Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- Quality of Life Survey (symptoms and interference)
研究概览
简要总结
This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)
详细描述
This research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life.
In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently published studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. It also yields better quality of life in this population. It remains unknown whether stereotactic radiation improves quality of life in patients with 5-20 brain metastases relative to whole brain radiation. In this study, the investigators seek to determine which of the two methods of study treatment results in a better subsequent quality of life for patients with 5-20 brain metastases.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible
- •Five-twenty intracranial lesions must be present on MRI of the brain
- •Age 18-80 years at diagnosis of brain metastases
- •Karnofsky performance status of at least 70
排除标准
- •Participants who have undergone prior radiation for brain metastases.
- •Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study
- •Participants who cannot undergo a brain MRI
- •Participants who cannot receive gadolinium (MRI contrast)
- •Participants with stage IV-V chronic kidney disease or end stage renal disease
- •Participants with widespread, definitive leptomeningeal disease
- •Participants with small cell lung cancer, lymphoma, or myeloma
- •Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
结局指标
主要结局
Quality of Life Survey (symptoms and interference)
时间窗: 6 months
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
次要结局
- Incidence and time to additional radiotherapeutic treatments(Through study completion, an average of 1 year)
- Incidence and time to the development of seizures(Through study completion, an average of 1 year)
- Overall survival(Through study completion, an average of 1 year)
- Neurologic survival(Through study completion, an average of 1 year)
- Incidence and time to development of radiation necrosis(Through study completion, an average of 1 year)
- Incidence and time to local recurrence of treated brain tumor(s)(Through study completion, an average of 1 year)
- Incidence and time to detection of new brain metastases(Through study completion, an average of 1 year)
- Incidence and time to development of leptomeningeal disease(Through study completion, an average of 1 year)
- Incidence and time to salvage craniotomy(Through study completion, an average of 1 year)
- Incidence and time to neurocognitive decline(1 year)
- Performance status(Through study completion, an average of 1 year)
研究者
Ayal Aizer, MD
Principal Investigator
Dana-Farber Cancer Institute