NCT03286023Unknown不适用
Stereotactic Radiotherapy for Patients With Brain Metastases
Centre Francois Baclesse, Luxembourg1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Evaluation of tumoral response
研究概览
简要总结
Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Situation 1: in case of several cerebral metastases. In this case, the maximum of cerebral metastases is 3, and the maximum diameter of the largest can not exceed 3 cm. The other two ones can not exceed 1 cm or even maximum 2 cm in diameter for one of the two. The same principle will remain valid in the presence of 2 metastases.
- •Situation 2: in the case of a single metastasis, the diameter should be a maximum of 3 cm
- •Situation 3: in case of metastasis supposed to be radioresistant (renal adenocarcinoma, sarcoma, melanoma ...), only a single metastasis of not more than 3 cm in diameter will be accepted. A primary resection followed by radiotherapy will be preferred.
- •Situation 4: In case of localization near a structure at risk (contact with anterior optical pathways, central nuclei or the brainstem or localization in these structures), a maximum number of 3 metastases may be accepted. However, that included in or close to the risk structure can not exceed 2 cm in diameter and the other two, located outside a risk structure will have a diameter not exceeding 1 or even maximum 2 cm.
- •Situation 5: single metastasis of maximum 3 cm in a context of re-irradiation, the whole encephalon having already received the dose of 10 X 3 Gy or its biological equivalent of dose.
- •Signed informed consent
排除标准
- •Impossibility of performing an MRI or a CT-scan of the brain with injection of contrast agent
- •Metastases greater than 3 cm at the start
结局指标
主要结局
Evaluation of tumoral response
时间窗: 8 weeks after treatment
Evaluation of response using Magnetic resonance imaging (Recist criteria)
次要结局
- Evaluation of toxicity(1, 3, 6, 9, 12, 15 months after treatment)
研究者
研究点 (1)
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