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.
OBJECTIVE
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.


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.
Haworth
Annette
A
Department of Physical Sciences, Peter MacCallum Cancer Centre, Melbourne, Australia. Annette.haworth@petermac.org
Kearvell
Rachel
R
Greer
Peter B
PB
Hooton
Ben
B
Denham
James W
JW
Lamb
David
D
Duchesne
Gillian
G
Murray
Judy
J
Joseph
David
D
D006801:Humans; D008297:Male; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal; D012107:Research Design