Kirisits Christian, Federico Mario, Nkiwane Karen, Fidarova Elena, Jürgenliemk-Schulz Ina, de Leeuw Astrid, Lindegaard Jacob, Pötter Richard, Tanderup Kari
Department of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna, Austria.
Department of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna, Austria; Radiation Oncology Department, HUGC Dr. Negrin, Las Palmas, Spain.
Radiother Oncol. 2015 Dec;117(3):548-54. doi: 10.1016/j.radonc.2015.08.001. Epub 2015 Aug 24.
Upfront quality assurance (QA) is considered essential when starting a multicenter clinical trial in radiotherapy. Despite the long experience gained for external beam radiotherapy (EBRT) trials, there are only limited audit QA methods for brachytherapy (BT) and none include the specific aspects of image guided adaptive brachytherapy (IGABT).
EMBRACE is a prospective multicenter trial aiming to assess the impact of (MRI)-based IGABT in locally advanced cervical cancer. An EMBRACE dummy run was designed to identify sources and magnitude of uncertainties and errors considered important for the evaluation of clinical, and dosimetric parameters and their relation to outcome. Contouring, treatment planning and dose reporting was evaluated and scored with a categorical scale of 1-10. Active feedback to centers was provided to improve protocol compliance and reporting. A second dummy run was required in case of major deviations (score <7) for any item.
Overall 27/30 centers passed the dummy run. 16 centers had to repeat the dummy run in order to clarify major inconsistencies to the protocol. The most pronounced variations were related to contouring for both EBRT and BT. Centers with experience in IGABT (>30 cases) had better performance as compared to centers with limited experience.
The comprehensive dummy run designed for the EMBRACE trial has been a feasible tool for QA in IGABT of cervix cancer. It should be considered for future IGABT trials and could serve as the basis for continuous quality checks for brachytherapy centers.
在开展放射治疗多中心临床试验时，前期质量保证（QA）被认为至关重要。尽管在外照射放疗（EBRT）试验方面积累了丰富经验，但近距离放疗（BT）的审核QA方法有限，且没有一种方法涵盖图像引导自适应近距离放疗（IGABT）的具体方面。
EMBRACE是一项前瞻性多中心试验，旨在评估基于磁共振成像（MRI）的IGABT对局部晚期宫颈癌的影响。设计了一次EMBRACE预试验，以确定对于评估临床和剂量学参数及其与预后的关系而言重要的不确定性和误差的来源及程度。对轮廓勾画、治疗计划和剂量报告进行评估，并采用1至10的分类量表评分。向各中心提供积极反馈，以提高方案依从性和报告质量。若任何项目出现重大偏差（评分<7），则需要进行第二次预试验。
总体而言，30个中心中有27个通过了预试验。16个中心必须重复预试验，以澄清与方案的重大不一致之处。最明显的差异与EBRT和BT的轮廓勾画有关。与经验有限的中心相比，有IGABT经验（>30例）的中心表现更好。
为EMBRACE试验设计的全面预试验是宫颈癌IGABT质量保证的一种可行工具。应考虑将其用于未来的IGABT试验，并可作为近距离放疗中心持续质量检查的基础。
