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Clinical Trial
. 2018 May;127(2):292-298.
doi: 10.1016/j.radonc.2018.03.013. Epub 2018 Mar 29.

Radiotherapy quality assurance for the RTOG 0834/EORTC 26053-22054/NCIC CTG CEC.1/CATNON intergroup trial "concurrent and adjuvant temozolomide chemotherapy in newly diagnosed non-1p/19q deleted anaplastic glioma": Individual case review analysis

André N Abrunhosa-Branquinho  1 , Raquel Bar-Deroma  2 , Sandra Collette  3 , Enrico Clementel  3 , Yan Liu  3 , Coen W Hurkmans  4 , Loïc Feuvret  5 , Karen Van Beek  6 , Martin van den Bent  7 , Brigitta G Baumert  8 , Damien C Weber  9
Affiliations
Clinical Trial

Radiotherapy quality assurance for the RTOG 0834/EORTC 26053-22054/NCIC CTG CEC.1/CATNON intergroup trial "concurrent and adjuvant temozolomide chemotherapy in newly diagnosed non-1p/19q deleted anaplastic glioma": Individual case review analysis

André N Abrunhosa-Branquinho et al. Radiother Oncol. 2018 May.

Abstract

Background: The EORTC phase III 26053-22054/ RTOG 0834/NCIC CTG CEC.1/CATNON intergroup trial was designed to evaluate the impact on concurrent and adjuvant temozolomide chemotherapy in newly diagnosed non-1p/19q deleted anaplastic gliomas. The primary endpoint was overall survival. We report the results of retrospective individual case reviews (ICRs) for the first patient randomized per institution to detect the compliance with the study protocol.

Material and methods: Sixty-nine institutions were required to submit the radiotherapy plan of their first randomized patient. Full digital datasets uploaded to the EORTC server were assessed by three independent and blinded reviewers through the EORTC radiotherapy quality assurance platform.

Results: Sixty-two (90%) of sixty-nine ICRs were received and assessable. Of the 62 cases, 22 were evaluated as per protocol (35.5%), 11 as acceptable variation (17.7%) and 29 were classified as unacceptable variations (46.8%). Most common unacceptable variations were related to the PTV dose (n = 19, 31%) and delineation (n = 17, 27%) processes.

Conclusions: The ICR analysis showed a significant number of unacceptable variations with potential impact on tumor control and/or toxicity profile. Prospective ICRs are encouraged for future studies to prevent and correct protocol violations before start of treatment.

Keywords: Anaplastic glioma; EORTC; Individual case review; Phase III trial; RTQA; Radiotherapy.

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Conflict of interest statement

Conflicts of Interest Notification:

Martin van den Bent has received honoraria from Merck Sharp & Dohme Corp. The author & remaining co-authors have no potential Conflict of Interest.

Figures

Fig. 1.
Fig. 1.
Consensus grading for each subsections and overall
Fig. 2.
Fig. 2.
Examples of unacceptable cases observed during review. Case A is an unacceptable volume (target and organ at risk) definition case, in which displays incorrect delineation of the brainstem (brown), PTV (red) is not based on CTV (target volume not found) and GTV (green) does not involve all hypodense areas in the CT scan. Case B is an unacceptable case for PTV Dose, in which the PTV (marked in red) is undercovered by the isodose lines 95% (yellow) and 90% (blue), and histogram shows PTV D95=86%. Case C is an unacceptable case for dose in OARs, in which displays a Dmax=61.62 Gy for brain stem.
See this image and copyright information in PMC

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