Published evidence over the past years has stressed the need for dedicated QA programs in Radiation Therapy in general and RT Trials in particular. The EORTC Radiation Oncology Group (ROG) has been implementing Radiation Therapy Quality Assurance (RTQA) procedures in clinical trials since 1982. This valuable experience has made RTQA indispensable to all EORTC trials with Radiation Therapy and has also led to more than 40 publications. View here the RTQA structure.
From referral to treatment, the patient pathway is fraught with sources of variation. RTQA procedures at EORTC are structured to cover these sources as widely as possible and are tailored to suit each trial needs to achieve quality in the most efficient way. To ensure this, the RTQA office is involved through all steps of the study life cycle:
The following is a brief introduction to the RTQA procedures that prospective sites in a clinical trial must fulfill in order to ensure protocol compliancy.
Facility Questionnaire and Beam Output Audit
This procedure covers sources of variation at infrastructural and personnel level. The radiotherapy department concerned must complete the EORTC ROG Facility Questionnaire (FQ) giving details of their equipment, procedures and personnel available. This questionnaire can be found here. The FQ requests information on equipment and staffing of the radiotherapy facility and needs to be updated as soon as new equipment is installed and/or when there are major changes in staffing. There is also a PDF version of the questionnaire which can be printed and used to collect the necessary information for submission on-line. Please find here a list of currently validated sites.
All EORTC centres entering patients in studies where radiotherapy is part of protocol treatment are also required to submit their most recent results of a Beam Output Audit (BOA). The BOA procedure covers sources of variation at the single machine dosimetry level. It is described in detail here.
Both the Facility Questionnaire and BOA procedures must be completed before a center is allowed to enter patients in a trial.
Note: it is the radiation oncologist and medical physicist responsibility to submit the FQ and provide the BOA results.
Benchmark Case (Dummy Run with delineation exercise)
This procedure covers sources of variation in delineation and planning. It ensures that the specific delineation and dose guidelines for a given trial are well understood by the local investigators. Participating institutions are asked to treat a “dummy” patient according to the protocol. The delineation is reviewed by EORTC experts to ensure protocol compliance. The Benchmark Case is carried out before a centre is allowed to enter patients in the trial.
In some studies, your radiotherapy department will be asked to anonymize, export, zip and upload a whole patient dataset, in order to be sure that there are no connectivity issues (hospital firewall, etc.) between your hospital and the EORTC database. This procedure is conducted before a centre is allowed to enter patients in the trial, so that no delays (concerning the uploading of trial patient datasets) may occur during the trial.
Individual Case Review (ICR)
During the course of a trial some or all of the patients’ RT datasets will be requested for a prospective or retrospective review by a panel of experts. This procedure will cover sources of variation on a single case level. The number of patients to be reviewed is predefined and clearly mentioned in the trial protocol. Sites are informed of the outcome of ICR as soon as possible and, in case this results in an unacceptable protocol variation, they may be requested:
- to re-plan and resubmit the same patient, if the ICR takes place prospectively, or
- another trial patient’s RT dataset, should the ICR takes place retrospectively.
More information on ICR is available here.
Complex Dosimetry Check (CDC)
This procedure is a validation of the correct use of modern radiotherapy techniques, such as IMRT, VMAT and Tomotherapy. It can be performed by scanning an actual IMRT phantom equipped with films and TLDs delivered by an auditing institution and sending it back for evaluation; or participating institutions can irradiate their own in-house IMRT phantom, based on a provided plan such as the same plan used for the Benchmark case, and send both the measurement and TPS dose files back. This procedure is called the Virtual Phantom Procedure. Acceptance criteria will depend on the tumor site and treatment characteristics. The most common acceptance criterion is a 3 mm / 3 % gamma analysis with a 95% agreement.
More information on the CDC is available here.
The whole RTQA team will be more than happy to help you and answer any questions you may have at: firstname.lastname@example.org.