A priori quality assurance using a benchmark case of the randomized phase 2 GORTEC 2014-14 in oligometastatic head and neck cancer patients.
Assurance qualité
Benchmark case
Cancer
Clinical trial
Deviation
Déviation
Essai clinique
Head and neck
ORL
Quality assurance
Radiothérapie stéréotaxique
Stereotactic radiotherapy
Journal
Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique
ISSN: 1769-6658
Titre abrégé: Cancer Radiother
Pays: France
ID NLM: 9711272
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
received:
16
02
2021
revised:
19
04
2021
accepted:
28
04
2021
pubmed:
28
9
2021
medline:
15
12
2021
entrez:
27
9
2021
Statut:
ppublish
Résumé
A Benchmark Case (BC) was performed as part of the quality assurance process of the randomized phase 2 GORTEC 2014-14 OMET study, testing the possibility of multisite stereotactic radiation therapy (SBRT) alone in oligometastatic head and neck squamous cell carcinoma (HNSCC) as an alternative to systemic treatment and SBRT. Compliance of the investigating centers with the prescription, delineation, planning and evaluation recommendations available in the research protocol was assessed. In addition, classical dosimetric analysis was supplemented by quantitative geometric analysis using conformation indices. Twenty centers participated in the BC analysis. Among them, four major deviations (MaD) were reported in two centers. Two (10%) centers in MaD had omitted the satellite tumor nodule and secondarily validated after revision. Their respective DICE indexes were 0.37 and 0 and use of extracranial SBRT devices suboptimal There were significant residual heterogeneities between participating centers, including those with a similar SBRT equipment, with impact of plan quality using standard indicators and geometric indices. A priori QA using a BC conditioning the participation of the clinical investigation centers showed deviations from good SBRT practice and led to the exclusion of one out of the twenty participating centers. The majority of centers have demonstrated rigorous compliance with the research protocol. The use of quality indexes adds a complementary approach to improve assessment of plan quality.
Identifiants
pubmed: 34565664
pii: S1278-3218(21)00076-7
doi: 10.1016/j.canrad.2021.04.005
pii:
doi:
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
755-762Informations de copyright
Copyright © 2021 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.