Challenges for Quality Assurance of Target Volume Delineation in Clinical Trials.

Challenges for Quality Assurance of Target Volume Delineation in Clinical Trials.
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DOI:
10.3389/fonc.2017.00221
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发表时间:
2017
影响因子:
4.7
通讯作者:
Ng WT
Ng WT
中科院分区:
医学3区
文献类型:
--
作者:
Chang ATY;Tan LT;Duke S;Ng WT

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近年来,出现了新的放射治疗技术,旨在改善治疗效果和减少毒性。评估这些技术的标准方法是进行大规模的多中心临床试验,通常是跨大洲的。此类试验的主要挑战是质量保证,以确保所有参与中心的治疗一致性。既往研究的分析表明,依从性差和方案违背对治疗结果有显著的不良影响。因此,临床试验的结果可能会受到低质量放射治疗的混淆。靶区勾画(TVD)是放射治疗过程中最关键的步骤之一。许多研究表明,在临床试验内外,观察者之间的轮廓绘制存在较大差异。高精度技术,如调强放射治疗、图像引导近距离放射治疗和立体定向放射治疗具有陡峭的剂量梯度,轮廓绘制中的误差可能导致对肿瘤的剂量不足,从而降低治愈的机会。类似地,风险器官描述的变化将使得难以评价毒性的剂量反应。本文综述了有关TVD变异性及其对剂量测定和临床结局的影响的文献。临床试验质量保证的影响进行了讨论。
In recent years, new radiotherapy techniques have emerged that aim to improve treatment outcome and reduce toxicity. The standard method of evaluating such techniques is to conduct large scale multicenter clinical trials, often across continents. A major challenge for such trials is quality assurance to ensure consistency of treatment across all participating centers. Analyses from previous studies have shown that poor compliance and protocol violation have a significant adverse effect on treatment outcomes. The results of the clinical trials may, therefore, be confounded by poor quality radiotherapy. Target volume delineation (TVD) is one of the most critical steps in the radiotherapy process. Many studies have shown large inter-observer variations in contouring, both within and outside of clinical trials. High precision techniques, such as intensity-modulated radiotherapy, image-guided brachytherapy, and stereotactic radiotherapy have steep dose gradients, and errors in contouring may lead to inadequate dose to the tumor and consequently, reduce the chance of cure. Similarly, variation in organ at risk delineation will make it difficult to evaluate dose response for toxicity. This article reviews the literature on TVD variability and its impact on dosimetry and clinical outcomes. The implications for quality assurance in clinical trials are discussed.
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