放疗相关皮肤毒性（RAREST-01）：局部晚期头颈部癌患者的 Mepitel®薄膜与标准护理的比较。
Radiotherapy related skin toxicity (RAREST-01): Mepitel® film versus standard care in patients with locally advanced head-and-neck cancer.
机构信息
Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, D-23562, Lübeck, Germany.
Departments of Radiation Oncology and Oto-Rhino-Laryngology and Head and Neck Surgery, University of Lübeck, Lübeck, Germany.
出版信息
BMC Cancer. 2018 Feb 17;18(1):197. doi: 10.1186/s12885-018-4119-x.
BACKGROUND
The aim of the present trial is to investigate a new option of skin protection in order to reduce the rate of grade ≥ 2 skin toxicity in patients receiving radiotherapy alone or radiochemotherapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).
METHODS / DESIGN: This is a randomized, active-controlled, parallel-group multi-center trial that compares the following treatments of radiation dermatitis in patients with head-and-neck cancer: Mepitel® Film (Arm A) vs. standard care (Arm B). The primary aim of this trial is to investigate the rate of patients experiencing grade ≥ 2 radiation dermatitis (according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03) until 50 Gy of radiotherapy. Evaluation until 50 Gy of radiotherapy has been selected as the primary endpoint, since up to 50 Gy, the irradiated volume includes the primary tumor and the bilateral cervical and supraclavicular lymph nodes, and, therefore, is similar in all patients. After 50 Gy, irradiated volumes are very individual, depending on location and size of the primary tumor, involvement of lymph nodes, and the treatment approach (definitive vs. adjuvant). In addition, the following endpoints will be evaluated: Time to grade 2 radiation dermatitis until 50 Gy of radiotherapy, rate of patients experiencing grade ≥ 2 radiation dermatitis during radio(chemo)therapy, rate of patients experiencing grade ≥ 3 skin toxicity during radio(chemo)therapy, adverse events, quality of life, and dermatitis-related pain. Administration of Mepitel® Film will be considered to be clinically relevant, if the rate of grade ≥ 2 radiation dermatitis can be reduced from 85% to 65%.
DISCUSSION
If administration of Mepitel® Film instead of standard care will be able to significantly reduce the rate of grade ≥ 2 radiation dermatitis, it could become the new standard of skin care in patients irradiated for SCCHN.
TRIAL REGISTRATION
clinicaltrials.gov NCT03047174 . Registered on 26th of January, 2017. First patient included on 9th of May, 2017.
背景
本试验旨在研究一种新的皮肤保护方法，以降低单独接受放疗或放化疗的局部晚期头颈部鳞状细胞癌（SCCHN）患者的 2 级以上皮肤毒性发生率。
方法/设计：这是一项随机、活性对照、平行组多中心试验，比较了头颈部癌患者放射性皮炎的以下治疗方法：Mepitel®膜（A 组）与标准护理（B 组）。本试验的主要目的是研究直至放疗 50Gy 时患者发生 2 级以上放射性皮炎的比例（根据不良事件通用毒性标准（CTCAE）第 4.03 版）。选择评估直至 50Gy 的放疗作为主要终点，因为在 50Gy 之前，照射体积包括原发肿瘤和双侧颈淋巴结和锁骨上淋巴结，因此所有患者的照射体积相似。在 50Gy 之后，照射体积非常个体化，取决于原发肿瘤的位置和大小、淋巴结受累情况以及治疗方法（根治性与辅助性）。此外，还将评估以下终点：直至 50Gy 的放疗时 2 级放射性皮炎的发生时间、放疗期间发生 2 级以上放射性皮炎的患者比例、放疗期间发生 3 级以上皮肤毒性的患者比例、不良事件、生活质量和与皮炎相关的疼痛。如果 Mepitel®膜的使用能将 2 级以上放射性皮炎的发生率从 85%降低到 65%，则认为其具有临床意义。
讨论
如果 Mepitel®膜的使用能显著降低 2 级以上放射性皮炎的发生率，它可能成为 SCCHN 放疗患者新的皮肤护理标准。
试验注册
clinicaltrials.gov NCT03047174。于 2017 年 1 月 26 日注册。第一位患者于 2017 年 5 月 9 日入组。
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