: treatment-refractory angiosarcoma

• Registration Number: JPRN-jRCTs051180217
• Lead Sponsor: Miyatake Shin-Ichi

Brief Summary

BNCT could locally control the lesion transiently locally in two cases of angiosarcoma.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Study Completion: 2020-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1.Patients who are histopathologically diagnosed with angiosarcoma.
2. Patients who have the relapsed inoperable lesion, without lymph node or systemic metastasis or newly diagnosed angiosarcoma judged as inoperable or patients who refuses the operation.
3. The deepest lesion should be within 8 cm from the skin surface.
4. Patients with bone marrow, liver, kidney function satisfying the following conditions within 28 days before enrollment
Leukocyte count 3,000 /microlitter or more, Hemoglobin 8.0 g/dL or more, Platelet count 100,000 /microlitter or more, AST 100 IU/L or less, ALT 100 IU/L or less, Total bilirubin 1.5 mg/dL or less, Serum creatinine 1.2 mg/dL or less, albumin 3.5mg/dL or more, LDH 240IU/L or less.
5. Patients should be older than 20 and younger than 85 years old at informed consent.
6. A lesion can be treatable as a new one, which did not exist at the previous BNCT treatment and appeared at the out of field of previous neutron irradiation, during observation period.

Exclusion Criteria

1.Complication of congestive heart failure of 3 degree or more in NYHA
2. Patients who have systemic metastasis.
3. Patients scheduled for surgery during the study or patients under 4 weeks from surgical therapy
4. Pregnant woman or lactating woman
5.Patients with infectious disease necessary to be treated
6. Patients with phenylketonuria
7. Patients who have mental illness and judged as difficult for participation of this clinical trial.
8.Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons.
9. In-field re-appeared lesion is a recuurence and should not be a target lesion by additional BNCT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified