背景:尽管采用了现代治疗技术,头颈部肿瘤(HNC)患者的放疗(RT)可能与急性和晚期治疗相关的高毒性相关。减少RT后后遗症的最有效方法是尽可能避免辐射目标体积中处于危险中的健康组织和器官。即使很小的几何变化也可以导致正常组织中的显著剂量减少和更好的治疗耐受性。当前研究的主要目标是研究3D打印,与用于头颈部RT的常规牙科夹板相比,牙载组织牵开装置(TRD)。
方法:在目前的双臂随机对照II期试验中,最多将纳入34例HNC患者.患者将接受TRD或常规牙科夹板(随机比例为1:1)的RT。目标体积的定义,模态,总剂量,分馏,和成像指导不是研究特定的。该研究的主要终点是RT后急性放射性口腔黏膜炎的发生率。生活的质量,局部控制和RT后12个月的总生存期是次要终点.此外,患者报告的结果和牙科状态,以及RT计划比较和鲁棒性分析,将被评估为探索性终点。最后,间充质干细胞,来源于病人的牙龈,将在体外测试再生和辐射防护性能。
结论:TRD的初步临床应用显示出降低HNC患者RT的急性和晚期毒性的潜力。目前的随机研究是第一个前瞻性研究TRD用于头颈部肿瘤放射治疗的临床耐受性和疗效。
背景:ClinicalTrials.gov;NCT04454697;2020年7月1日;https://clinicaltrials.gov/ct2/show/record/NCT04454697。
BACKGROUND: Despite modern treatment techniques, radiotherapy (RT) in patients with head and neck cancer (HNC) may be associated with high rates of acute and late treatment-related toxicity. The most effective approach to reduce sequelae after RT is to avoid as best as possible healthy tissues and organs at risk from the radiation target volume. Even small geometric changes can lead to a significant dose reduction in normal tissue and better treatment tolerability. The major objective of the current
study is to investigate 3D printed, tooth-borne tissue retraction devices (TRDs) compared to conventional dental splints for head and neck RT.
METHODS: In the current two-arm randomized controlled phase II
trial, a maximum of 34 patients with HNC will be enrolled. Patients will receive either TRDs or conventional dental splints (randomization ratio 1:1) for the RT. The definition of the target volume, modality, total dose, fractionation, and imaging guidance is not
study-specific. The primary endpoint of the
study is the rate of acute radiation-induced oral mucositis after RT. The quality of life, local control and overall survival 12 months after RT are the secondary endpoints. Also, patient-reported outcomes and dental status, as well as RT plan comparisons and robustness analyzes, will be assessed as exploratory endpoints. Finally, mesenchymal stem cells, derived from the patients\' gingiva, will be tested in vitro for regenerative and radioprotective properties.
CONCLUSIONS: The preliminary clinical application of TRD showed a high potential for reducing acute and late toxicity of RT in patients with HNC. The current randomized
study is the first to prospectively investigate the clinical tolerability and efficacy of TRDs for radiation treatment of head and neck tumors.
BACKGROUND: ClinicalTrials.gov; NCT04454697; July 1st 2020; https://clinicaltrials.gov/ct2/show/record/NCT04454697 .