The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- a- Response rate
研究概览
简要总结
The purpose of the study is to evaluate the effect of simvastatin in combination with radiotherapy on the clinical outcomes of patients with brain metastases.
详细描述
Despite current advances in therapies, the outcome for patients with brain metastases is fatal. New therapeutic approaches, such as radiosensitizing agents, are needed to provide a significant survival advantage for those patients. Statins have been reported to enhance the efficacy of radiotherapy in addition to a neuroprotective effect. The aim of the study is to evaluate the effect of simvastatin on the efficacy and safety of radiation therapy in patients with brain metastases and on improving patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with measurable brain metastases
- •Age more than 18 years old
- •Patients should be planned for radiation therapy
排除标准
- •Renal dysfunction (more than 1 upper normal level)
- •Hepatic dysfunction (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3 times the upper normal level )
- •Pregnancy or lactation.
- •Known hypersensitivity to simvastatin
研究组 & 干预措施
simvastatin
they will receive simvastatin in addition to radiation therapy
干预措施: simvastatin in addition to radiation therapy (Drug)
control
they will receive radiation therapy only
干预措施: radiation therapy (Radiation)
结局指标
主要结局
a- Response rate
时间窗: 4 weeks after radiation therapy
brain CT/MRI will be done at baseline and 4 weeks after radiotherapy to evaluate the reduction in tumor size
次要结局
- progression free and overall survival(up to 6 months)
- adverse effects(during the treatment period)
研究者
MAy Ahmed Shawki
teaching assisstant
Ain Shams University