A Randomized Controlled Trial of Pre-operative Versus Post-operative Stereotactic Radiosurgery for Patients With Surgically Resectable Brain Metastases
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Local Control
研究概览
简要总结
The purpose of this study is to determine if performing radiotherapy (SRS) prior to surgery results in better treatment outcomes than performing surgery before radiotherapy for patients with brain metastases.
Brain metastases occur when cancer cells from a primary cancer (e.g. lung, breast, colon) travel through the bloodstream and spread (metastasize) to the brain. As these new tumors grow they apply pressure and change how healthy brain tissue works. This can lead to a loss of brain function and worsening quality of life. Treatments for patients whose cancer has spread to the brain is often surgery, radiation therapy (radiotherapy) or a combination of both.
Surgery is one the main treatments for brain tumors. To remove the tumor, a neurosurgeon makes an opening in the skull and attempts to the remove the entire tumor. If the tumor is too close to important brain tissue, the surgeon may attempt to remove part of the tumor. Removal of the tumor from the brain tissue is called resection. The complete or partial removal of tumor helps to relieve symptoms by reducing pressure on healthy tissues and reduces the amount of tumor that needs to be treated by radiotherapy.
One type of radiotherapy used to treat brain metastases is stereotactic radiosurgery (SRS). SRS uses many focused radiation beams to treat tumors within the brain. Unlike surgery, there is no incision or cut being made. Instead, SRS uses an accurate map of your brain to deliver a precise beam of radiation to the tumors. The radiation damages the tumor cells forcing them to shrink and die off. The focused radiation beams also limit damage to healthy brain tissue minimizing side effects.
Surgery followed by radiotherapy is a standard treatment for brain metastases. However, there are still risks associated with the combination of treatments. This study plans to investigate whether performing surgery prior to SRS results in improved quality of life and decreased side effects.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Pathologically-proven primary malignancy
- •Ability to complete neurocognitive testing without assistance from family or friends.
- •Previous SRS to lesions other than the one being resected is allowed
- •Patients of childbearing / reproductive potential must have a negative urine or serum pregnancy test ≤7 days before enrollment
- •Participants capable of giving informed consent, or if appropriate participants having an acceptable individual capable of giving consent
排除标准
- •Patients who have received prior WBRT, or SRS to the lesion being resected at time of study accrual
- •Patients unable to undergo MRI scan (e.g. pacemaker)
- •Leptomeningeal disease
- •Germ cell tumor, small cell lung cancer or hematological primary malignancy
结局指标
主要结局
Local Control
时间窗: This will be assessed at 12 months
To compare local control (in months) of pre-operative versus post-operative SRS
次要结局
- Distant Brain Recurrence Rate(This will be assessed at 6,12 and 24 months.)
- Hopkins Verbal Learning Test(This will be assessed at 3,6,9,12,16 and 24 months.)
- Local Control(This will be assessed at 6 and 24 months.)
- Leptomeningeal Recurrence Rate(This will be assessed at 6,12 and 24 months.)
- Overall Survival(This will be assessed at 6,12 and 24 months.)
- Trial Making Tests(This will be assessed at 3,6,9,12,16 and 24 months.)
- Controlled Oral Word Association(This will be assessed at 3,6,9,12,16 and 24 months.)