André N Abrunhosa-Branquinho1, Raquel Bar-Deroma2, Sandra Collette3, Enrico Clementel3, Yan Liu3, Coen W Hurkmans4, Loïc Feuvret5, Karen Van Beek6, Martin van den Bent7, Brigitta G Baumert8, Damien C Weber9. 1. EORTC HQ, Brussels, Belgium; Radiotherapy Department, Hospital de Santa Maria - Centro Hospitalar Lisboa Norte, EPE, Portugal. Electronic address: andre.branquinho@chln.min-saude.pt. 2. Radiation Oncology, Rambam Health Care Campus, Haifa, Israel. 3. EORTC HQ, Brussels, Belgium. 4. ROG RTQA Strategic Committee, EORTC, Brussels, Belgium; Department of Radiation Oncology, Catharina Hospital, Eindhoven, The Netherlands. 5. Service de Radiothérapie, Hôpital de la Pitié-Salpêtrière, Paris, France. 6. Department of Radiation Oncology, University Hospital Leuven, Belgium. 7. Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. 8. Maastricht University Medical Centre and GROW (School for Oncology and Developmental Biology), Maastricht, Netherlands; Dept. of Radiation Oncology, Paracelsus Clinic, Osnabrück & Dept. of Radiation Oncology, University of Müenster, Germany. 9. Center for Proton Therapy, Paul Scherrer Institute, ETH Domain, Villigen, Switzerland; University Hospital of Zürich, Switzerland.
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.
RCT Entities:
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.
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