Boron neutron capture therapy for treatment-refractory angiosarcoma

JRCT ID: jRCTs051180217

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: treatment-refractory angiosarcoma
• Date of first enrollment: 31/01/2019
• Target sample size: 3
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

Primary Outcome

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.

• Secondary Outcome: 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).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 84age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Miyatake Shin-Ichi
• Secondary ID(s): UMIN000029401