METHODS: This randomized phase III clinical trial compares pre-operative with post-operative SRS for brain metastases. A dynamic random allocation procedure will allocate an equal number of patients to each arm: pre-operative SRS followed by surgery or surgery followed by post-operative SRS.
OBJECTIVE: If pre-operative SRS improves outcomes relative to post-operative SRS, this will establish pre-operative SRS as superior. If post-operative SRS proves superior to pre-operative SRS, it will remain a standard of care and halt the increasing utilization of pre-operative SRS. If there is no difference in pre- versus post-operative SRS, then pre-operative SRS may still be preferred, given patient convenience and the potential for a condensed timeline.
CONCLUSIONS: Emerging retrospective and prospective data have demonstrated some benefits of pre-op SRS vs. post-op SRS. This study will show whether there is an increase in the time to the composite endpoint. Additionally, the study will compare overall survival; patient-reported outcomes; morbidity; completion of planned therapies; time to systemic therapy; time to regional progression; time to CNS progression; time to subsequent treatment; rate of radiation necrosis; rate of local recurrence; and rate of leptomeningeal disease.
BACKGROUND: NCT03750227 (Registration date: 21/11/2018).
方法:这项随机III期临床试验比较了术前和术后SRS治疗脑转移瘤的疗效。动态随机分配程序将为每个臂分配相等数量的患者:术前SRS,然后进行手术或手术后SRS。
目的:如果术前SRS相对于术后SRS改善了结局,这将建立术前SRS为优越。如果手术后SRS优于手术前SRS,它将仍然是一种标准的护理,并阻止术前SRS的使用增加。如果手术前后SRS没有差异,那么术前SRS可能仍然是首选,考虑到患者的便利性和精简时间表的可能性。
结论:新兴的回顾性和前瞻性数据表明,术前SRS与术后SRS。这项研究将显示到复合终点的时间是否增加。此外,本研究将比较总生存期;患者报告的结局;发病率;完成计划治疗的时间;至全身治疗的时间;至区域进展的时间;至中枢神经系统进展的时间;至后续治疗的时间;放射性坏死率;局部复发率;和软脑膜疾病的发生率.
背景:NCT03750227(注册日期:21/11/2018)。