Abstract

BackgroundThe ongoing EORTC 22042–26042 trial evaluates the efficacy of high-dose radiotherapy (RT) in atypical/malignant meningioma. The results of the Dummy Run (DR) and prospective Individual Case Review (ICR) were analyzed in this Quality Assurance (QA) study.Material/methodsInstitutions were requested to submit a protocol compliant treatment plan for the DR and ICR, respectively. DR-plans (n=12) and ICR-plans (n=50) were uploaded to the Image-Guided Therapy QA Center of Advanced Technology Consortium server (http://atc.wustl.edu/) and were assessed prospectively.ResultsMajor deviations were observed in 25% (n=3) of DR-plans while no minor deviations were observed. Major and minor deviations were observed in 22% (n=11) and 10% (n=5) of the ICR-plans, respectively. Eighteen% of ICRs could not be analyzed prospectively, as a result of corrupted or late data submission. CTV to PTV margins were respected in all cases. Deviations were negatively associated with the number of submitted cases per institution (p=0.0013), with a cutoff of 5 patients per institutions. No association (p=0.12) was observed between DR and ICR results, suggesting that DR’s results did not predict for an improved QA process in accrued brain tumor patients.ConclusionsA substantial number of protocol deviations were observed in this prospective QA study. The number of cases accrued per institution was a significant determinant for protocol deviation. These data suggest that successful DR is not a guarantee for protocol compliance for accrued patients. Prospective ICRs should be performed to prevent protocol deviations.

Highlights

  • The objective of the European Organization for the Research and Treatment of Cancer (EORTC) 22042–26042 (NCT00626730) open study is to assess the impact of high-dose radiotherapy (RT) on progression-free survival, treatment tolerance and post-treatment global cognitive functioning in patients with a diagnosis of either atypical (World Health Organization [WHO] grade II) or malignant (WHO grade III) meningioma

  • Clinical Target Volume (CTV) to Planned Treatment Volume (PTV) margins were respected in all cases

  • A substantial number of protocol deviations were observed in this prospective Quality Assurance (QA) study

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Summary

Introduction

The objective of the European Organization for the Research and Treatment of Cancer (EORTC) 22042–26042 (NCT00626730) open study is to assess the impact of high-dose radiotherapy (RT) on progression-free survival, treatment tolerance and post-treatment global cognitive functioning in patients with a diagnosis of either atypical (World Health Organization [WHO] grade II) or malignant (WHO grade III) meningioma. QA is of paramount importance when delivering high dose radiation to the brain in the context of a clinical trial. We report the results of the QA analysis of the first fully digital and prospective Individual Case Review (ICR) conducted in an international multicenter clinical trial for brain tumor. The ongoing EORTC 22042–26042 trial evaluates the efficacy of high-dose radiotherapy (RT) in atypical/malignant meningioma. The results of the Dummy Run (DR) and prospective Individual Case Review (ICR) were analyzed in this Quality Assurance (QA) study. DR-plans (n=12) and ICR-plans (n=50) were uploaded to the Image-Guided Therapy QA Center of Advanced Technology Consortium server (http://atc.wustl.edu/) and were assessed prospectively

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