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皮肤癌和高热和放射治疗 - SAHARA:多中心,双臂,开放标签,随机控制的II期非劣势性试验的研究方案

Winfried Arnold^1,2, Maximilian Sturz³, Nidar Batifi⁴

¹Department of Radiation Oncology, Cantonal Hospital Lucerne, Luzern, Switzerland. winfried.arnold@luks.ch.

|December 22, 2025

概括

这项研究调查了与水过红外A (wIRA) 过热的降级放射治疗 (RT) 是否可以与非黑色素瘤皮肤癌 (NMSC) 治疗的标准RT相匹配. 目标是减少老年患者的副作用和治疗时间.

科学领域:

在瘤学瘤学.
皮肤病学皮肤病学
辐射瘤学辐射瘤学

背景情况:

非黑色素瘤皮肤癌 (NMSC) 的发病率正在上升,特别是在老年白人中.
标准治疗包括手术和放射治疗 (RT),RT往往更喜欢老年患者的伴随性疾病.
过分分的RT可能会引起副作用;水过的红外A (wIRA) 过热可能会增加辐射敏感性,可能会减少RT剂量和副作用.

研究的目的:

为了比较标准RT和减级RT与NMSC的wiRA-hyperthermia相结合的局部控制结果.
为了确定新方法是否实现了标准RT的非劣等性,并具有-10%的利率.
评估二次终点,包括毒性和生活质量 (QoL).

主要方法:

一个前性,随机控制的第二阶段非劣势性试验,招募了100名65岁或以上的侵袭性NMSC (阶段≥T2) 的患者.
干预组:wiRA-高温 + RT (5 Gy 的 6 分). 控制组:标准RT (12个4Gy的分数).
主要终点:在两年内进行本地控制. 二级终点:急性/晚期毒性和高质量 (QLQ-ELD14)

主要成果:

本部分应在研究结果可用后填写.

结论:

这项试验将确定与wiRA-hyperthermia降级RT是否为NMSC提供与标准RT相比较的局部控制.
这项研究旨在建立一种潜在的更少毒性和更短的治疗方案.
成功的结局可能会改善NMSC治疗方案的老年患者,提高QoL.

关键词:

临床试验临床试验是指临床试验的临床试验.年长的患者患者.轻度高温症是一种轻度的高温症.非黑色素瘤的皮肤癌放射疗法是一种放射治疗.过水的红外A过热 (wIRA) 过热

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