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Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials

Kelly, SM; Turcas, A; Corning, C; Bailey, S; Cañete, A; Clementel, E; di Cataldo, A; ... Mandeville, H; + view all (2023) Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials. Radiotherapy and Oncology , 182 , Article 109549. 10.1016/j.radonc.2023.109549. Green open access

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Abstract

Background and Purpose: 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. Methods: 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. Results: 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. Conclusion: 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.

Type: Article
Title: Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials
Location: Ireland
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.radonc.2023.109549
Publisher version: https://doi.org/10.1016/j.radonc.2023.109549
Language: English
Additional information: ©2023 The Author(s). Published by Elsevier B.V. Radiotherapy and Oncology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Clinical Trial, Pediatrics, Quality Assurance, Health Care, Quality Control, Radiation Oncology, Radiotherapy, Adolescent, Child, Humans, Prospective Studies, Quality Assurance, Health Care, Radiation Oncology, Radiotherapy Planning, Computer-Assisted, Radiotherapy, Intensity-Modulated
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Oncology
URI: https://discovery.ucl.ac.uk/id/eprint/10182202
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