title: Quality assurance in the 22991 EORTC ROG trial in localized prostate cancer: dummy run and individual case review.
abstract: BACKGROUND
  EORTC trial 22991 was designed to evaluate the addition of concomitant and adjuvant short-term hormonal treatments to curative radiotherapy in terms of disease-free survival for patients with intermediate risk localized prostate cancer. In order to assess the compliance to the 3D conformal radiotherapy protocol guidelines, all participating centres were requested to participate in a dummy run procedure. An individual case review was performed for the largest recruiting centres as well.
  
  
  METHODS
  CT-data of an eligible prostate cancer patient were sent to 30 centres including a description of the clinical case. The investigator was requested to delineate the volumes of interest and to perform treatment planning according to the protocol. Thereafter, the investigators of the 12 most actively recruiting centres were requested to provide data on five randomly selected patients for an individual case review.
  
  
  RESULTS
  Volume delineation varied significantly between investigators. Dose constraints for organs at risk (rectum, bladder, hips) were difficult to meet. In the individual case review, no major protocol deviations were observed, but a number of dose reporting problems were documented for centres using IMRT.
  
  
  CONCLUSIONS
  Overall, results of this quality assurance program were satisfactory. The efficacy of the combination of a dummy run procedure with an individual case review is confirmed in this study, as none of the evaluated patient files harboured a major protocol deviation. Quality assurance remains a very important tool in radiotherapy to increase the reliability of the trial results. Special attention should be given when designing quality assurance programs for more complex irradiation techniques.
authors.affiliation: EORTC Headquarters, Belgium. Oscar.Matzinger@eortc.be
authors.forename: Oscar
authors.initials: O
authors.lastname: Matzinger
authors.forename: Philip
authors.initials: P
authors.lastname: Poortmans
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Giraud
authors.forename: Philippe
authors.initials: P
authors.lastname: Maingon
authors.forename: Tom
authors.initials: T
authors.lastname: Budiharto
authors.forename: Alfons C M
authors.initials: AC
authors.lastname: van den Bergh
authors.forename: J Bernard
authors.initials: JB
authors.lastname: Davis
authors.forename: Elena
authors.initials: E
authors.lastname: Musat
authors.forename: Fatma
authors.initials: F
authors.lastname: Ataman
authors.forename: Dominique P
authors.initials: DP
authors.lastname: Huyskens
authors.forename: Akos
authors.initials: A
authors.lastname: Gulyban
authors.forename: Michel
authors.initials: M
authors.lastname: Bolla
mesh_terms: D000726:Androgen Antagonists / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000188:drug therapy / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal; D050397:Radiotherapy, Intensity-Modulated; D012107:Research Design
chemical_list: D000726:Androgen Antagonists