Background: Integrating deep regional hyperthermia (HT) with neoadjuvant chemoradiotherapy (CRT) may enhance treatment efficacy in locally advanced rectal cancer (LARC), yet feasibility and tolerance data remain scarce for both short-course (SCRT) and long-course (LCRT) radiotherapy (RT) regimens. Methods: In this single-center prospective observational study, 67 LARC patients received neoadjuvant RT and chemotherapy (CT) combined with deep radiative HT using a phased-array system (ALBA 4D). Patients treated with SCRT (5 × 5 Gy) were prescribed two HT sessions; those treated with LCRT (25 × 2 Gy) were prescribed ten. HT planning was guided by dedicated software, and real-time thermometry ensured precise thermal delivery. Feasibility was defined as completion of ≥50% of prescribed sessions. Tolerance and toxicity were assessed with standardized clinical scales (QMHT, UMC, CTCAE v4.03). Results: HT was feasible in both groups: 100% of SCRT and 63.6% of LCRT patients completed ≥50% of prescribed sessions. In total, 243 sessions were delivered. Most symptoms were mild and transient, predominantly localized pain. No grade ≥3 HT-related toxicities occurred. All scheduled RT and surgery proceeded without delay. Median T50 was 40.3 °C (SCRT) and 40.4 °C (LCRT); the median RT-to-HT interval was 42 min in both groups. Conclusion: This first Spanish experience shows that deep radiative HT can be seamlessly integrated into both SCRT and LCRT neoadjuvant protocols for rectal cancer. High adherence, favorable tolerance, and reliable thermal control support clinical implementation. Any between-schedule observations are descriptive only; no formal comparative testing was performed. The study was not designed or powered to establish comparative effectiveness between SCRT and LCRT, and the sample size was insufficient to detect rare HT-specific adverse events.
背景：将深部区域热疗（HT）与新辅助放化疗（CRT）相结合可能提高局部晚期直肠癌（LARC）的治疗效果，但目前关于短程（SCRT）和长程（LCRT）放疗（RT）方案联合热疗的可行性和耐受性数据仍然匮乏。方法：在这项单中心前瞻性观察性研究中，67例LARC患者接受了新辅助放疗和化疗（CT）联合相控阵系统（ALBA 4D）的深部辐射热疗。接受SCRT（5 × 5 Gy）治疗的患者计划进行两次HT；接受LCRT（25 × 2 Gy）治疗的患者计划进行十次。HT计划由专用软件指导，实时测温确保了精准的热量输送。可行性定义为完成≥50%的计划治疗次数。耐受性和毒性采用标准化临床量表（QMHT、UMC、CTCAE v4.03）进行评估。结果：两组患者均可行HT：100%的SCRT患者和63.6%的LCRT患者完成了≥50%的计划治疗次数。总共进行了243次治疗。大多数症状轻微且短暂，主要为局部疼痛。未发生≥3级的HT相关毒性。所有计划的放疗和手术均如期进行。中位T50温度在SCRT组为40.3°C，在LCRT组为40.4°C；两组的中位放疗至热疗间隔时间均为42分钟。结论：这项西班牙首次经验表明，深部辐射热疗可以无缝整合到直肠癌的SCRT和LCRT新辅助治疗方案中。高依从性、良好的耐受性和可靠的热控制支持其临床应用。任何不同方案间的观察结果仅为描述性；未进行正式的对比检验。本研究并非旨在或具备足够效力来确立SCRT与LCRT之间的相对疗效，且样本量不足以检测罕见的HT特异性不良事件。
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