Department of Oncology, Oslo University Hospital, Oslo, Norway
Institute for Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
BMJ Open. 2023 Mar 20;13(3):e070071. doi: 10.1136/bmjopen-2022-070071.
The use of proton therapy increases globally despite a lack of randomised controlled trials demonstrating its efficacy and safety. Proton therapy enables sparing of non-neoplastic tissue from radiation. This is principally beneficial and holds promise of reduced long-term side effects. However, the sparing of seemingly non-cancerous tissue is not necessarily positive for isocitrate dehydrogenase ()-mutated diffuse gliomas grade 2-3, which have a diffuse growth pattern. With their relatively good prognosis, yet incurable nature, therapy needs to be delicately balanced to achieve a maximal survival benefit combined with an optimised quality of life.
PRO-GLIO (PROton versus photon therapy in -mutated diffuse grade 2 and 3 GLIOmas) is an open-label, multicentre, randomised phase III non-inferiority study. 224 patients aged 18-65 years with -mutated diffuse gliomas grade 2-3 from Norway and Sweden will be randomised 1:1 to radiotherapy delivered with protons (experimental arm) or photons (standard arm). First intervention-free survival at 2 years is the primary endpoint. Key secondary endpoints are fatigue and cognitive impairment, both at 2 years. Additional secondary outcomes include several survival measures, health-related quality of life parameters and health economy endpoints.
To implement proton therapy as part of standard of care for patients with -mutated diffuse gliomas grade 2-3, it should be deemed safe. With its randomised controlled design testing proton versus photon therapy, PRO-GLIO will provide important information for this patient population concerning safety, cognition, fatigue and other quality of life parameters. As proton therapy is considerably more costly than its photon counterpart, cost-effectiveness will also be evaluated. PRO-GLIO is approved by ethical committees in Norway (Regional Committee for Medical & Health Research Ethics) and Sweden (The Swedish Ethical Review Authority) and patient inclusion has commenced. Trial results will be published in international peer-reviewed journals, relevant conferences, national and international meetings and expert forums.
ClinicalTrials.gov Registry (NCT05190172).
尽管缺乏随机对照试验证明质子治疗的疗效和安全性，但质子治疗的使用在全球范围内仍不断增加。质子治疗能够使非肿瘤组织免受辐射。这主要是有益的，并有望减少长期的副作用。然而，对于具有弥漫性生长模式的 IDH 突变弥漫性 2-3 级胶质瘤来说，看似非癌性组织的保护并不一定是积极的。由于其相对较好的预后，但仍无法治愈，治疗需要谨慎平衡，以实现最大的生存获益，并结合优化的生活质量。
PRO-GLIO（质子与光子治疗 IDH 突变弥漫性 2 和 3 级胶质瘤）是一项开放标签、多中心、随机 III 期非劣效性研究。来自挪威和瑞典的 224 名年龄在 18-65 岁之间的 IDH 突变弥漫性 2-3 级胶质瘤患者将按 1:1 随机分为质子（实验组）或光子（标准组）放疗。主要终点是 2 年时的无进展生存。关键次要终点是 2 年时的疲劳和认知障碍。其他次要结局包括多种生存指标、健康相关生活质量参数和健康经济学终点。
为了将质子治疗作为 IDH 突变弥漫性 2-3 级胶质瘤患者标准治疗的一部分，它应该被认为是安全的。PRO-GLIO 采用随机对照设计，比较质子与光子治疗，将为这一患者群体提供关于安全性、认知、疲劳和其他生活质量参数的重要信息。由于质子治疗比光子治疗昂贵得多，因此也将评估其成本效益。PRO-GLIO 已获得挪威（地区医学和健康研究伦理委员会）和瑞典（瑞典伦理审查局）的伦理委员会批准，并已开始入组患者。试验结果将在国际同行评议期刊、相关会议、国家和国际会议以及专家论坛上发表。
ClinicalTrials.gov 注册号（NCT05190172）。
