Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- quality of life EORTC QLQ C30
研究概览
简要总结
Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion.
second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol
详细描述
A patient with a brain metastasis may have the choice between surgery and focal radiosurgery of the surgical site and only hypofractionned radiosurgery on the lesion.
No previous study has focused on quality of life regarding these two treatments options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •eligible for both treatments options OMS status <3 primary cancer with no evolution brain metastasis < 3cm ou giving symtoms patient with informed consent patient affilated to french social security
排除标准
- •OMS > 3 More than 3 brain metastasis brain metastasis already treated with hypofractionned radiosurgery
结局指标
主要结局
quality of life EORTC QLQ C30
时间窗: change between baseline and 6 month
score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30
次要结局
- neuro cognitive evaluation(12 and 24 month)
- local control of the desease(baseline up to 24 month)
- overall survival(24 month)
- survival without progression(24 month)
- medico economic evaluation(24 month)