Quality assurance Assuring high quality treatment delivery in clinical trials – Results from the Trans-Tasman Radiation Oncology Group (TROG) study 03.04 ‘‘RADAR” set-up accuracy study Annette Haworth a, * , Rachel Kearvell b , Peter B. Greer c , Ben Hooton b , James W. Denham c , David Lamb d , Gillian Duchesne e , Judy Murray d , David Joseph b a Department of Physical Sciences, Peter MacCallum Cancer Centre, Melbourne, Australia b Department of Radiation Oncology, Sir Charles Gairdner Hospital, WA, Australia c Department of Radiation Oncology, University of Newcastle, Australia d Wellington Blood and Cancer Centre, Wellington Hospital, Wellington, New Zealand e Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia article info Article history: Received 29 February 2008 Received in revised form 24 August 2008 Accepted 4 October 2008 Available online 18 November 2008 Keywords: Quality assurance Clinical trials Set-up accuracy Prostate abstract Background and purpose: A multi-centre clinical trial for prostate cancer patients provided an opportunity to introduce conformal radiotherapy with dose escalation. To verify adequate treatment accuracy prior to patient recruitment, centres submitted details of a set-up accuracy study (SUAS). We report the results of the SUAS, the variation in clinical practice and the strategies used to help centres improve treatment accuracy. Materials and methods: The SUAS required each of the 24 participating centres to collect data on at least 10 pelvic patients imaged on a minimum of 20 occasions. Software was provided for data collection and analysis. Support to centres was provided through educational lectures, the trial quality assurance team and an information booklet. Results: Only two centres had recently carried out a SUAS prior to the trial opening. Systematic errors were generally smaller than those previously reported in the literature. The questionnaire identified many differences in patient set-up protocols. As a result of participating in this QA activity more than 65% of centres improved their treatment delivery accuracy. Conclusions: Conducting a pre-trial SUAS has led to improvement in treatment delivery accuracy in many centres. Treatment techniques and set-up accuracy varied greatly, demonstrating a need to ensure an on- going awareness for such studies in future trials and with the introduction of dose escalation or new technologies. Crown Copyright Ó 2008 Published by Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 90 (2009) 299–306 Clinical trials have the ability to change everyday clinical prac- tice, but in the case of trials allowing high radiation doses or the introduction of new technology, this opportunity will be lost un- less great care is given in ensuring that the radiation is delivered accurately to the intended location. Clinical trial quality assurance (QA) is therefore essential to ensure that the trial answers the question it sets out to achieve and furthermore, clinical trials pro- vide the opportunity to change the quality assurance culture with- in participating centres. The MRC RT01 trial was the first trial to demonstrate that through its radiographer led quality QA program, treatment set-up accuracy can be improved on a mass scale [1–3]. The MRC RT01 trial along with several others [4–7] indicate that in select groups of prostate cancer patients, dose escalation may be of benefit in terms of disease control but at a cost of some increase in rectal injury. It is therefore essential that any new trial must be de- signed so that any perceived benefits are not offset with unaccept- able levels of harm to the patient. The QA program must therefore address this issue but also take advantage of the opportunity to lead centres towards introducing a self-regulating quality assur- ance program for any new technique either within or outside the context of a clinical trial. In October 2003, the Trans-Tasman Radiation Oncology Group (TROG) opened clinical trial 03.04 or ‘‘RADAR”, which aims to determine the optimal duration of hormonal deprivation in addi- tion to radiation therapy in intermediate and high risk prostate cancer patients. The trial closed in August 2007 after recruiting 1066 patients from 24 centres. During this period, three-dimen- sional conformal radiotherapy (3DCRT) techniques were intro- 0167-8140/$ - see front matter Crown Copyright Ó 2008 Published by Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.radonc.2008.10.011 * Corresponding author. Address: Department of Physical Sciences, Peter Mac- Callum Cancer Centre, Locked Bag 1 A’Beckett St., Vic. 8006, Australia. E-mail address: Annette.haworth@petermac.org (A. Haworth). Radiotherapy and Oncology 90 (2009) 299–306 Contents lists available at ScienceDirect Radiotherapy and Oncology journal homepage: www.thegreenjournal.com