The quality assurance process for the ARTSCAN head and neck study - a practical interactive approach for QA in 3DCRT and IMRT.
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.
Johansson
Karl-Axel
KA
Sahlgrenska University Hospital, Göteborg, Sweden. kasl-axel.johansson@vgregion.se
Nilsson
Per
P
Zackrisson
Björn
B
Ohlson
Birgitta
B
Kjellén
Elisabeth
E
Mercke
Claes
C
Alvarez-Fonseca
Mauricio
M
Billström
Anette
A
Björk-Eriksson
Thomas
T
Björ
Ove
O
Ekberg
Lars
L
Friesland
Signe
S
Karlsson
Magnus
M
Lagerlund
Magnus
M
Lundkvist
Lena
L
Löfroth
Per-Olov
PO
Löfvander-Thapper
Kerstin
K
Nilsson
Alla
A
Nyman
Jan
J
Persson
Essie
E
Reizenstein
Johan
J
Rosenbrand
Hans-Olov
HO
Wiklund
Fredrik
F
Wittgren
Lena
L
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