jRCT2051210053已完成不适用
An open label dose escalation study to investigate the safety and tolerability of boron neutron capture therapy (BNCT) with SPM-011 and BNCT treatment system (BNCT30) in patients with recurrent malignant glioma (WHO grade III and grade IV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- -
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 75age old not（—）
- 性别
- All
入选标准
- •Karnofsky performance status >= 60
- •Patients with recurrent malignant glioma confirmed by imaging or histological diagnosis with previous radiotherapy to the target lesion.
- •Patients who have received 50 Gy to 65 Gy of prior radiation therapy to the target lesion and more than 180 days have passed since the last irradiation.
排除标准
- •Patients with active multiple primary cancers
- •Patients with meningeal dissemination or two or more discontinuous tumor lesions
- •Patients who are using steroids other than for the treatment of cerebral edema or who have complications requiring systemic administration of steroids
结局指标
主要结局
-
Safety, tolerability
次要结局
未报告次要终点
研究者
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