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Combining Dosimetry Toxicity: Analysis of two UK Phase III Clinical trials

机译：结合剂量测定和毒性：两个英国第三期临床试验分析

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There are many advantages to performing a clinical trial when implementing a novel radiotherapy technique. The clinical trials framework enables the safety and efficacy of the "experimental arm" to be tested and ensures practical support, rigorous quality control and data monitoring for participating centres. In addition to the clinical and follow-up data collected from patients within the trial, it is also possible to collect 3-D dosimetric information from the corresponding radiotherapy treatment plans. Analysing the combination of dosimetric, clinical and follow-up data enhances the understanding of the relationship between the dose delivered to both the target and normal tissue structures and reported outcomes & toxicity. Aspects of the collection, collation and analysis of data from two UK multicentre Phase III radiotherapy trials are presented here. MRC-RT01 dose-escalation prostate radiotherapy trial ISRCTN47772397 was one of the first UK multi-centre radiotherapy trials to collect 3-D dosimetric data. A number of different analysis methodologies were implemented to investigate the relationship between the dose distribution to the rectum and specific rectal toxicities. More recently data was collected from the PARSPORT trial (Parotid Sparing IMRT vs conventional head and neck radiotherapy) ISRCTN48243537. In addition to the planned analysis, dosimetric analysis was employed to investigate an unexpected finding that acute fatigue was more prevalent in the IMRT arm of the trial. It can be challenging to collect 3-D dosimetric information from multicentre radiotherapy trials. However, analysing the relationship between dosimetric and toxicity data provides invaluable information which can influence the next generation of radiotherapy techniques.
机译：在实施新的放射治疗技术时进行临床试验许多优点。临床试验框架可以测试“实验臂”的安全性和功效，并确保参与中心的实际支持，严格的质量控制和数据监测。除了从试验中的患者收集的临床和后续数据外，还可以从相应的放射治疗计划中收集3-D剂量信息。剂量学分析，临床和后续数据的组合增强递送到目标都与正常组织结构和报告的结果和毒性剂量之间的关系的理解。这里提出了来自两个英国多元相III放射治疗试验的数据收集，整理和分析的各个集合和分析。 MRC-RT01剂量 - 升级前列腺放射治疗试验ISRCTN47772397是第一个收集3-D剂量数据的英国多中心放射治疗试验之一。实施了许多不同的分析方法，以研究剂量分布与直肠和特异性直肠毒性之间的关系。从Parsport试验（腮腺保留IMRT VS常规头部和颈部放射疗法）中收集了更多最近的数据，ISRCTN48243537。除了计划的分析外，使用剂量测定分析来研究意外发现，在试验的IMRT手臂中急性疲劳更为普遍。收集来自多中心放疗试验的三维剂量信息可能具有挑战性。然而，分析剂量测定和毒性数据之间的关系提供了可以影响下一代放射治疗技术的宝贵信息。

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