旨在确定与非小细胞肺癌 (NSCLC) 标准放疗相比，基于 4DCT 通气的功能性肺回避放疗是否可以保留肺功能。这项单中心、随机、2 期试验纳入了接受治疗的 NSCLC 患者2016 年至 2022 年间，采用立体定向全身放疗或传统分割放疗进行治愈性意向放疗。患者按 1:1 的比例随机接受标准护理放疗或功能性肺回避放疗。主要终点是 4DCT 测量的基于雅可比的通气量从基线到辐射后三个月的变化。次要终点包括高通气和低通气肺容量的变化、肺毒性以及肺功能测试 (PFT) 的变化。共有 122 名患者被随机分组​​，其中 116 名可用于分析。中位随访时间为 29.9 个月。功能性回避计划显着 (P<.05) 减少了高功能肺的剂量，而不影响目标覆盖或处于风险限制的器官。在分析所有患者时，从基线到 3 个月，两组之间显示通气量减少的肺量没有差异（1.91% vs 1.87%；P=.90）。所有患者的总体≥2级和≥3级肺部毒性分别为24.1%和8.6%。两个研究组之间的肺毒性或 PFT 变化没有显着差异。在传统分割队列中，≥2 级肺炎发生率较低（8.2% vs 32.3%；P=.049），FEV1 变化下降幅度较小（-3 vs -5；P=.042） 3 个月时的 FVC（1.5 vs -6；P=.005），有利于功能性回避组。通过 4DCT 测量，治疗后通气量在各组之间没有差异。在接受功能性肺回避的传统分割放疗的患者队列中，肺毒性降低，PFT 下降幅度较小，这表明对局部晚期 NSCLC 患者具有临床益处。ClinicalTrials.gov 标识符：NCTXXXX 匿名审查 XXXX.Copyright © 2024 年。由爱思唯尔公司出版。

To determine whether 4-dimensional computed tomography (4DCT) ventilation-based functional lung avoidance radiotherapy preserves pulmonary function compared with standard radiotherapy for non-small cell lung cancer (NSCLC).This single center, randomized, phase 2 trial enrolled patients with NSCLC receiving curative intent radiotherapy with either stereotactic body radiotherapy or conventionally fractionated radiotherapy between 2016 and 2022. Patients were randomized 1:1 to standard of care radiotherapy or functional lung avoidance radiotherapy. The primary endpoint was the change in Jacobian-based ventilation as measured on 4DCT from baseline to three months post-radiation. Secondary endpoints included changes in volume of high- and low-ventilating lung, pulmonary toxicity, and changes in pulmonary function tests (PFTs).A total of 122 patients were randomized and 116 were available for analysis. Median follow up was 29.9 months. Functional avoidance plans significantly (P<.05) reduced dose to high-functioning lung without compromising target coverage or organs at risk constraints. When analyzing all patients, there was no difference in the amount of lung showing a reduction in ventilation from baseline to 3 months between the two arms (1.91% vs 1.87%; P=.90). Overall grade ≥2 and grade ≥3 pulmonary toxicities for all patients were 24.1% and 8.6%, respectively. There was no significant difference in pulmonary toxicity or changes in PFTs between the two study arms. In the conventionally fractionated cohort, there was a lower rate of grade ≥2 pneumonitis (8.2% vs 32.3%; P=.049) and less of a decline in change in FEV1 (-3 vs -5; P=.042) and FVC (1.5 vs -6; P=.005) at 3 months, favoring the functional avoidance arm.There was no difference in post-treatment ventilation as measured by 4DCT between the arms. In the cohort of patients treated with conventionally fractionated radiotherapy with functional lung avoidance, there was reduced pulmonary toxicity, and less decline in PFTs suggesting a clinical benefit in patients with locally advanced NSCLC.ClinicalTrials.gov Identifier: NCTXXXX Anonymized for Review XXXX.Copyright © 2024. Published by Elsevier Inc.