Toggle Main Menu Toggle Search

Open Access padlockePrints

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

Lookup NU author(s): Professor Simon BaileyORCiD

Downloads


Licence

This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2023 The Author(s)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.


Publication metadata

Author(s): Kelly SM, Turcas A, Corning C, Bailey S, Canete A, Clementel E, di Cataldo A, Dieckmann K, Gaze MN, Horan G, Jenney M, Ladenstein R, Padovani L, Valteau-Couanet D, Boterberg T, Mandeville H

Publication type: Article

Publication status: Published

Journal: Radiotherapy and Oncology

Year: 2023

Volume: 182

Print publication date: 01/05/2023

Online publication date: 23/02/2023

Acceptance date: 04/02/2023

Date deposited: 20/03/2023

ISSN (print): 0167-8140

ISSN (electronic): 1879-0887

Publisher: Elsevier Ireland Ltd

URL: https://doi.org/10.1016/j.radonc.2023.109549

DOI: 10.1016/j.radonc.2023.109549

PubMed id: 36828140


Altmetrics

Altmetrics provided by Altmetric


Share