Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Time to local recurrence
研究概览
简要总结
This randomized phase III trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. Stereotactic radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate benefit of post-surgical stereotactic radiosurgery (SRS) on the resection bed in providing 6 month local control (decreasing the risk of local tumor recurrence) when compared to surgical resection alone.
SECONDARY OBJECTIVES:
I. Overall survival, development of distant brain metastases and complications related to treatment.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3).
- •Patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a complete resection of at least one lesion as determined the study neuroradiologist.
- •The resection cavity must have a maximum diameter of less than or equal to 4cm. This criteria will be determined by the study radiologist.
- •Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm.
- •Patients must be considered candidates for SRS within 30 days of surgical resection.
- •Patients must have a Karnofsky Performance Scores (KPS) of at least 70 at the first post operative visit. Patients under 18 years of age must have a Lansky Performance Score of of at least
- •Patients must be able to undergo an MRI scan.
- •Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form.
排除标准
- •Patients who have received prior radiation therapy to the brain for any reason.
- •There is radiographic evidence of leptomeningeal disease prior to study entry.
- •The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
- •For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy).
研究组 & 干预措施
Arm I (SRS)
Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy.
干预措施: Stereotactic Radiosurgery (Radiation)
Arm II (observation)
Patients undergo clinical observation after craniotomy.
结局指标
主要结局
Time to local recurrence
时间窗: 6 months
A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates. The proportion of patients experiencing neurological complications will be computed via univariate and multivariate logistic regression analysis.
次要结局
- Overall survival(Up to 8 years)
- Incidence of complications related to treatment(Up to 8 years)
- Proportion of complications resulting in prolongation of hospital stay(Up to 8 years)
- Time to first neurological complication(Up to 8 years)
- Development of distant brain metastases(Up to 8 years)
- Proportion of patients experiencing neurological complications(Up to 8 years)