质子与光子辐射疗法对初级脑瘤的成年人评估功能生存:一个第三阶段随机对照试验研究协议 (PRIDE)
Archya Dasgupta1,2, Suman Ghosh3,4, Abhishek Chatterjee3,4
1Department of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, HBNI, Mumbai, 410210, India. archya1010@gmail.com.
Radiation oncology (London, England)
|February 14, 2026
概括
与强度调节辐射疗法 (IMRT) 相比,质子束疗法 (PBT) 可能会改善原发性脑瘤的成年人的功能生存率. 本试验调查了PBT在减少长期副作用的作用,以改善患者的治疗结果.
科学领域:
- 神经瘤学神经瘤学
- 辐射瘤学 辐射瘤学
- 临床试验 临床试验
背景情况:
- 放射治疗 (RT) 对原发性脑瘤至关重要,但会导致长期的功能性疾病.
- 基于光子的RT,包括强度调节辐射疗法 (IMRT),导致诸如认知衰退和内分泌功能障碍等副作用.
- 质子束疗法 (PBT) 提供了更好的功能维护的潜力,但成人数据有限.
研究的目的:
- 提供1级证据,证明PBT在原发性脑瘤成年人的功能结果中的作用.
- 为了比较PBT与IMRT在维护功能和改善生存的疗效.
- 建立PBT作为神经瘤学潜在的护理标准.
主要方法:
- 一个前性的,开放的,第三期随机对照试验 (PRIDE研究) 招募了156名患有原发性脑瘤的成年人 (18-70岁).
- 随机化 (1:1) 给光子-IMRT或PBT,分层按年龄,瘤类型,近距离下丘脑-垂体轴和辐射剂量.
- 主要终点:5年功能生存期 (生存期没有神经认知衰退,耳毒性,内分泌功能障碍等). 二级终点:生活质量和健康经济学.
主要成果:
- 该研究旨在检测5年功能生存率的25%绝对改善,有利于PBT (65%对40%).
- 在50%的事件 (n=28) 之后,计划进行临时分析.
- 统计分析包括卡普兰-梅尔方法,日志级别测试,线性混合效应和非参数测试.
结论:
- 这项试验将提供1级证据,证明PBT对成人原发性脑瘤患者的功能结果的影响.
- 如果达到主终点,PBT可能会成为标准的护理,影响未来的神经瘤学实践.
- 这些发现将指导当代神经瘤学实践,涉及先进的辐射技术.
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