PDF(Pubmed)
Abstract：
UNASSIGNED: The PRIDE trial (NOA-28; ARO-2024-01; AG-NRO-06; NCT05871021) is designed to determine whether a dose escalation with 75.0 Gy in 30 fractions can enhance the median overall survival (OS) in patients with methylguanine methyltransferase (MGMT) promotor unmethylated glioblastoma compared to historical median OS rates, while being isotoxic to historical cohorts through the addition of concurrent bevacizumab (BEV). To ensure protocol-compliant irradiation planning with all study centers, a dummy run was planned and the plan quality was evaluated.
UNASSIGNED: A suitable patient case was selected and the computed tomography (CT), magnetic resonance imaging (MRI) and O-(2-[18F]fluoroethyl)-L-tyrosine (FET) positron emission tomography (PET) contours were made available. Participants at the various intended study sites performed radiation planning according to the PRIDE clinical trial protocol. The treatment plans and dose grids were uploaded as Digital Imaging and Communications in Medicine (DICOM) files to a cloud-based platform. Plan quality and protocol adherence were analyzed using a standardized checklist, scorecards and indices such as Dice Score (DSC) and Hausdorff Distance (HD).
UNASSIGNED: Median DSC was 0.89, 0.90, 0.88 for PTV60, PTV60ex (planning target volume receiving 60.0 Gy for the standard and the experimental plan, respectively) and PTV75 (PTV receiving 75.0 Gy in the experimental plan), respectively. Median HD values were 17.0 mm, 13.9 mm and 12.1 mm, respectively. These differences were also evident in the volumes: The PTV60 had a volume range of 219.1-391.3 cc (median: 261.9 cc) for the standard plans, while the PTV75 volumes for the experimental plans ranged from 71.5-142.7 cc (median: 92.3 cc). The structures with the largest deviations in Dice score were the pituitary gland (median 0.37, range 0.00-0.69) and the right lacrimal gland (median 0.59, range 0.42-0.78).
UNASSIGNED: The deviations revealed the necessity of systematic trainings with appropriate feedback before the start of clinical trials in radiation oncology and the constant monitoring of protocol compliance throw-out the study.
UNASSIGNED: NCT05871021.
UNASSIGNED: A suitable patient case was selected and the computed tomography (CT), magnetic resonance imaging (MRI) and O-(2-[18F]fluoroethyl)-L-tyrosine (FET) positron emission tomography (PET) contours were made available. Participants at the various intended study sites performed radiation planning according to the PRIDE clinical trial protocol. The treatment plans and dose grids were uploaded as Digital Imaging and Communications in Medicine (DICOM) files to a cloud-based platform. Plan quality and protocol adherence were analyzed using a standardized checklist, scorecards and indices such as Dice Score (DSC) and Hausdorff Distance (HD).
UNASSIGNED: Median DSC was 0.89, 0.90, 0.88 for PTV60, PTV60ex (planning target volume receiving 60.0 Gy for the standard and the experimental plan, respectively) and PTV75 (PTV receiving 75.0 Gy in the experimental plan), respectively. Median HD values were 17.0 mm, 13.9 mm and 12.1 mm, respectively. These differences were also evident in the volumes: The PTV60 had a volume range of 219.1-391.3 cc (median: 261.9 cc) for the standard plans, while the PTV75 volumes for the experimental plans ranged from 71.5-142.7 cc (median: 92.3 cc). The structures with the largest deviations in Dice score were the pituitary gland (median 0.37, range 0.00-0.69) and the right lacrimal gland (median 0.59, range 0.42-0.78).
UNASSIGNED: The deviations revealed the necessity of systematic trainings with appropriate feedback before the start of clinical trials in radiation oncology and the constant monitoring of protocol compliance throw-out the study.
UNASSIGNED: NCT05871021.
摘要：
■PRIDE试验（NOA-28;ARO-2024-01;AG-NRO-06;NCT05871021）旨在确定30个部分的75.0Gy剂量递增是否可以提高甲基鸟嘌呤甲基转移酶（MGMT）或未甲基化胶质母细胞瘤患者的中位总生存期（OS）与历史中位OS率相比，同时通过同时添加贝伐单抗（BEV）与历史队列具有等氧效应。为确保所有研究中心的辐照计划符合协议，计划假人运行，并评估计划质量。
■选择了合适的患者病例，并进行了计算机断层扫描（CT），磁共振成像（MRI）和O-（2-[18F]氟乙基）-L-酪氨酸（FET）正电子发射断层扫描（PET）轮廓可用。各个预期研究地点的参与者根据PRIDE临床试验方案进行了辐射计划。治疗计划和剂量网格作为医学数字成像和通信（DICOM）文件上传到基于云的平台。使用标准化检查表分析计划质量和方案依从性，记分卡和指数，如骰子得分（DSC）和豪斯多夫距离（HD）。
■PTV60、PTV60ex的DSC中位数为0.89、0.90、0.88(标准和实验计划的计划目标体积为60.0Gy,分别)和PTV75(实验计划中PTV接收75.0Gy)，分别。HD中值为17.0mm,13.9毫米和12.1毫米，分别。这些差异在体积上也很明显：PTV60的标准计划的体积范围为219.1-391.3cc（中位数：261.9cc），而实验计划的PTV75体积范围为71.5-142.7cc（中位数：92.3cc）。Dice评分偏差最大的结构是垂体（中位数0.37，范围0.00-0.69）和右泪腺（中位数0.59，范围0.42-0.78）。
■这些偏差表明，在放射肿瘤学临床试验开始之前，必须进行系统的培训，并进行适当的反馈，并不断监测方案的依从性，从而排除了研究。
■NCT05871021。
■选择了合适的患者病例，并进行了计算机断层扫描（CT），磁共振成像（MRI）和O-（2-[18F]氟乙基）-L-酪氨酸（FET）正电子发射断层扫描（PET）轮廓可用。各个预期研究地点的参与者根据PRIDE临床试验方案进行了辐射计划。治疗计划和剂量网格作为医学数字成像和通信（DICOM）文件上传到基于云的平台。使用标准化检查表分析计划质量和方案依从性，记分卡和指数，如骰子得分（DSC）和豪斯多夫距离（HD）。
■PTV60、PTV60ex的DSC中位数为0.89、0.90、0.88(标准和实验计划的计划目标体积为60.0Gy,分别)和PTV75(实验计划中PTV接收75.0Gy)，分别。HD中值为17.0mm,13.9毫米和12.1毫米，分别。这些差异在体积上也很明显：PTV60的标准计划的体积范围为219.1-391.3cc（中位数：261.9cc），而实验计划的PTV75体积范围为71.5-142.7cc（中位数：92.3cc）。Dice评分偏差最大的结构是垂体（中位数0.37，范围0.00-0.69）和右泪腺（中位数0.59，范围0.42-0.78）。
■这些偏差表明，在放射肿瘤学临床试验开始之前，必须进行系统的培训，并进行适当的反馈，并不断监测方案的依从性，从而排除了研究。
■NCT05871021。
