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Pilot clinical study of boron neutron capture therapy on treatment-refractory angiosarcoma (BNCTonrAS)

Boron neutron capture therapy for treatment-refractory angiosarcoma (BNCTonrAS)

2

Two cases of refractory angiosarcoma, recurred after PTX chemotherapy were treated with reactor-based BNCT. Case 1: 71 y.o., male, KPS 90% The lesions existed at left face, chest and upper abdomen. Case 2: 78 y.o., female, KPS 90% The lesions existed at left side of the head and face.

At the beginning of this trial, 3 cases were planned to be registered. However, Kyoto University research rector did not work stably and stopped to work at the end of February, 2020. We canceled this clinical trial in the midway of the planned study period. Therefore only 2 cases were registered in this trial and they were completed for protocol treatment and full follow-up.

Hair loss, keratoconjunctivitis, lagophthalmos, glossitis, mouth ulcer, and malaise occurred, including pigmentation of the irradiated area

As for local evaluation, it was difficult to measure RECIST by lesion X-ray CT, so area measurement using clinical photographs was used. Compared with the time of screening, pigmentation at the irradiation site was observed, and although no recurrence was observed at the same site, progression / expansion to the surrounding skin was observed, so both cases were evaluated as PD 6 months after irradiation.

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

May. 21, 2021

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs051180217

Miyatake Shin-Ichi

(Affiliation) Osaka Medical College Kansai BNCT Medical Center, (Medical Institution) Osaka Medical College Hospital

2-7 Daigakumachi, Takatsuki, Osaka

neu070@osaka-med.ac.jp

Miyatake Shin-Ichi

Osaka Medical College Kansai BNCT Medical Center

2-7 Daigakumachi, Takatsuki, Osaka

+81-72-683-1221

neu070@osaka-med.ac.jp

Complete

Oct. 10, 2017

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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.

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.

Both

treatment-refractory angiosarcoma

BNCT for patients with recurrent or surgically untreatable newly diagnosed angiosarcoma of the skin is applied by nuclear reactor. Two fields and one filed BNCT will be applied for angiosarcoma of scalp and that in other regions, respectively. Water-equivalent bolus, 10-20mm in thickness should be used in neutron irradiation. Neutron irradiation time is decided to apply 1.5 x 10+E12 n/cm2 neutron as flux.

Local control:
The lesions should be photographed with measures, periodically. Major and minor axis should be recorded and products should be calculated. The effects are judged as CR(complete disappearence), PR(more than 50% reduction by 2D product), SD (between less than 50% reductiion and less than 25% increase by 2D product) and PD (more than 50% increase by 2D product) for the assessment of local control, based on Macdonald criteria. Skin biopsy should be performed to confirm the effect of BNCT and tumor recurrence, as scheduled.

Evaluate adverse events and serious adverse events. Observed adverse events are evaluated based on Common Toxicity Criteria for Adverse Events v4.0 (CTCAE v4.0).

+81-72-684-6760

Mar. 01, 2019

none