目的:评估神经认知能力,日常活动和生活质量(QoL),除了通常的肿瘤结果,在接受立体定向脑照射(SBI)或全脑照射(WBI)治疗的实体肿瘤脑转移≥5(MBM)的患者中。
方法:这项多中心随机对照试验将纳入100名MBM≥5,年龄≥18岁的患者(每组50名),Karnofsky绩效状态(KPS)≥70,预期寿命>3个月,已知的原发性肿瘤,患有受控或可控的颅外疾病,基线蒙特利尔认知评估(MoCA)评分≥20/30,Barthel日常生活活动评分≥90/100,由LINAC采用单等中心技术和非共面弧(实验臂)或WBI(控制臂)提交给SBI。主要终点是神经认知表现,日常生活活动变化中的QoL和自主性,第一个由MoCa评分和霍普金斯言语学习测试评估-修订,第二个通过EORTCQLQ-C15-PAL和QLQ-BN-20问卷,通过Barthel指数的第三个,分别。次要终点是颅内衰竭的时间,总生存率,再治疗率,急性和晚期毒性,改变KPS。两个臂之间的至少30%的统计差异将被认为是显著的(80%的统计能力和95%的显著性水平)。
结论:一些研究争论的是,在接受MBM脑照射的患者中,神经认知衰退的发展的决定性因素是什么:辐射对临床健康的脑组织或颅内肿瘤负担的影响?这个问题的答案可能来自最近的技术进步,在节省大量时间的情况下,改善患者的舒适度,最大限度地减少对脱靶大脑的辐射剂量,同时选择性治疗MBM,否则只能通过WBI攻击。实现与使用WBI获得的控制率相当的本地控制率仍然是基本前提。
背景:NCT编号:NCT04891471。
OBJECTIVE: To evaluate neurocognitive performance, daily activity and quality of life (QoL), other than usual oncologic outcomes, among patients with brain metastasis ≥5 (MBM) from solid tumors treated with Stereotactic Brain Irradiation (SBI) or Whole Brain Irradiation (WBI).
METHODS: This multicentric randomized controlled trial will involve the enrollment of 100 patients (50 for each arm) with MBM ≥ 5, age ≥ 18 years, Karnofsky Performance Status (KPS) ≥ 70, life expectancy > 3 months, known primary tumor, with controlled or controllable extracranial disease, baseline Montreal Cognitive Assessment (MoCA) score ≥ 20/30, Barthel Activities of Daily Living score ≥ 90/100, to be submitted to SBI by LINAC with monoisocentric technique and non-coplanar arcs (experimental arm) or to WBI (control arm). The primary endpoints are neurocognitive performance, QoL and autonomy in daily-life activities variations, the first one assessed by MoCa Score and Hopkins Verbal Learning Test-Revised, the second one through the EORTC QLQ-C15-PAL and QLQ-BN-20 questionnaires, the third one through the Barthel Index, respectively. The secondary endpoints are time to intracranial failure, overall survival, retreatment rate, acute and late toxicities, changing of KPS. It will be considered significant a statistical difference of at least 30% between the two arms (statistical power of 80% with a significance level of 95%).
CONCLUSIONS: Several studies debate what is the decisive factor accountable for the development of neurocognitive decay among patients undergoing brain irradiation for MBM: radiation effect on clinically healthy brain tissue or intracranial tumor burden? The answer to this question may come from the recent technological advancement that allows, in a context of a significant time saving, improved patient comfort and minimizing radiation dose to off-target brain, a selective treatment of MBM simultaneously, otherwise attackable only by WBI. The achievement of a local control rate comparable to that obtained with WBI remains the fundamental prerequisite.
BACKGROUND: NCT number: NCT04891471.