TY - JOUR
T1 - 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”
T2 - Individual case review analysis
AU - Abrunhosa-Branquinho, André N.
AU - Bar-Deroma, Raquel
AU - Collette, Sandra
AU - Clementel, Enrico
AU - Liu, Yan
AU - Hurkmans, Coen W.
AU - Feuvret, Loïc
AU - Van Beek, Karen
AU - van den Bent, Martin
AU - Baumert, Brigitta G.
AU - Weber, Damien C.
N1 - Publisher Copyright:
© 2018 Elsevier B.V.
PY - 2018/5
Y1 - 2018/5
N2 - 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.
AB - 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.
KW - Anaplastic glioma
KW - EORTC
KW - Individual case review
KW - Phase III trial
KW - RTQA
KW - Radiotherapy
UR - http://www.scopus.com/inward/record.url?scp=85044512589&partnerID=8YFLogxK
U2 - 10.1016/j.radonc.2018.03.013
DO - 10.1016/j.radonc.2018.03.013
M3 - Article
C2 - 29606522
AN - SCOPUS:85044512589
SN - 0167-8140
VL - 127
SP - 292
EP - 298
JO - Radiotherapy and Oncology
JF - Radiotherapy and Oncology
IS - 2
ER -
