During the 1980s work on QA RT (quality assurance in radiotherapy) studies was taken up by Emmanuel van der Schueren in close collaboration between ESTRO (European Society for Therapeutic Radiology and Oncology) and EORTC. He initiated work to improve the quality of radiotherapy delivery not only for patients included in clinical trials but also for patients routinely treated outside any clinical trial.
The last 30 years have seen major milestones in the development of QA RT at the EORTC, and now the EORTC has a QA RT Manager working full time at HQ alongside the Emmanuel van der Schueren Fellow for Quality Assurance in Radiotherapy. Since 2001 successive fellows have produced 36 papers and abstracts, in which it has been shown that rigorous application of QA measures before and during radiotherapy studies improves the treatment and as a direct consequence the outcome for patients in clinical studies.
1982: Start QA program
1986: Start of an External Dosimetry program
1989: Development of the Facility Questionnaire
1993-1996: External Dosimetry Audit program across Europe
1999: Start of Emmanuel van der Schueren QART Fellowship program (sponsored by VLK)
2004: ROG-QART committee was formally established
2006: Standardized approach of QART (definition of different levels)
2008: Full time QART manager appointed
2009: Acquiring VODCA for central QART platform
In 2009 the EORTC Board and Executive Committee have recognized the importance that dedicated and effective QA RT has in ensuring the standard and consistency of RT throughout the broad spectrum of the EORTC clinical trial portfolio and in maintaining the quality and interpretability of the data on which the clinical trial outcomes depend. They have therefore decided to implement QA RT across all activities at the EORTC which involve RT in a prospective and standardized manner through the Radiation Oncology Group (ROG).
The QA RT process of the ROG
The ROG has restructured its QA RT Team to facilitate QA RT input at the earliest points in trial development. A rapid strategic assessment of the need and extent of QA RT will be made when the concept of any trial which involves RT is being developed, followed by further input from dedicated QA RT experts for the specific tumor site during the process of protocol development.
A dedicated clinician and physicist will be allocated to each new study involving RT. Their responsibilities will be to collaborate with the PI in drafting the radiotherapy protocol text, to design the QA measures, and to perform their evaluation (dummy run, individual case review, etc.). The overall aim of this new approach is to ensure early definition of the QA measures needed in any new study, to allocate dedicated independent personnel to its execution, and to ensure valid results from all studies.
Rules for the development of radiotherapy protocols have been drawn up indicating the tasks and responsibilities of all concerned.
The ROG has defined 5 levels of QA, whose application depends on the complexity of the protocol. The defined levels are not mutually exclusive, they are complimentary, and an acceptable QART program may contain multiple levels depending on the therapeutic question involved.
- Baseline (for all participating/treating centers): online completion of the Facility Questionnaire (FQ) and the provision of the most recent (no older than 2 years) External Reference Dosimetry Audit (ERDA) results.
- Dummy Run/Dry Run (DR): a test of the treatment planning using a fictitious patient; in most cases this is carried out prior to the start of patient entry, allowing any corrections to the planning process or protocol to be made as early as possible in the study.
- Limited Individual Case Review (ICR): review of a limited number of patient (RT) treatment files (including target volumes and organ at risk delineation, isodose distribution, monitor units, etc.) which is ideally carried out early in the accrual phase so that possible deviations can be rectified for future patients.
- Extended Individual Case Review: identical to the limited individual case review procedures, but the majority (or all) patient treatment charts are reviewed.
- Complex Dosimetry Check: advanced QA measures designed to address the increasing use of complex advanced 3D conformal, intensity-modulated, and image guided RT techniques.
Impact and implications for the EORTC
Individual investigators and institutions can have confidence in a clear and standardized approach to QA RT across all EORTC activities which will support and enhance their efforts to deliver high-quality RT to patients both within and outside clinical trials. The new ROG QART structure will facilitate prospective incorporation of advanced RT techniques and allow any unforeseen issues to be addressed in an expedient and consistent manner.
EORTC Groups will benefit from QA RT support at all stages in the trial process, promoting interdisciplinary interaction and making the optimal use of expertise and resources. Transparent, structured, independent and consistent QA RT assessments and procedures will enhance the quality of RT in clinical trials and the reliability and consistency of RT will ensure and enhance the relevance and applicability of the clinical trial results.
As an organization the EORTC will benefit from ongoing improvements in the quality and consistency of RT in its clinical trials. The clear, consistent and progressive approach to QA RT will promote the goals of EORTC on the international stage and allow the organization to build international standards for quality assurance in clinical trials. The pursuit of high quality treatment within EORTC clinical trials will continue to improve the care of all patients with cancer.
Vincent Gregoire, Cliniques Universitaires St. Luc, Brussels, Belgium, on behalf of the EORTC Radiation Oncology Group