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

未提供0 个研究点目标入组 3 人开始时间: 2019年1月31日最近更新: 2021年6月3日

试验速览

阶段: 不适用
状态: 已完成
入组人数: 3
主要终点: Local control

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age old over 至 84age old under（—）
性别: All

入选标准

•1.Patients who are histopathologically diagnosed with angiosarcoma.
•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.
•The deepest lesion should be within 8 cm from the skin surface.
•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.
•Patients should be older than 20 and younger than 85 years old at informed consent.
•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.

排除标准

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

结局指标

主要结局

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.

次要结局

adverse events

研究者

发起方

未提供

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