Department of Radiation Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Department of Neurological Surgery, Mayo Clinic, Rochester, MN, USA.
BMC Cancer. 2024 Mar 12;24(1):332. doi: 10.1186/s12885-024-12060-9.
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.
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.
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.
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.
NCT03750227 (Registration date: 21/11/2018).
美国每年约有三分之一的癌症患者会发生脑转移。出于某些原因，如在某些患者中最大限度地控制局部肿瘤、减轻肿块占位效应和/或进行组织诊断，手术切除脑转移瘤是合理的选择。脑转移瘤切除术后的标准治疗方法已经从全脑放疗转变为术后立体定向放疗（SRS）。然而，术后 SRS 后一年内局部复发率仍然较高。新出现的回顾性和前瞻性数据表明，术前 SRS 是一种安全且可能有效的手术脑转移瘤治疗方案。本试验旨在确定对于有脑转移瘤切除适应证的患者，与术后 SRS 相比，术前 SRS 是否会增加不良结局的复合终点时间；包括首次出现以下任何一种情况：局部复发、脑膜疾病或症状性放射性脑坏死——接受术前 SRS 的患者与接受术后 SRS 的患者相比。
这是一项随机的 III 期临床试验，比较了脑转移瘤患者的术前和术后 SRS。动态随机分配程序将为每个手臂分配相同数量的患者：术前 SRS 后行手术或手术后继发术后 SRS。
如果术前 SRS 改善了与术后 SRS 的结局，那么这将确立术前 SRS 的优越性。如果术后 SRS 优于术前 SRS，那么它将仍然是一种标准的治疗方法，并阻止术前 SRS 的应用日益增加。如果术前 SRS 和术后 SRS 之间没有差异，那么鉴于患者的便利性和潜在的治疗时间缩短，术前 SRS 可能仍然更受欢迎。
新出现的回顾性和前瞻性数据表明术前 SRS 与术后 SRS 相比具有一定的优势。本研究将显示在复合终点时间上是否有增加。此外，该研究将比较总生存时间；患者报告的结果；发病率；计划治疗的完成情况；系统治疗时间；区域进展时间；中枢神经系统进展时间；后续治疗时间；放射性坏死率；局部复发率；脑膜疾病发生率。
NCT03750227（注册日期：2018 年 11 月 21 日）。
