Trial specific review of patients will be identified within the protocol and further described within the RTQA guidelines. The delineation reviews are performed by Radiation Oncologists and the dose and plan reviews by Medical Physicists. Protocol compliance is of paramount importance with ICR studies showing that major protocol deviations can potentially significantly affect trial endpoints such as overall survival.Peters et al J Clin Oncol 28(18):2996-3001, 2010. (PubMed)
The review can be limited to only a selected amount of patients within the trial, or extensive, including all patients within the trial. Furthermore it can be prospective, i.e. the patient’s data is reviewed and accepted as per protocol prior to the patient beginning their treatment, or retrospective, review of the patient’s data after the patient has begun or completed their treatment.
Cases are evaluated with one of three final results:
Acceptable as per protocol:
The radiation therapy treatment was delivered to the patient according to the protocol.
The radiation therapy treatment was delivered to the patient not according to all of the protocol specifications, but no clinical impact affecting the trial outcome is expected due to the deviation(s). The observed protocol deviations do not exceed the defined protocol criteria for an acceptable variation.
The patient has been planned/treated not according to the protocol and the deviation(s) could have a clinical impact on him/her that would affect the trial outcome. The variation(s) exceed the defined protocol’s criteria for an unacceptable variation. The consequence of the deviation(s) is deemed significant enough by the trial Principal Investigator/RTQA reviewer to increase the trial’s uncertainty and thus may increase the probability that the true trial outcome is obscured if the patient’s data was to be included in the trial’s final analysis.
Investigators are required to submit patient data for prospective review within the timelines established in the protocol. Ideally the data should be submitted as soon as delineation/plan is available to allow enough time for the review before the patient’s treatment begins. Feedback will usually be provided within 2 business days of submission, and plans requiring modification must be resubmitted as soon as possible and always within 3 business days. Actual timelines might change depending on the specific study protocol.
Any uploaded case is accompanied by a trial specific webform, completed with relevant RT information.
The data for retrospective review should still be submitted prior to the beginning of treatment; feedback will be provided, usually within 3 months of submission. Any uploaded case is accompanied by a trial-specific webform, completed with relevant RT information.