PDF(Pubmed)
Abstract：
UNASSIGNED: The long-term complication rate in head-and-neck squamous cell carcinoma (HNSCC) patients caused by radiotherapy (RT) can be decreased by restricting elective neck irradiation (ENI) from large adjacent lymph node levels to only individual elective lymph nodes. The primary objective of this study is to treat the first HNSCC patients with individual elective lymph node irradiation by means of a Magnetic Resonance-linac (MR-linac) in order to assess the feasibility.
UNASSIGNED: In this phase I feasibility study, 20 patients will be included with histologically proven cT2-4N0-1M0 HNSCC originating from the oropharynx, hypopharynx or larynx, planned for treatment with primary radiotherapy and bilateral elective neck irradiation (ENI). Patients will be treated with 35 fractions in six weeks, according to the DAHANCA schedule. Individual lymph nodes inside the conventional lymph node levels will be categorized in low-risk, intermediate-risk and high-risk based on cytology, histology and imaging parameters. Low-risk and intermediate-risk lymph nodes will irradiated in 20 and 23 fractions respectively, with a fraction dose of 2 Gy (=40/46 Gy EQD2). The high-risk lymph nodes and the primary tumor will be irradiated in 35 fractions of 2 Gy (=70 Gy equivalent dose in 2 Gy fractions (EQD2)). To limit treatment burden, 20 fractions will be applied on the MR-linac. The last 15 fractions (sequential boost at the primary tumor, intermediate-risk and high-risk lymph nodes) will be applied on a conventional linear accelerator. The main study endpoint is the percentage of fractions that are successfully completed on the MR-linac.
UNASSIGNED: With individual elective lymph node irradiation we expect less toxicity and a better quality of life for HNSCC patients. However, as the treatment time on the MR-linac will be longer (30-45 vs 15 min per fraction) we need to examine if patients can endure this new treatment concept.
UNASSIGNED: In this phase I feasibility study, 20 patients will be included with histologically proven cT2-4N0-1M0 HNSCC originating from the oropharynx, hypopharynx or larynx, planned for treatment with primary radiotherapy and bilateral elective neck irradiation (ENI). Patients will be treated with 35 fractions in six weeks, according to the DAHANCA schedule. Individual lymph nodes inside the conventional lymph node levels will be categorized in low-risk, intermediate-risk and high-risk based on cytology, histology and imaging parameters. Low-risk and intermediate-risk lymph nodes will irradiated in 20 and 23 fractions respectively, with a fraction dose of 2 Gy (=40/46 Gy EQD2). The high-risk lymph nodes and the primary tumor will be irradiated in 35 fractions of 2 Gy (=70 Gy equivalent dose in 2 Gy fractions (EQD2)). To limit treatment burden, 20 fractions will be applied on the MR-linac. The last 15 fractions (sequential boost at the primary tumor, intermediate-risk and high-risk lymph nodes) will be applied on a conventional linear accelerator. The main study endpoint is the percentage of fractions that are successfully completed on the MR-linac.
UNASSIGNED: With individual elective lymph node irradiation we expect less toxicity and a better quality of life for HNSCC patients. However, as the treatment time on the MR-linac will be longer (30-45 vs 15 min per fraction) we need to examine if patients can endure this new treatment concept.
摘要：
UNASSIGNED：头颈部鳞状细胞癌（HNSCC）患者由放疗（RT）引起的长期并发症的发生率可以通过将选择性颈部放疗（ENI）从较大的邻近淋巴结水平限制为仅个别选择性淋巴结来降低。这项研究的主要目的是通过磁共振直线加速器（MR直线加速器）对首例HNSCC患者进行单独的选择性淋巴结照射，以评估可行性。
未经批准：在第一阶段的可行性研究中，20例患者将被纳入组织学证实的cT2-4N0-1M0HNSCC源自口咽，下咽或喉，计划进行初次放疗和双侧选择性颈部放疗（ENI）治疗。患者将在六周内接受35分的治疗，根据DAHANCA时间表。常规淋巴结水平内的单个淋巴结将被分类为低风险，基于细胞学的中危和高危，组织学和成像参数。低危和中危淋巴结将分别照射20和23个部位，2Gy的部分剂量（=40/46GyEQD2）。高风险淋巴结和原发性肿瘤将在35个2Gy部分(=70Gy等效剂量在2Gy部分(EQD2))中进行照射。为了限制治疗负担，20个部分将被应用在MR-直线加速器上。最后15个部分(原发肿瘤的顺序加强，中等风险和高风险淋巴结）将应用于传统的线性加速器。主要研究终点是在MR直线加速器上成功完成的分数的百分比。
UNASSIGNED：通过单独的选择性淋巴结照射，我们期望HNSCC患者的毒性更低，生活质量更好。然而,由于MR-linac的治疗时间将更长（每分30-45vs15分钟），我们需要检查患者是否可以忍受这种新的治疗概念。
未经批准：在第一阶段的可行性研究中，20例患者将被纳入组织学证实的cT2-4N0-1M0HNSCC源自口咽，下咽或喉，计划进行初次放疗和双侧选择性颈部放疗（ENI）治疗。患者将在六周内接受35分的治疗，根据DAHANCA时间表。常规淋巴结水平内的单个淋巴结将被分类为低风险，基于细胞学的中危和高危，组织学和成像参数。低危和中危淋巴结将分别照射20和23个部位，2Gy的部分剂量（=40/46GyEQD2）。高风险淋巴结和原发性肿瘤将在35个2Gy部分(=70Gy等效剂量在2Gy部分(EQD2))中进行照射。为了限制治疗负担，20个部分将被应用在MR-直线加速器上。最后15个部分(原发肿瘤的顺序加强，中等风险和高风险淋巴结）将应用于传统的线性加速器。主要研究终点是在MR直线加速器上成功完成的分数的百分比。
UNASSIGNED：通过单独的选择性淋巴结照射，我们期望HNSCC患者的毒性更低，生活质量更好。然而,由于MR-linac的治疗时间将更长（每分30-45vs15分钟），我们需要检查患者是否可以忍受这种新的治疗概念。
