title: Quality assurance of the EORTC 22043-30041 trial in post-operative radiotherapy in prostate cancer: results of the Dummy Run procedure.
abstract: OBJECTIVE
  The EORTC 22043-30041 trial investigates the role of the addition of androgen suppression to post-operative radiotherapy in patients who have undergone radical prostatectomy. As part of the quality assurance of radiotherapy (QART) a Dummy Run (DR) procedure was performed.
  
  
  METHODS
  The protocol included detailed and published delineation guidelines. Participating institutions digitally submitted radiotherapy treatment volumes and a treatment plan for a standard clinical case. Submissions were centrally reviewed using the VODCA software platform.
  
  
  RESULTS
  Thirty-eight submissions from thirty-one institutions were reviewed. Six were accepted without comments. Twenty-three were accepted with comments on one or more items: target volume delineation (22), OAR delineation (23), planning and dosimetry (3) or treatment verification (1). Nine submissions were rejected requiring resubmission, seven for target volume delineation reasons alone. Intervention to highlight the importance of delineation guidelines was made prior to the entry of the first patient in the trial. After this, a lower percentage of resubmissions was required.
  
  
  CONCLUSIONS
  The EORTC 22043-30041 Dummy Run highlights the need for timely and effective QART in clinical trials. The variation in target volume and OAR definition demonstrates that clinical guidelines and radiotherapy protocols are not a substitute for QART procedures. Early intervention in response to the Dummy Run improved protocol understanding.
authors.affiliation: EORTC Headquarters, Brussels, Belgium. pafenton@doctors.net.uk
authors.forename: Paul A
authors.initials: PA
authors.lastname: Fenton
authors.forename: Coen
authors.initials: C
authors.lastname: Hurkmans
authors.forename: Akos
authors.initials: A
authors.lastname: Gulyban
authors.forename: Jorien
authors.initials: J
authors.lastname: van der Leer
authors.forename: Oscar
authors.initials: O
authors.lastname: Matzinger
authors.forename: Philip
authors.initials: P
authors.lastname: Poortmans
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.forename: Michel
authors.initials: M
authors.lastname: Bolla
mesh_terms: D006801:Humans; D008297:Male; D058958:Organs at Risk; D017410:Practice Guidelines as Topic; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D047368:Tumor Burden
keywords: Delineation; Dummy Run; Prostate; Quality assurance; Radiotherapy