JPRN-jRCT2080224670已完成2 期
Phase II trial of the combination of SPM-011 and BNCT System for recurrent malignant glioma
STELLA PHARMA CORPORATIO0 个研究点目标入组 27 人开始时间: 2019年5月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
研究概览
简要总结
The 1-year survival rate was 79.2% (95% CI: 57.0-90.8) and the median OS (mOS) was 18.9 months (12.9-not estimable) with BNCT.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •1. Karnofsky performance status of >=60
- •2. Patients treated with temozolomide and radiation therapy. Patients with relapse or exacerbation of malignant glioma by CT or MRI
- •3. 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
- •4. Patients having measurable lesion according to RANO criteria
排除标准
- •1. Patients with active multiple primary cancers
- •2. Patients with extracranial metastasis
- •3. Patients with meningeal or intrathecal dissemination or discontinuous two or more tumor lesions
- •4. Patients treated with Bevacizumab
研究者
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