3D 打印个体化牙支持式组织牵张器与传统牙科夹板用于头颈部癌症放疗的比较：一项随机对照试验。
3D-printed individualized tooth-borne tissue retraction devices compared to conventional dental splints for head and neck cancer radiotherapy: a randomized controlled trial.
机构信息
Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany.
出版信息
Radiat Oncol. 2021 Apr 17;16(1):75. doi: 10.1186/s13014-021-01803-8.
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.
DISCUSSION
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.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT04454697; July 1 2020; https://clinicaltrials.gov/ct2/show/record/NCT04454697 .
背景
尽管采用了现代治疗技术，头颈部癌症（HNC）患者的放射治疗（RT）仍可能导致较高的急性和晚期治疗相关毒性。降低 RT 后后遗症的最有效方法是尽可能避免将健康组织和器官置于辐射靶区的风险中。即使是微小的几何变化也会导致正常组织的剂量显著减少，从而提高治疗耐受性。目前研究的主要目的是研究 3D 打印的、牙支撑的组织牵拉装置（TRD）与头颈部 RT 相比的常规牙夹板。
方法
在目前的、双臂、随机对照的 II 期试验中，最多将有 34 名 HNC 患者入组。患者将接受 TRD 或常规牙夹板（随机化比例为 1:1）用于 RT。靶区的定义、方式、总剂量、分割和成像引导不是研究特定的。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。RT 后 12 个月的生活质量、局部控制和总生存率是次要终点。此外，还将评估患者报告的结果和牙科状况，以及 RT 计划比较和稳健性分析，作为探索性终点。最后，将从患者的牙龈中分离的间充质干细胞在体外进行再生和放射防护特性的测试。
讨论
TRD 的初步临床应用显示出降低 HNC 患者 RT 急性和晚期毒性的高潜力。目前的前瞻性研究首次调查了 TRD 对头颈部肿瘤放射治疗的临床耐受性和疗效。
试验注册
ClinicalTrials.gov；NCT04454697；2020 年 7 月 1 日；https://clinicaltrials.gov/ct2/show/record/NCT04454697。
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