PRIDE 试验（NOA-28；ARO-2024-01；AG-NRO-06）中使用的用于胶质母细胞瘤等毒性剂量递增放射治疗计划的模拟运行

IF 2.7 3区医学 Q3 ONCOLOGY

Clinical and Translational Radiation Oncology Pub Date : 2024-05-04 DOI:10.1016/j.ctro.2024.100790

Sebastian H. Maier , Stephan Schönecker , Vasiliki Anagnostatou , Sylvia Garny , Alexander Nitschmann , Daniel F. Fleischmann , Marcel Büttner , David Kaul , Detlef Imhoff , Emmanouil Fokas , Clemens Seidel , Peter Hau , Oliver Kölbl , Ilinca Popp , Anca-Ligia Grosu , Jan Haussmann , Wilfried Budach , Eren Celik , Klaus-Henning Kahl , Elgin Hoffmann , Raphael Bodensohn

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引用次数: 0

摘要

背景PRIDE试验（NOA-28；ARO-2024-01；AG-NRO-06；NCT05871021）旨在确定与历史中位OS率相比，剂量升级为75.0 Gy，分30次照射是否能提高甲基鸟嘌呤甲基转移酶（MGMT）启动子未甲基化胶质母细胞瘤患者的中位总生存率（OS），同时通过同时加用贝伐单抗（BEV）与历史队列同毒性。方法选择合适的患者病例，并提供计算机断层扫描（CT）、磁共振成像（MRI）和O-(2-[18F]氟乙基)-L-酪氨酸（FET）正电子发射断层扫描（PET）轮廓图。各预定研究地点的参与者根据 PRIDE 临床试验方案执行放射计划。治疗计划和剂量网格作为医学数字成像和通信 (DICOM) 文件上传到云平台。结果PTV60、PTV60ex（标准计划和实验计划的计划靶体积分别为60.0 Gy）和PTV75（实验计划的PTV为75.0 Gy）的中位数DSC分别为0.89、0.90和0.88。HD 中值分别为 17.0 毫米、13.9 毫米和 12.1 毫米。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 毫升（中值：261.9 毫升），而实验计划的 PTV75 体积范围为 71.5-142.7 毫升（中值：92.3 毫升）。Dice评分偏差最大的结构是垂体（中位数为0.37，范围为0.00-0.69）和右泪腺（中位数为0.59，范围为0.42-0.78）。

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Dummy run for planning of isotoxic dose-escalated radiation therapy for glioblastoma used in the PRIDE trial (NOA-28; ARO-2024-01; AG-NRO-06)

Background

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.

Methods

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).

Results

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).

Conclusions

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.