PDF(Pubmed)
Abstract：
OBJECTIVE: Almost one third of cancer patients in the United States will develop brain metastases on an annual basis. Surgical resection is indicated in the setting of brain metastases for reasons, such as maximizing local control in select patients, decompression of mass effect, and/or tissue diagnosis. The current standard of care following resection of a brain metastasis has shifted from whole brain radiation therapy to post-operative stereotactic radiosurgery (SRS). However, there is a significant rate of local recurrence within one year of postoperative SRS. Emerging retrospective and prospective data suggest pre-operative SRS is a safe and potentially effective treatment paradigm for surgical brain metastases. This trial intends to determine, for patients with an indication for resection of a brain metastasis, whether there is an increase in the time to a composite endpoint of adverse outcomes; including the first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis - in patients who receive pre-operative SRS as compared to patients who receive post-operative SRS.
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).
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).
摘要：
目的：美国近三分之一的癌症患者每年都会发生脑转移。在脑转移的背景下，手术切除是有原因的，例如最大限度地控制选定的患者，质量效应的减压，和/或组织诊断。脑转移切除术后的当前护理标准已从全脑放射治疗转变为术后立体定向放射外科（SRS）。然而,SRS术后1年内局部复发率显著。新出现的回顾性和前瞻性数据表明，术前SRS是外科脑转移的安全且潜在有效的治疗范例。这项审判旨在确定，对于有脑转移瘤切除指征的患者，到不良结局的复合终点的时间是否增加；包括首次出现以下情况之一：局部复发，软脑膜疾病，或有症状的放射性脑坏死-与接受术后SRS的患者相比，接受术前SRS的患者。
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）。
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）。
