Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.
BMJ Open. 2024 Mar 8;14(3):e078926. doi: 10.1136/bmjopen-2023-078926.
Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.
BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent's three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.
BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.
ISRCTN60524.
胶质母细胞瘤（GBM）是最常见的成人原发性恶性脑肿瘤。这种疾病无法治愈，尽管在初次就诊时进行了积极的治疗，但几乎所有肿瘤在中位 7 个月后都会复发。复发时的治疗目的是延长生存期并保持健康相关生活质量（HRQoL）。化疗通常用于复发性 GBM，通常使用含亚硝基脲的方案。然而，疗效有限，复发后的中位生存期报告在 5 至 9 个月之间。虽然在英国不太常用，但越来越多的证据表明再放疗可能产生至少与含亚硝基脲的化疗相似的生存结果。然而，对于最佳方法仍存在不确定性，并且可用数据很少，尤其是在 HRQoL 方面。脑再放疗或化疗（BRIOChe）旨在评估再放疗作为 IDH 野生型 GBM 复发的可接受治疗选择。
BRIOChe 是一项多中心、开放标签、随机 II 期临床试验，纳入复发性 GBM 患者。该试验使用 Sargent 的三结局设计，将从 10 至 15 个英国放疗中心招募约 55 名患者，按 2:1 比例分配接受再放疗（35Gy，每日 10 次分割）或含亚硝基脲的化疗（最多 6 个，每 6 周一次）。主要终点是再放疗患者的 9 个月总生存率。对于决策性主要分析，将不会对治疗组进行正式的统计学比较。化疗组将用于校准目的，以收集辅助解释结果的同期数据。次要结局包括 HRQoL、地塞米松需求、抗癫痫药需求、影像学反应、治疗依从性、急性和迟发性毒性、无进展生存期。
BRIOChe 从北爱尔兰研究伦理委员会办公室获得了伦理批准（编号为 20/NI/0070）。最终试验结果将发表在同行评议的期刊上，并遵循 ICMJE 指南。
ISRCTN60524。
