Zhong Liangzhi, Zhou Pu, Chen Lu, Chen Diangang, Wen Li, Diao Xinwei, Zhang Anmei, Gao Yixing, Chen Guangpeng, Li Xueqin, Huang Shaojiang, Niu Kai, Pei Yuchun, Liu Guolong, Lv Shengqing, Li Guanghui
Cancer Research Institute of the Chinese People's Liberation Army, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China.
Department of Oncology, Shapingba Hospital affiliated to Chongqing University, Chongqing University, Chongqing, People's Republic of China.
JAMA Netw Open. 2025 Jul 1;8(7):e2523053. doi: 10.1001/jamanetworkopen.2025.23053.
Optimizing irradiation volumes and evaluating the effect of dose escalation on total and fractionated doses are critical for improving outcomes in high-grade glioma (HGG).
To assess the efficacy of modified target delineation guided by multimodal magnetic resonance imaging and white matter tracts combined with moderately hypofractionated simultaneous boost intensity-modulated radiotherapy (HSIB-IMRT) in patients with newly diagnosed HGG.
DESIGN, SETTING, AND PARTICIPANTS: This single-center, 2-arm, open-label randomized clinical trial enrolled 154 patients aged 18 to 70 years with histologically confirmed, newly diagnosed HGG at a Chinese medical center from January 1, 2018, to August 31, 2022. Follow-up was completed in June 2024.
Patients were randomized to receive modified target delineation guided by multimodal magnetic resonance imaging and white matter tracts combined with HSIB-IMRT (experimental arm) or standard IMRT per guideline recommendations (standard arm). Both arms received concurrent and adjuvant temozolomide chemotherapy.
The primary end point was progression-free survival (PFS). The secondary end point was overall survival (OS).
Among 154 enrolled patients (76 in the experimental arm and 78 in the standard arm; 85 [55.2%] male; median [range] age, 51.5 [23.0-70.0] years), the median (range) follow-up duration was 22 (4-76) months, with 96 deaths by June 2024. The median PFS was 15.5 months (95% CI, 11.7-19.3 months) in the experimental arm and 13.5 months (95% CI, 8.7-18.3 months) in the standard arm (P = .89). The median OS was 27.0 months (95% CI, 13.9-40.1 months) in the experimental arm and 21.0 months (95% CI, 18.0-24.0 months) in the standard arm (P = .24). The clinical target volume in the experimental arm (CTV1: median [range], 116.7 [20.2-370.7 cm3]; CTV2: median [range], 174.4 [34.5-463.2 cm3]) was significantly smaller than the clinical target volume in the standard arm (median [range], 225.0 [70.2-542.1 cm3]; P < .001). Recurrence rates within, outside, and multicentric to the target volume were comparable between arms. Grade 3 or 4 adverse events occurred in 4 patients (5.3%) in the experimental arm and 3 (3.8%) in the standard arm (P = .72).
In this randomized clinical trial, modified target delineation with HSIB-IMRT demonstrated comparable PFS and OS to standard IMRT in patients with newly diagnosed HGG, while significantly reducing the irradiation target volume without increasing the recurrence rates outside the target volume. These results suggest valuable insights for future research aimed at personalized, reduced volume strategies to optimize outcomes and minimize neurotoxicity in HGG.
ChiCTR.org.cn Identifier: ChiCTR1800014396.
优化照射体积并评估剂量递增对总剂量和分次剂量的影响对于改善高级别胶质瘤（HGG）的治疗效果至关重要。
评估在多模态磁共振成像和白质束引导下进行改良靶区勾画联合适度低分割同步推量调强放疗（HSIB-IMRT）对新诊断HGG患者的疗效。
设计、地点和参与者：这项单中心、双臂、开放标签随机临床试验于2018年1月1日至2022年8月31日在中国一家医疗中心招募了154例年龄在18至70岁之间、经组织学确诊为新诊断HGG的患者。随访于2024年6月完成。
患者被随机分配接受多模态磁共振成像和白质束引导下的改良靶区勾画联合HSIB-IMRT（试验组）或按照指南推荐接受标准IMRT（标准组）。两组均接受同步和辅助替莫唑胺化疗。
主要终点是无进展生存期（PFS）。次要终点是总生存期（OS）。
在154例入组患者中（试验组76例，标准组78例；男性85例[55.2%]；中位[范围]年龄，51.5[23.0 - 70.0]岁），中位（范围）随访时间为22（4 - 76）个月，到2024年6月有96例死亡。试验组的中位PFS为15.5个月（95%CI，11.7 - 19.3个月），标准组为13.5个月（95%CI，8.7 - 18.3个月）（P = 0.89）。试验组的中位OS为27.0个月（95%CI，13.9 - 40.1个月），标准组为21.0个月（95%CI，18.0 - 24.0个月）（P = 0.24）。试验组的临床靶区体积（CTV1：中位[范围]，116.7[20.2 - 370.7 cm³]；CTV2：中位[范围]，174.4[34.5 - 463.2 cm³]）显著小于标准组的临床靶区体积（中位[范围]，225.0[70.2 - 542.1 cm³]；P < 0.001）。两组在靶区内、外及多中心的复发率相当。试验组有4例患者（5.3%）发生3级或4级不良事件，标准组有3例（3.8%）（P = 0.72）。
在这项随机临床试验中，对于新诊断的HGG患者，HSIB-IMRT联合改良靶区勾画显示出与标准IMRT相当的PFS和OS，同时显著减小了照射靶区体积且未增加靶区外的复发率。这些结果为未来旨在采用个性化、缩小体积策略以优化HGG治疗效果并最小化神经毒性的研究提供了有价值的见解。
中国临床试验注册中心标识符：ChiCTR1800014396。
