Background/Objectives:The historically most commonly used preoperative radiotherapy regimen for soft tissue sarcomas (STSs) consists of 50 Gray (Gy) delivered in 25 fractions over 5 weeks, achieving excellent local control, but with significant challenges due to prolonged treatment duration and early side effects. Reducing therapy duration while maintaining optimal local and distant control would be highly beneficial for patients. We aimed to investigate the outcome of an ultrahypofractionated radiotherapy (uhRT) regimen which may represent a shorter and more patient-friendly alternative.Methods:This multi-center, open-label, phase 2 clinical trial with a clustered cohort design was conducted within the Swiss Sarcoma Network (SSN). Adult patients (aged ≥ 18 years) with STS of the extremities or superficial trunk and an Eastern Cooperative Oncology Group (ECOG) performance status of 0–3 were included. Participants were assigned to either normofractionated radiotherapy (nRT) at 50 Gy in 25 fractions or uhRT at 25 Gy in 5 fractions. Data were collected prospectively in real-world-time clinical settings. The primary outcome was local recurrence-free survival (LRFS), with overall survival (OS) and wound complications as secondary outcomes.Results:Between March 2020 and October 2023, 138 patients were included in the study; 74 received nRT and 64 received uhRT. The median follow-up times were 2.2 years for uhRT and 3.6 years for nRT. The LRFS rates at 1 year were 97.0% for nRT and 94.8% for uhRT (p= 0.57). The two-year LRFS rates were 91.9% and 94.8%, respectively (p= 0.57). The one- and two-year OS rates were 97.1%/86.3% and 98.2%/88.8%, respectively (p= 0.72). The wound complication rate was comparable between the nRT (12.0%) and uhRT (12.5%) groups (p= 0.99).Conclusions:UhRT for STSs offers an effective and safe alternative to traditional nRT, with comparable early LRFS, OS and wound complication rates. Given the two-year median follow-up, which is critical for evaluating local recurrence, uhRT shows promise as a shorter and more convenient treatment regimen. UhRT may be a safe and effective alternative treatment option to traditional nRT.
背景/目的：软组织肉瘤（STSs）历史上最常用的术前放疗方案为5周内分25次照射50戈瑞（Gy），该方案局部控制效果优异，但因治疗周期长及早期副作用显著而面临挑战。缩短治疗时间同时维持理想的局部与远处控制对患者具有重要临床意义。本研究旨在探讨超大分割放疗（uhRT）方案的效果，该方案可能成为更短程且更利于患者的替代选择。 方法：本项采用聚类队列设计的多中心、开放标签、II期临床试验在瑞士肉瘤网络（SSN）内开展。研究纳入年龄≥18岁、四肢或躯干浅表部位STS且美国东部肿瘤协作组（ECOG）体能状态评分为0-3分的成年患者。参与者被分配接受常规分割放疗（nRT，50 Gy/25次）或超分割放疗（uhRT，25 Gy/5次）。数据在真实临床环境中前瞻性实时收集。主要结局指标为局部无复发生存期（LRFS），次要结局指标包括总生存期（OS）及伤口并发症。 结果：2020年3月至2023年10月期间，共138例患者入组研究，其中74例接受nRT，64例接受uhRT。uhRT组中位随访时间为2.2年，nRT组为3.6年。1年LRFS率nRT组为97.0%，uhRT组为94.8%（p=0.57）；2年LRFS率分别为91.9%和94.8%（p=0.57）。1年及2年OS率分别为97.1%/86.3%和98.2%/88.8%（p=0.72）。伤口并发症发生率在nRT组（12.0%）与uhRT组（12.5%）间无显著差异（p=0.99）。 结论：对于STS患者，uhRT可作为传统nRT的有效且安全的替代方案，其早期LRFS、OS及伤口并发症发生率均与传统方案相当。鉴于评估局部复发的关键指标——中位随访时间已达两年，uhRT展现出作为更短程、更便捷治疗方案的潜力，可能成为传统nRT安全有效的替代治疗选择。
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