The Effect of Thalidomide in Radiation-induced Brain Injury（RI）: a Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- the brain injury remission
研究概览
简要总结
Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in radiation-induced brain injury.
Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang.
Primary outcome measure: The primary endpoint is the brain injury remission at week 15. In brief, the brain lesion will be evaluated by using brain MRI scan before and after thalidomide regimen. The clinical efficacy is defined as ≥ 25% reduction in brain edema volume on FLAIR images at week 15, as compared with that before thalidomide usage.
详细描述
There is no acknowledged and effective standard treatment for radiation-induced brain injury (RI). Glucocorticoids and bevacizumab during acute period are optional ways to reduce the brain edema. However, glucocorticoids and bevacizumab are unsuitable or ineffective for some patients, especially in the early stage of RI. The investigators supposed that angiogenesis might play a key role in the pathogenesis of RI, and that thalidomide, as an antiangiogenic drug, would reduce immature angiogenesis and improve vessel maturation in RI.
Primary objectives: This phase II clinical trial aims to evaluate the indications, therapeutic effects and safety of thalidomide in radiation-induced brain injury.
OUTLINE: This is a phase II, open-label, single arm clinical trial. Patients are enrolled and administrated with thalidomide. Thalidomide is supplied as 25 mg per pill to be taken by mouth.
Arm І: Patients receive thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
thalidomide
Thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration.
干预措施: Thalidomide (Drug)
结局指标
主要结局
the brain injury remission
时间窗: Week 15
The brain injury remission is defined as ≥ 25% reduction in brain edema volume on FLAIR images at week 15, as compared with that before thalidomide usage
次要结局
- improvement of quality of life(Week 15)
- improvement of neurological function(Week 15)
研究者
Yamei Tang
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University