Maier Sebastian H, Schönecker Stephan, Anagnostatou Vasiliki, Garny Sylvia, Nitschmann Alexander, Fleischmann Daniel F, Büttner Marcel, Kaul David, Imhoff Detlef, Fokas Emmanouil, Seidel Clemens, Hau Peter, Kölbl Oliver, Popp Ilinca, Grosu Anca-Ligia, Haussmann Jan, Budach Wilfried, Celik Eren, Kahl Klaus-Henning, Hoffmann Elgin, Tabatabai Ghazaleh, Paulsen Frank, Holzgreve Adrien, Albert Nathalie L, Mansmann Ulrich, Corradini Stefanie, Belka Claus, Niyazi Maximilian, Bodensohn Raphael
Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.
Bavarian Cancer Research Center (BZKF), Munich, Germany.
Clin Transl Radiat Oncol. 2024 May 4;47:100790. doi: 10.1016/j.ctro.2024.100790. eCollection 2024 Jul.
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.
A suitable patient case was selected and the computed tomography (CT), magnetic resonance imaging (MRI) and O-(2-[F]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).
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).
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.
NCT05871021.
PRIDE试验（NOA - 28；ARO - 2024 - 01；AG - NRO - 06；NCT05871021）旨在确定与历史中位总生存期（OS）率相比，30次分割给予75.0 Gy的剂量递增是否能提高甲基鸟嘌呤甲基转移酶（MGMT）启动子未甲基化的胶质母细胞瘤患者的中位总生存期，同时通过添加贝伐单抗（BEV）使其与历史队列具有同等毒性。为确保所有研究中心的放疗计划符合方案要求，计划进行一次预演并评估计划质量。
选择一个合适的患者病例，并提供计算机断层扫描（CT）、磁共振成像（MRI）和O -（2 - [F]氟乙基）- L -酪氨酸（FET）正电子发射断层扫描（PET）轮廓。各个预期研究地点的参与者根据PRIDE临床试验方案进行放射治疗计划。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、记分卡和诸如骰子分数（DSC）和豪斯多夫距离（HD）等指标分析计划质量和方案依从性。
PTV60、PTV60ex（分别为标准计划和实验计划接受60.0 Gy的计划靶体积）和PTV75（实验计划中接受75.0 Gy的PTV）的中位DSC分别为0.89、0.90、0.88。中位HD值分别为17.0 mm、13.9 mm和12.1 mm。这些差异在体积上也很明显：标准计划的PTV60体积范围为219.1 - 391.3 cc（中位数：261.9 cc），而实验计划的PTV75体积范围为71.5 - 142.7 cc（中位数：92.3 cc）。骰子分数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前进行有适当反馈的系统培训以及在整个研究过程中持续监测方案依从性的必要性。
NCT05871021。
