title: Quality assurance in the EORTC 22033-26033/CE5 phase III randomized trial for low grade glioma: the digital individual case review.
abstract: BACKGROUND
  The phase III EORTC 22033-26033/NCIC CE5 intergroup trial compares 50.4 Gy radiotherapy with up-front temozolomide in previously untreated low-grade glioma. We describe the digital EORTC individual case review (ICR) performed to evaluate protocol radiotherapy (RT) compliance.
  
  
  METHODS
  Fifty-eight institutions were asked to submit 1-2 randomly selected cases. Digital ICR datasets were uploaded to the EORTC server and accessed by three central reviewers. Twenty-seven parameters were analysed including volume delineation, treatment planning, organ at risk (OAR) dosimetry and verification. Consensus reviews were collated and summary statistics calculated.
  
  
  RESULTS
  Fifty-seven of seventy-two requested datasets from forty-eight institutions were technically usable. 31/57 received a major deviation for at least one section. Relocation accuracy was according to protocol in 45. Just over 30% had acceptable target volumes. OAR contours were missing in an average of 25% of cases. Up to one-third of those present were incorrectly drawn while dosimetry was largely protocol compliant. Beam energy was acceptable in 97% and 48 patients had per protocol beam arrangements.
  
  
  CONCLUSIONS
  Digital RT plan submission and review within the EORTC 22033-26033 ICR provide a solid foundation for future quality assurance procedures. Strict evaluation resulted in overall grades of minor and major deviation for 37% and 32%, respectively.
authors.affiliation: EORTC Headquarters, Brussels, Belgium. alysa@ualberta.ca
authors.forename: Alysa
authors.initials: A
authors.lastname: Fairchild
authors.forename: Damien C
authors.initials: DC
authors.lastname: Weber
authors.forename: Raquel
authors.initials: R
authors.lastname: Bar-Deroma
authors.forename: Akos
authors.initials: A
authors.lastname: Gulyban
authors.forename: Paul A
authors.initials: PA
authors.lastname: Fenton
authors.forename: Roger
authors.initials: R
authors.lastname: Stupp
authors.forename: Brigitta G
authors.initials: BG
authors.lastname: Baumert
mesh_terms: D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use; D001932:Brain Neoplasms / Q000188:drug therapy / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000031:analogs & derivatives / Q000627:therapeutic use; D057286:Electronic Health Records / Q000592:standards*; D005910:Glioma / Q000188:drug therapy / Q000532:radiotherapy*; D006801:Humans; D011785:Quality Assurance, Health Care; D011879:Radiotherapy Dosage; D000077204:Temozolomide
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide