title: The quality assurance process for the ARTSCAN head and neck study - a practical interactive approach for QA in 3DCRT and IMRT.
abstract: OBJECTIVE
  This paper describes the quality assurance (QA) work performed in the Swedish multicenter ARTSCAN (Accelerated RadioTherapy of Squamous cell CArcinomas in the head and Neck) trial to guarantee high quality in a multicenter study which involved modern radiotherapy such as 3DCRT or IMRT.
  
  
  METHODS
  The study was closed in June 2006 with 750 randomised patients. Radiation therapy-related data for every patient were sent by each participating centre to the QA office where all trial data were reviewed, analysed and stored. In case of any deviation from the protocol, an interactive process was started between the QA office and the local responsible clinician and/or physicist to increase the compliance to the protocol for future randomised patients. Meetings and workshops were held on a regular basis for discussions on various trial-related issues and for the QA office to report on updated results.
  
  
  CONCLUSIONS
  This review covers the 734 patients out of a total of 750 who had entered the study. Deviations early in the study were corrected so that the overall compliance to the protocol was very high. There were only negligible variations in doses and dose distributions to target volumes for each specific site and stage. The quality of the treatments was high. Furthermore, an extensive database of treatment parameters was accumulated for future dose-volume vs. endpoint evaluations.
  
  
  CONCLUSIONS
  This comprehensive QA programme increased the probability to draw firm conclusions from our study and may serve as a concept for QA work in future radiotherapy trials where comparatively small effects are searched for in a heterogeneous tumour population.
authors.affiliation: Sahlgrenska University Hospital, Göteborg, Sweden. kasl-axel.johansson@vgregion.se
authors.forename: Karl-Axel
authors.initials: KA
authors.lastname: Johansson
authors.forename: Per
authors.initials: P
authors.lastname: Nilsson
authors.forename: Björn
authors.initials: B
authors.lastname: Zackrisson
authors.forename: Birgitta
authors.initials: B
authors.lastname: Ohlson
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Kjellén
authors.forename: Claes
authors.initials: C
authors.lastname: Mercke
authors.forename: Mauricio
authors.initials: M
authors.lastname: Alvarez-Fonseca
authors.forename: Anette
authors.initials: A
authors.lastname: Billström
authors.forename: Thomas
authors.initials: T
authors.lastname: Björk-Eriksson
authors.forename: Ove
authors.initials: O
authors.lastname: Björ
authors.forename: Lars
authors.initials: L
authors.lastname: Ekberg
authors.forename: Signe
authors.initials: S
authors.lastname: Friesland
authors.forename: Magnus
authors.initials: M
authors.lastname: Karlsson
authors.forename: Magnus
authors.initials: M
authors.lastname: Lagerlund
authors.forename: Lena
authors.initials: L
authors.lastname: Lundkvist
authors.forename: Per-Olov
authors.initials: PO
authors.lastname: Löfroth
authors.forename: Kerstin
authors.initials: K
authors.lastname: Löfvander-Thapper
authors.forename: Alla
authors.initials: A
authors.lastname: Nilsson
authors.forename: Jan
authors.initials: J
authors.lastname: Nyman
authors.forename: Essie
authors.initials: E
authors.lastname: Persson
authors.forename: Johan
authors.initials: J
authors.lastname: Reizenstein
authors.forename: Hans-Olov
authors.initials: HO
authors.lastname: Rosenbrand
authors.forename: Fredrik
authors.initials: F
authors.lastname: Wiklund
authors.forename: Lena
authors.initials: L
authors.lastname: Wittgren
mesh_terms: D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D011785:Quality Assurance, Health Care; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000592:standards*; D050397:Radiotherapy, Intensity-Modulated / Q000592:standards*; D013548:Sweden; D016896:Treatment Outcome