Department of Neurosurgery, Erasmus Medical Center, Rotterdam, Netherlands
Department of Neurosurgery, University of California San Francisco, San Francisco, California, USA.
BMJ Open. 2024 Sep 10;14(9):e081689. doi: 10.1136/bmjopen-2023-081689.
There are no guidelines or prospective studies defining the optimal surgical treatment for glioblastomas in older patients (≥70 years), for those with a limited functioning performance at presentation (Karnofsky Performance Scale ≤70) or for those with tumours in certain locations (midline, multifocal). Therefore, the decision between resection and biopsy is varied, among neurosurgeons internationally and at times even within an institution. This study aims to compare the effects of maximal tumour resection versus tissue biopsy on survival, functional, neurological and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximise the potential to undergo adjuvant treatment.
This study is an international, multicentre, prospective, two-arm cohort study of an observational nature. Consecutive patients with glioblastoma will be treated with resection or biopsy and matched with a 1:1 ratio. Primary endpoints are (1) overall survival and (2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are (1) proportion of patients with National Institute of Health Stroke Scale deterioration at 6 weeks, 3 months and 6 months after surgery; (2) progression-free survival (PFS); (3) quality of life at 6 weeks, 3 months and 6 months after surgery and (4) frequency and severity of serious adverse events. The total duration of the study is 5 years. Patient inclusion is 4 years; follow-up is 1 year.
The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.
NCT06146725.
目前尚无指南或前瞻性研究确定老年患者（≥70 岁）、表现出有限功能状态（卡氏功能状态评分≤70）或肿瘤位于特定位置（中线、多灶性）的胶质母细胞瘤患者的最佳手术治疗方法。因此，国际上和有时甚至在一个机构内，神经外科医生对切除与活检的选择存在差异。本研究旨在比较最大限度肿瘤切除与组织活检对这些患者亚组的生存、功能、神经和生活质量结果的影响。此外，还评估了哪种方式可以最大限度地提高接受辅助治疗的潜力。
这是一项国际性、多中心、前瞻性、观察性的双臂队列研究。连续的胶质母细胞瘤患者将接受切除或活检治疗，并以 1:1 的比例匹配。主要终点是（1）总生存和（2）接受化疗和放疗辅助治疗的患者比例。次要终点是（1）术后 6 周、3 个月和 6 个月时 National Institute of Health Stroke Scale 恶化的患者比例；（2）无进展生存期（PFS）；（3）术后 6 周、3 个月和 6 个月的生活质量；（4）严重不良事件的频率和严重程度。研究总持续时间为 5 年。患者纳入时间为 4 年；随访时间为 1 年。
该研究已获得医学伦理委员会（南荷兰/伊拉斯谟医学中心医学伦理委员会；MEC-2020-0812）的批准。研究结果将发表在同行评议的学术期刊上，并分发给患者组织和媒体。
NCT06146725。
