(1) Background: Our purpose is to describe the design of a phase II clinical trial on 5-fraction proton therapy for chordomas and chondrosarcomas of the skull base and to present early results in terms of local control and clinical tolerance of the first prospective series. (2) Methods: A dose of 37.5 GyRBE in five fractions was proposed for chordomas and 35 GyRBE in five fractions for chondrosarcomas. The established inclusion criteria are age ≥ 18 years, Karnofsky Performance Status ≥ 70%, clinical target volume up to 50 cc, and compliance with dose restrictions to the critical organs. Pencil beam scanning was used for treatment planning, employing four to six beams. (3) Results: A total of 11 patients (6 chordomas and 5 chondrosarcomas) were included. The median follow-up was 12 months (9–15 months) with 100% local control. Acute grade I–II headache (64%), grade I asthenia and alopecia (45%), grade I nausea (27%), and grade I dysphagia (18%) were described. Late toxicity was present in two patients with grade 3 temporal lobe necrosis. (4) Conclusions: Hypofractionated proton therapy is showing encouraging preliminary results. However, to fully assess the efficacy of this therapeutic approach, future trials with adequate sample sizes and extended follow-ups are necessary.
（1）背景：本研究旨在描述一项针对颅底脊索瘤和软骨肉瘤的五次分割质子治疗II期临床试验设计方案，并报告首个前瞻性病例系列在局部控制和临床耐受性方面的早期结果。（2）方法：脊索瘤处方剂量为37.5 GyRBE/5次，软骨肉瘤为35 GyRBE/5次。纳入标准包括：年龄≥18岁、卡氏功能状态评分≥70%、临床靶区体积≤50 cc且符合危及器官剂量限制要求。治疗计划采用笔形束扫描技术，使用4-6个照射野。（3）结果：共纳入11例患者（6例脊索瘤，5例软骨肉瘤）。中位随访时间12个月（9-15个月），局部控制率达100%。急性毒性包括：I-II级头痛（64%）、I级乏力与脱发（45%）、I级恶心（27%）及I级吞咽困难（18%）。2例患者出现3级颞叶坏死晚期毒性。（4）结论：大分割质子治疗显示出令人鼓舞的初步疗效，但需通过扩大样本量和延长随访期的后续试验来全面评估该治疗方案的临床价值。
肿瘤(癌症)患者之家