Department of Radiation Oncology, University of Heidelberg Medical Center, Im Neuenheimer Feld 400, Heidelberg, 69120, Germany.
BMC Cancer. 2013 Jul 15;13:345. doi: 10.1186/1471-2407-13-345.
In order to improve the clinical outcome of patients with locally advanced squamous cell carcinoma of the head and neck (LASCCHN) not being capable to receive platinum-based chemoradiation, radiotherapy can be intensified by addition of cetuximab, a monoclonal antibody that blocks the epidermal growth factor receptor (EGFR). The radioimmunotherapy with cetuximab is a feasible treatment option showing a favourable toxicity profile. The most frequent side effect of radiotherapy is radiation dermatitis, the most common side effect of treatment with cetuximab is acneiform rash. Incidence and severity of these frequent, often overlapping and sometimes limiting skin reactions, however, are not well explored. A clinical and molecular differentiation between radiogenic skin reactions and skin reactions caused by cetuximab which may correlate with outcome, have never been described before.
METHODS/DESIGN: The HICARE study is a national, multicenter, prospective phase IV study exploring the different types of skin reactions that occur in patients with LASCCHN undergoing radioimmun(chemo)therapy with the EGFR inhibitor cetuximab. 500 patients with LASCCHN will be enrolled in 40 participating sites in Germany. Primary endpoint is the rate of radiation dermatitis NCI CTCAE grade 3 and 4 (v. 4.02). Radioimmunotherapy will be applied according to SmPC, i.e. cetuximab will be administered as loading dose and then weekly during the radiotherapy. Irradiation will be applied as intensity-modulated radiation therapy (IMRT) or 3D-dimensional radiation therapy.
The HICARE trial is expected to be one of the largest trials ever conducted in head and neck cancer patients. The goal of the HICARE trial is to differentiate skin reactions caused by radiation from those caused by the monoclonal antibody cetuximab, to evaluate the incidence and severity of these skin reactions and to correlate them with outcome parameters. Besides, the translational research program will help to identify and confirm novel peripheral blood based molecular predictors and surrogates for treatment response and resistance.
Clinical Trial Identifier, NCT01553032 (clinicaltrials.gov)EudraCT number: 2010-019748-38.
为了提高无法接受铂类放化疗的局部晚期头颈部鳞状细胞癌（LASCCHN）患者的临床预后，可以通过添加阻断表皮生长因子受体（EGFR）的单克隆抗体西妥昔单抗来增强放疗。西妥昔单抗的放免疫治疗是一种可行的治疗选择，具有良好的毒性特征。放疗最常见的副作用是放射性皮炎，西妥昔单抗治疗最常见的副作用是痤疮样皮疹。然而，这些频繁、常重叠且有时会限制的皮肤反应的发生率和严重程度尚未得到充分探讨。目前尚未对放射引起的皮肤反应和由西妥昔单抗引起的皮肤反应进行临床和分子区分，而这些反应可能与预后相关。
方法/设计：HICARE 研究是一项全国性、多中心、前瞻性的 IV 期研究，旨在探讨接受 EGFR 抑制剂西妥昔单抗进行放免疫（化疗）治疗的 LASCCHN 患者中发生的不同类型的皮肤反应。该研究将在德国的 40 个参与站点招募 500 名 LASCCHN 患者。主要终点是美国国家癌症研究所不良事件通用术语标准（CTCAE）第 4.02 版中 3 级和 4 级放射性皮炎的发生率。放免疫治疗将根据 SmPC 进行应用，即西妥昔单抗将作为负荷剂量给予，然后在放疗期间每周给予一次。照射将采用调强放疗（IMRT）或三维放疗（3D 放疗）进行。
HICARE 试验预计将成为头颈部癌症患者中进行的最大规模试验之一。HICARE 试验的目标是区分由辐射引起的皮肤反应和由单克隆抗体西妥昔单抗引起的皮肤反应，评估这些皮肤反应的发生率和严重程度，并将其与预后参数相关联。此外，转化研究计划将有助于确定和确认新的外周血基于分子预测因子和替代物，以预测治疗反应和耐药性。
临床试验标识符，NCT01553032（clinicaltrials.gov）；EudraCT 编号：2010-019748-38。
