DARS: a phase III randomised multicentre study of dysphagia- optimised intensity- modulated radiotherapy (Do-IMRT) versus standard intensity- modulated radiotherapy (S-IMRT) in head and neck cancer.
DARS: a phase III randomised multicentre study of dysphagia- optimised intensity- modulated radiotherapy (Do-IMRT) versus standard intensity- modulated radiotherapy (S-IMRT) in head and neck cancer.
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DARS：在头部和颈部癌中，对吞咽障碍强度调制放射疗法（DO-IMRT）与标准强度调制放射疗法（S-IMRT）的III期随机多中心研究。
DOI：
10.1186/s12885-016-2813-0
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发表时间：
2016-10-06
期刊：
影响因子：
3.8
通讯作者：
Nutting CM
中科院分区：
文献类型：
--
作者：
Petkar I;Rooney K;Roe JW;Patterson JM;Bernstein D;Tyler JM;Emson MA;Morden JP;Mertens K;Miles E;Beasley M;Roques T;Bhide SA;Newbold KL;Harrington KJ;Hall E;Nutting CM
原发性头颈癌放化疗（CRT）后持续性吞咽困难可能对患者的生活质量产生毁灭性影响。单组研究表明，保留关键吞咽结构（例如咽缩肌和声门上喉）的剂量测定可以转化为更好的功能结果。然而，目前还没有随机研究来证实这种吞咽节省策略的益处。吞咽困难/危险结构误吸（DARS）试验的目的是确定通过吞咽困难优化调强放疗（Do-IMRT）降低咽缩肌剂量是否会改善长期吞咽功能，而不会对疾病特异性生存结局产生任何不利影响。DARS试验（CRUK/14/014）是一项III期多中心随机对照试验（RCT），针对T1-4、N 0 -3、M0咽癌接受初次（化疗）放疗的患者。患者将随机（1：1比例）接受标准IMRT（S-IMRT）或Do-IMRT。两组的放射治疗剂量相同;然而，在分配至Do-IMRT的患者中，通过实施IMRT将咽肌识别为风险器官，从而减少咽肌组织的辐射。试验的主要终点是平均MD安德森吞咽困难量表（MDADI）综合评分的差异，这是一种患者报告的结局，在放疗后12个月测量。次要终点包括吞咽结局的前瞻性和纵向评价，包括一系列主观和客观评估、生活质量指标、局部区域控制和总生存期。患者和言语和语言治疗师（SLT）均对治疗分配组设盲，以尽量减少结局报告偏倚。DARS是第一个研究吞咽保留策略对改善咽癌长期吞咽结局的影响的RCT。该研究的一个组成部分是吞咽评估的多维方法，为未来吞咽结果测量的标准化提供了可靠的数据。还计划进行一项转化子研究，该研究可能导致未来预测和预后生物标志物的开发。本研究已在国际标准随机对照试验登记册ISRCTN 25458988中注册（2016年4月1日）
Persistent dysphagia following primary chemoradiation (CRT) for head and neck cancers can have a devastating impact on patients’ quality of life. Single arm studies have shown that the dosimetric sparing of critical swallowing structures such as the pharyngeal constrictor muscle and supraglottic larynx can translate to better functional outcomes. However, there are no current randomised studies to confirm the benefits of such swallow sparing strategies. The aim of Dysphagia/Aspiration at risk structures (DARS) trial is to determine whether reducing the dose to the pharyngeal constrictors with dysphagia-optimised intensity- modulated radiotherapy (Do-IMRT) will lead to an improvement in long- term swallowing function without having any detrimental impact on disease-specific survival outcomes. The DARS trial (CRUK/14/014) is a phase III multicentre randomised controlled trial (RCT) for patients undergoing primary (chemo) radiotherapy for T1-4, N0-3, M0 pharyngeal cancers. Patients will be randomised (1:1 ratio) to either standard IMRT (S-IMRT) or Do-IMRT. Radiotherapy doses will be the same in both groups; however in patients allocated to Do-IMRT, irradiation of the pharyngeal musculature will be reduced by delivering IMRT identifying the pharyngeal muscles as organs at risk. The primary endpoint of the trial is the difference in the mean MD Anderson Dysphagia Inventory (MDADI) composite score, a patient-reported outcome, measured at 12 months post radiotherapy. Secondary endpoints include prospective and longitudinal evaluation of swallow outcomes incorporating a range of subjective and objective assessments, quality of life measures, loco-regional control and overall survival. Patients and speech and language therapists (SLTs) will both be blinded to treatment allocation arm to minimise outcome-reporting bias. DARS is the first RCT investigating the effect of swallow sparing strategies on improving long-term swallowing outcomes in pharyngeal cancers. An integral part of the study is the multidimensional approach to swallowing assessment, providing robust data for the standardisation of future swallow outcome measures. A translational sub- study, which may lead to the development of future predictive and prognostic biomarkers, is also planned. This study is registered with the International Standard Randomised Controlled Trial register, ISRCTN25458988 (04/01/2016)
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DOI：
10.1002/hed.23275
发表时间：
2014-01-01
影响因子：
2.9
作者：
Hunter, Klaudia U.;Lee, Oliver E.;Eisbruch, Avraham
通讯作者：
Eisbruch, Avraham
DOI：
10.1200/jco.2015.61.2358
发表时间：
2015-10-10
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Bhatia A;Burtness B
通讯作者：
Burtness B
影响因子：
5.7
作者：
Christianen, Miranda E. M. C.;Langendijk, Johannes A.;Bijl, Hendrik P.
通讯作者：
Bijl, Hendrik P.
影响因子：
4.7
作者：
Hutcheson, Katherine A.;Lewin, Jan S.
通讯作者：
Lewin, Jan S.
影响因子：
3.4
作者：
Bayman, E.;Prestwich, R. J. D.;Sen, M.
通讯作者：
Sen, M.