NCT02032147已完成不适用
Treatment of Cerebral Radiation Necrosis (CRN) With Nerve Growth Factor (NGF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- efficacy of using NGF for treating CRN
研究概览
简要总结
Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF) to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective study to test the efficacy of NGF for CRN.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months.
排除标准
- •CRN combined with local or regional relapse, or with distant metastasis.
- •CRN combined with other cerebrovascular disease.
- •CRN combined with the second primary malignancy.
- •CRN without neurologic symptoms or signs.
- •CRN combined with diabetes.
- •CRN patients that were supposed to live less than 6 months.
研究组 & 干预措施
NGF group
This group will be treated with NGF 18u daily for 60 days.
干预措施: NGF group (Drug)
结局指标
主要结局
efficacy of using NGF for treating CRN
时间窗: 6-8 months
次要结局
未报告次要终点
研究者
研究点 (1)
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