Quality assurance for the EORTC 22071–26071 study: dummy run prospective analysis

Abstract

PurposeThe phase III 22071–26071 trial was designed to evaluate the addition of panitumumab to adjuvant chemotherapy plus intensity modulated radiotherapy (IMRT) in locally advanced resected squamous cell head and neck cancer. We report the results of the dummy run (DR) performed to detect deviations from protocol guidelines.Methods and MaterialsDR datasets consisting of target volumes, organs at risk (OAR) and treatment plans were digitally uploaded, then compared with reference contours and protocol guidelines by six central reviewers. Summary statistics and analyses of potential correlations between delineations and plan characteristics were performed.ResultsOf 23 datasets, 20 (87.0%) GTVs were evaluated as acceptable/borderline, along with 13 (56.5%) CTVs and 10 (43.5%) PTVs. All PTV dose requirements were met by 73.9% of cases. Dose constraints were met for 65.2-100% of mandatory OARs. Statistically significant correlations were observed between the subjective acceptability of contours and the ability to meet dose constraints for all OARs (p ≤ 0.01) except for the parotids and spinal cord. Ipsilateral parotid doses correlated significantly with CTV and PTV volumes (p ≤ 0.05).ConclusionsThe observed wide variations in treatment planning, despite strict guidelines, confirms the complexity of development and quality assurance of IMRT-based multicentre studies for head and neck cancer.Electronic supplementary materialThe online version of this article (doi:10.1186/s13014-014-0248-9) contains supplementary material, which is available to authorized users.

Brachytherapy quality assurance in the PORTEC-4a trial for molecular-integrated risk profile guided adjuvant treatment of endometrial cancer

“…A review on QA for radiotherapy in randomised trials showed that major protocol deviations were observed in 11.0-48.0% of all cases, and were reported to be associated with impaired overall survival and local control and potentially increased treatment related toxicity [15]. This has also been reported by several other investigators, emphasising that the design of the QA-procedure needs to be tailored to specific trial techniques and outcomes [20,22,23,[32][33][34].…”

“…Especially for radiotherapy trials in general, QA is considered essential as a decrease in therapeutic effectiveness and impaired trial outcomes by protocol deviations have been reported [15,16]. Furthermore, QA increases trial protocol adherence and treatment uniformity, and therewith ensures optimal treatment in both arms which leads to more reliable trial outcomes [17][18][19][20][21][22][23].…”

Radiotherapy Quality Assurance for Head and Neck Squamous Cell Carcinoma

“…Learning from the negative experience of the TROG 0202 study, the EORTC organized an extended "dummy run" for their phase III EORTC 22071-26071 study designed to evaluate the addition of panitumumab to adjuvant chemo-IMRT in locally advanced, resected squamous cell HNC (19,26) A computed tomography dataset comprising one case of NHC was sent to the participating institutions and then compared with reference contours and protocol guidelines by six central reviewers. Of the 23 datasets, 13% of the GTV (gross tumor volume = macroscopic disease), 44% of the CTV (clinical TV = zone of possible microscopic extension), and 57% of the PTV (planning TV = margin for movement and setup uncertainty) contours were evaluated unacceptable (objectives and constraints defined per protocol and taking into account all available information along with ICRU recommendations) by the expert panel.…”

“…While strict adherence to ICRU 83 guidelines on "Prescribing, Recording, and Reporting Intensity-Modulated Photon-Beam Therapy" can address most of the (QA) issues required to obtain adequate dose distribution during planning and delivery, work is still required to achieve consensus and QA of contouring (28). In addition to the study by Fairchild et al mentioned above, the PARSPORT study also found large differences in contouring in 3 out of 10 submissions due to lack of adherence to the trial guidelines (26,29). The Swiss national "dummy run" study found that more precise radiological imaging could increase homogeneity in delineation of the GTV (30).…”

Contour variation is a primary source of error when delivering post prostatectomy radiotherapy: Results of the Trans‐Tasman Radiation Oncology Group 08.03 Radiotherapy Adjuvant Versus Early Salvage (RAVES) benchmarking exercise

“…is a trial‐specific benchmarking exercise to assess an institution's ability to understand and comply with trial protocol contouring and dosimetric requirements. A benchmarking exercise as part of QART has been reported for clinical trials involving many anatomical sites including head and neck, gynaecological and intact prostate . Matzinger et al .…”