Jameson Michael G, McNamara Jo, Bailey Michael, Metcalfe Peter E, Holloway Lois C, Foo Kerwyn, Do Viet, Mileshkin Linda, Creutzberg Carien L, Khaw Pearly
Centre for Medical Radiation Physics, University of Wollongong, Wollongong, New South Wales, Australia.
Liverpool Cancer Therapy Centre, Liverpool, New South Wales, Australia.
J Med Imaging Radiat Oncol. 2016 Aug;60(4):554-9. doi: 10.1111/1754-9485.12447. Epub 2016 Apr 5.
Protocol deviations in Randomised Controlled Trials have been found to result in a significant decrease in survival and local control. In some cases, the magnitude of the detrimental effect can be larger than the anticipated benefits of the interventions involved. The implementation of appropriate quality assurance of radiotherapy measures for clinical trials has been found to result in fewer deviations from protocol. This paper reports on a benchmarking study conducted in preparation for the PORTEC-3 trial in Australasia.
A benchmarking CT dataset was sent to each of the Australasian investigators, it was requested they contour and plan the case according to trial protocol using local treatment planning systems. These data was then sent back to Trans-Tasman Oncology Group for collation and analysis.
Thirty three investigators from eighteen institutions across Australia and New Zealand took part in the study. The mean clinical target volume (CTV) volume was 383.4 (228.5-497.8) cm(3) and the mean dose to a reference gold standard CTV was 48.8 (46.4-50.3) Gy.
Although there were some large differences in the contouring of the CTV and its constituent parts, these did not translate into large variations in dosimetry. Where individual investigators had deviations from the trial contouring protocol, feedback was provided. The results of this study will be used to compare with the international study QA for the PORTEC-3 trial.
随机对照试验中的方案偏差已被发现会导致生存率和局部控制率显著下降。在某些情况下,有害影响的程度可能大于所涉及干预措施的预期益处。已发现对临床试验放疗措施实施适当的质量保证可减少与方案的偏差。本文报告了一项为澳大利亚和新西兰的PORTEC-3试验做准备而进行的基准研究。
向澳大利亚和新西兰的每位研究者发送了一个基准CT数据集,要求他们使用当地的治疗计划系统根据试验方案勾勒靶区轮廓并制定治疗计划。然后将这些数据发送回跨塔斯曼肿瘤学组进行整理和分析。
来自澳大利亚和新西兰18个机构的33名研究者参与了该研究。临床靶区(CTV)的平均体积为383.4(228.5 - 497.8)cm³,参考金标准CTV的平均剂量为48.8(46.4 - 50.3)Gy。
尽管CTV及其组成部分的轮廓勾勒存在一些较大差异,但这些并未转化为剂量学上的巨大变化。对于个别研究者偏离试验轮廓勾勒方案的情况,已提供了反馈。本研究结果将用于与PORTEC-3试验的国际研究质量保证进行比较。