A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status
研究概览
简要总结
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases
详细描述
OBJECTIVES:
Primary
- To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.
Secondary
- To determine the overall survival rate at 6 months.
- To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.
- To determine the time to neurological death, time to systemic death, and Karnofsky decay time.
- To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans.
- •Have cancer not originating in central nervous system (CNS)
- •Karnofsky score of at least 60
- •Given written consent
- •At least 18 years of age
排除标准
- •Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial.
- •Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.
结局指标
主要结局
Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status
时间窗: Up to 5 years
Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.
次要结局
- Karnofsky Decay Time(From time of enrollment up to 5 years)
- Time to Systemic Death(From time of enrollment up to 5 years)
- Progression-free Survival (PFS)(Up to 5 years)
- Time to Neurological Death(From time of enrollment up to 5 years)
研究者
Mario Ammirati
Principal Investigator
Ohio State University Comprehensive Cancer Center