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

J 2023

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

KELLY, Sarah M; Andrada TURCAS; Coreen CORNING; Simon BAILEY; Adela CANETE et al.

Základní údaje

Originální název

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

Autoři

Vydání

RADIOTHERAPY AND ONCOLOGY, NETHERLANDS, ELSEVIER IRELAND LTD, 2023, 0167-8140

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30230 Other clinical medicine subjects

Stát vydavatele

Nizozemské království

Utajení

není předmětem státního či obchodního tajemství

Odkazy

FaR-RMS + SIOP-HRMB

Impakt faktor

Impact factor: 4.900

Kód RIV

RIV/00216224:90249/23:00138212

Organizační jednotka

CZECRIN IV

DOI

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

UT WoS

000991959700001

EID Scopus

2-s2.0-85149230827

Klíčová slova česky

Radiotherapy; Radiation Oncology; Pediatrics; Clinical Trial; Quality Control; Quality Assurance; Health Care

Klíčová slova anglicky

Radiotherapy; Radiation Oncology; Pediatrics; Clinical Trial; Quality Control; Quality Assurance; Health Care

Štítky

CZECRIN, Excelence Science, RIV, user, článek v časopise

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 4. 4. 2025 13:18, Mgr. Tereza Miškechová

Anotace

V originále

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 proto-cols available. In total, 263 patient plans were submitted for ICR, 254 ICRs from 15 countries were com-pleted. 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.(c) 2023 The Author(s). Published by Elsevier B.V. Radiotherapy and Oncology 182 (2023) 1-8

Návaznosti

90249, velká výzkumná infrastruktura

Název: CZECRIN IV

Citovat

KELLY, Sarah M; Andrada TURCAS; Coreen CORNING; Simon BAILEY; Adela CANETE; Enrico CLEMENTEL; di Cataldo ANDREA; Karin DIECKMANN; Mark N GAZE; Gail HORAN; Meriel JENNEY; Ruth LADENSTEIN; Laetitia PADOVANI; Dominique VALTEAU-COUANET; Tom BOTERBERG a Henry MANDEVILLE. Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials. RADIOTHERAPY AND ONCOLOGY. NETHERLANDS: ELSEVIER IRELAND LTD, 2023, roč. 182, č. 2023, s. 1-8. ISSN 0167-8140. Dostupné z: https://doi.org/10.1016/j.radonc.2023.109549.

@article{2464270,
   author = {Kelly, Sarah M and Turcas, Andrada and Corning, Coreen and Bailey, Simon and Canete, Adela and Clementel, Enrico and Andrea, di Cataldo and Dieckmann, Karin and Gaze, Mark N and Horan, Gail and Jenney, Meriel and Ladenstein, Ruth and Padovani, Laetitia and ValteauandCouanet, Dominique and Boterberg, Tom and Mandeville, Henry},
   article_location = {NETHERLANDS},
   article_number = {2023},
   doi = {https://doi.org/10.1016/j.radonc.2023.109549},
   keywords = {Radiotherapy; Radiation Oncology; Pediatrics; Clinical Trial; Quality Control; Quality Assurance; Health Care},
   language = {eng},
   issn = {0167-8140},
   journal = {RADIOTHERAPY AND ONCOLOGY},
   title = {Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials},
   url = {https://www.webofscience.com/wos/woscc/full-record/WOS:000991959700001},
   volume = {182},
   year = {2023}
}

TY  - JOUR
ID  - 2464270
AU  - Kelly, Sarah M - Turcas, Andrada - Corning, Coreen - Bailey, Simon - Canete, Adela - Clementel, Enrico - Andrea, di Cataldo - Dieckmann, Karin - Gaze, Mark N - Horan, Gail - Jenney, Meriel - Ladenstein, Ruth - Padovani, Laetitia - Valteau-Couanet, Dominique - Boterberg, Tom - Mandeville, Henry
PY  - 2023
TI  - Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials
JF  - RADIOTHERAPY AND ONCOLOGY
VL  - 182
IS  - 2023
SP  - 1-8
EP  - 1-8
PB  - ELSEVIER IRELAND LTD
SN  - 01678140
KW  - Radiotherapy
KW  - Radiation Oncology
KW  - Pediatrics
KW  - Clinical Trial
KW  - Quality Control
KW  - Quality Assurance
KW  - Health Care
UR  - https://www.webofscience.com/wos/woscc/full-record/WOS:000991959700001
N2  - 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 proto-cols available. In total, 263 patient plans were submitted for ICR, 254 ICRs from 15 countries were com-pleted. 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.(c) 2023 The Author(s). Published by Elsevier B.V. Radiotherapy and Oncology 182 (2023) 1-8
ER  -

KELLY, Sarah M; Andrada TURCAS; Coreen CORNING; Simon BAILEY; Adela CANETE; Enrico CLEMENTEL; di Cataldo ANDREA; Karin DIECKMANN; Mark N GAZE; Gail HORAN; Meriel JENNEY; Ruth LADENSTEIN; Laetitia PADOVANI; Dominique VALTEAU-COUANET; Tom BOTERBERG a Henry MANDEVILLE. Radiotherapy quality assurance in paediatric clinical trials: first report from six QUARTET-affiliated trials. \textit{RADIOTHERAPY AND ONCOLOGY}. NETHERLANDS: ELSEVIER IRELAND LTD, 2023, roč.~182, č.~2023, s.~1-8. ISSN~0167-8140. Dostupné z: https://doi.org/10.1016/j.radonc.2023.109549.

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