A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The primary endpoint of this study is to evaluate the 6 month and 1 year local control rate for 1-3 brain metastases treated with intracavitary radiation therapy.
研究概览
简要总结
This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.
详细描述
Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. In this case, it will irradiate the resected margins. Brain metastases not surgically removed will be then treated with radiosurgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced MRI scan
- •Have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report
- •Have a Karnofsky Performance Status (KPS) >=70
- •Have systemic disease which is judged to be stable and has been staged within the last 6 weeks
- •Have a life expectancy of >= 6 month, based upon extent of systemic disease
- •Be at least 18 years of age Give informed consent (or have legal representative give informed consent)
排除标准
- •Be receiving or have plans to receive conventional or investigational systemic agents for the metastatic brain tumor.
- •Be receiving or have plans to receive external beam radiation therapy to the brain.
- •Have received prior conventional or investigational systemic agents, including the use of Gliadel Wafers or Temodar, for the treatment of the brain metastasis.
- •Be pregnant or breast-feeding.
- •Have uncontrolled hypertension, unstable angina pectoris, evidence of uncontrolled cardiac dysrhythmia.
- •Have other serious concurrent infection or other medical illness which would jeopardize the ability of the patient to safely undergo resection and brachytherapy.
- •Have histology of lymphoma or small-cell lung cancer.
结局指标
主要结局
The primary endpoint of this study is to evaluate the 6 month and 1 year local control rate for 1-3 brain metastases treated with intracavitary radiation therapy.
时间窗: Data collected at the time of implant, within 72 hours of implant, pre-brachytherapy, brachytherapy, radiosurgery, 1 and 3 months post brachytherapy and every 3 months thereafter
次要结局
- Overall survival, distant brain recurrence, toxicity and quality of life.(Survival)