Geneva University Hospital, Switzerland.
Radiother Oncol. 2012 Oct;105(1):4-8. doi: 10.1016/j.radonc.2012.08.008. Epub 2012 Sep 14.
Quality assurance (QA) for radiation therapy (RT) in clinical trials is necessary to ensure treatment is safely and effectively administered. QA assurance requires however substantial human and financial resources, as it has become more comprehensive and labor intensive in recent RT trials. It is presumed that RT deviations decrease therapeutic effectiveness of the studied regimen. This study assesses the impact of RT protocol-deviations on patient's outcome in prospective phase II-III RT trials. PubMed, Medline and Embase identified nine prospective RT trials detailing QA RT violation and patient's outcome. Planned QA analysis was preformed retrospectively and prospectively in eight and one studies, respectively. Non-adherence to protocol-specified RT requirements in prospective trials is frequent: the observed major deviation rates range from 11.8% to 48.0% (mean, 28.1 ± 17.9%). QA RT deviations had a significant impact on the primary study end-point in a majority (62.5%) of studies. The number of patients accrued per center was a significant predictive factor for RT deviations in the largest series. These QA data stemming from prospective clinical trials show undisputedly that non adherence to protocol-specified RT requirements is associated with reduced survival, local control and potentially increased toxicity.
质量保证（QA）对于临床试验中的放射治疗（RT）是必要的，以确保治疗安全有效地进行。然而，QA 保证需要大量的人力和财力，因为它在最近的 RT 试验中变得更加全面和劳动密集。人们推测 RT 偏差会降低所研究方案的治疗效果。本研究评估了 RT 方案偏差对前瞻性 II-III 期 RT 试验中患者结局的影响。通过 PubMed、Medline 和 Embase 确定了九项详细描述 QA RT 违规和患者结局的前瞻性 RT 试验。分别对 8 项和 1 项研究进行了计划 QA 分析的回顾性和前瞻性分析。前瞻性试验中不遵守协议规定的 RT 要求很常见：观察到的主要偏差率范围为 11.8%至 48.0%（平均值为 28.1±17.9%）。QA RT 偏差在大多数研究（62.5%）中对主要研究终点有显著影响。在最大的系列中，每个中心积累的患者数量是 RT 偏差的一个显著预测因素。这些来自前瞻性临床试验的 QA 数据无可争议地表明，不遵守协议规定的 RT 要求与降低生存率、局部控制率以及潜在增加毒性有关。
