jRCT2080224670已完成2 期
Phase II trial of the combination of SPM-011 and BNCT System for recurrent malignant glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 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
- 干预模型
- Multi-center, open label, single armed study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 74age old under（—）
- 性别
- All
入选标准
- •Karnofsky performance status of >=60
- •Patients treated with temozolomide and radiation therapy. Patients with relapse or exacerbation of malignant glioma by CT or MRI
- •Patients who underwent radiotherapy with a total dose of 50 Gy - 65 Gy with fractional radiation of about 2 Gy per day for the target lesion site
- •Patients having measurable lesion according to RANO criteria
排除标准
- •Patients with active multiple primary cancers
- •Patients with extracranial metastasis
- •Patients with meningeal or intrathecal dissemination or discontinuous two or more tumor lesions
- •Patients treated with Bevacizumab
结局指标
主要结局
-
efficacy 1-year survival rate
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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