The European Society for Paediatric Oncology (SIOP Europe), Clos Chapelle-aux-Champs 30, Brussels, Belgium; European Organisation for the Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium; Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
The European Society for Paediatric Oncology (SIOP Europe), Clos Chapelle-aux-Champs 30, Brussels, Belgium; European Organisation for the Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium; Department of Oncology, University of Medicine and Pharmacy "Iuliu Hatieganu" Cluj-Napoca, Romania.
Radiother Oncol. 2023 May;182:109549. doi: 10.1016/j.radonc.2023.109549. Epub 2023 Feb 23.
SIOP Europe's QUARTET project launched in 2016; aiming to improve access to high-quality radiotherapy for children and adolescents treated within clinical trials across Europe. The aim of this report is to present the profile of institutions participating in six QUARTET-affiliated trials and a description of the initial individual case review (ICR) outcomes.
This is a two-part analysis. Firstly, using facility questionnaires, beam output audit certificates, and advanced technique credentialing records to create a profile of approved institutions, and secondly, collating trial records for ICRs submitted prior to 31/10/2022. Trials included are: SIOPEN HR-NBL1, SIOPEN-LINES, SIOPEN- VERITAS, SIOP-BTG HRMB, EpSSG-FaR-RMS, and SIOPEN HR-NBL2.
By 31/10/2022, a total of 103 institutions had commenced QUARTET site approval procedures to participate in QUARTET-affiliated trials; 66 sites across 20 countries were approved. These participating institutions were often paediatric referral sites with intensity modulated radiotherapy or proton beam therapy, designated paediatric radiation oncologists, and paediatric adapted facilities and imaging protocols available. In total, 263 patient plans were submitted for ICR, 254 ICRs from 15 countries were completed. ICRs had a rejection rate of 39.8%, taking an average of 1.4 submissions until approval was achieved. Target delineation was the most frequent reason for rejection.
The QUARTET facility questionnaire is a valuable tool for mapping resources, personnel, and technology available to children and adolescents receiving radiotherapy. Prospective ICR is essential for paediatric oncology clinical trials and should be prioritised to reduce protocol violations.
SIOP 欧洲的 QUARTET 项目于 2016 年启动；旨在改善欧洲临床试验中接受治疗的儿童和青少年获得高质量放疗的机会。本报告的目的是介绍参与六个 QUARTET 附属试验的机构概况，并描述初始个别病例审查（ICR）结果。
这是一个两部分的分析。首先，使用设施问卷、束流输出审核证书和先进技术认证记录创建已批准机构的概况，其次，整理 2022 年 10 月 31 日前提交的 ICR 试验记录。纳入的试验包括：SIOPEN HR-NBL1、SIOPEN-LINES、SIOPEN-VERITAS、SIOP-BTG HRMB、EpSSG-FaR-RMS 和 SIOPEN HR-NBL2。
截至 2022 年 10 月 31 日，共有 103 家机构已开始 QUARTET 站点批准程序，以参与 QUARTET 附属试验；来自 20 个国家的 66 个站点获得批准。这些参与机构通常是具有调强放疗或质子束治疗的儿科转诊机构，指定了儿科放射肿瘤学家，并且提供了儿科适应性设施和成像协议。共提交了 263 份患者计划进行 ICR，来自 15 个国家的 254 份 ICR 已完成。ICR 的拒绝率为 39.8%，平均需要提交 1.4 次才能获得批准。靶区勾画是拒绝的最常见原因。
QUARTET 设施问卷是一种用于绘制接受放疗的儿童和青少年可获得资源、人员和技术的有价值的工具。前瞻性 ICR 对于儿科肿瘤学临床试验至关重要，应优先考虑以减少方案违规。
