Quality assurance of radiotherapy in the ongoing EORTC 1219-DAHANCA-29 trial for HPV/p16 negative squamous cell carcinoma of the head and neck: Results of the benchmark case procedure
| Autor: | M. Tomsej, Vincent Grégoire, Damien C. Weber, Joanna Kazmierska, Angelo F. Monti, Warren Grant, R. Bar-Deroma, Coen W. Hurkmans, Pierre Castadot, Melissa Christiaens, Jens Overgaard, Sandra Collette, Jordi Giralt |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Organs at Risk
medicine.medical_specialty Quality Assurance Health Care medicine.medical_treatment 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Journal Article Medicine Humans Radiology Nuclear Medicine and imaging Medical physics Nimorazole Prospective Studies Head and neck 610 Medicine & health Retrospective Studies Protocol (science) business.industry Squamous Cell Carcinoma of Head and Neck Radiotherapy Planning Computer-Assisted Head and neck cancer Hematology medicine.disease Surgery Clinical trial Radiation therapy DAHANCA Benchmarking Oncology Head and Neck Neoplasms 030220 oncology & carcinogenesis Carcinoma Squamous Cell business Quality assurance medicine.drug |
| Zdroj: | Christiaens, M, Collette, S, Overgaard, J, Gregoire, V, Kazmierska, J, Castadot, P, Giralt, J, Grant, W, Tomsej, M, Bar-Deroma, R, Monti, A F, Hurkmans, C W & Weber, D C 2017, ' Quality assurance of radiotherapy in the ongoing EORTC 1219-DAHANCA-29 trial for HPV/p16 negative squamous cell carcinoma of the head and neck: Results of the benchmark case procedure ', Radiotherapy & Oncology, vol. 123, no. 3, pp. 424-430 . https://doi.org/10.1016/j.radonc.2017.04.019 |
| Popis: | BACKGROUND AND PURPOSE:The phase III EORTC 1219-DAHANCA 29 intergroup trial evaluates the influence of nimorazole in patients with locally advanced head and neck cancer when treated with accelerated radiotherapy (RT) in combination with chemotherapy. This article describes the results of the RT Benchmark Case (BC) performed before patient inclusion.MATERIALS AND METHODS:The participating centers were asked to perform a 2-step BC, consisting of (1) a delineation and (2) a planning exercise according to the protocol guidelines. Submissions were prospectively centrally reviewed and feedback was given to the submitting centers. Sørensen-Dice similarity index (DSI) and the 95th percentile Hausdorff distance (HD) were retrospectively used to evaluate the agreement between the centers and the expert contours.RESULTS:Fifty-four submissions (34 delineation and 20 planning exercises) from 19 centers were reviewed. Nine (47%) centers needed to perform the delineation step twice and three (16%) centers 3 times before receiving an approval. An increase in DSI-value and a decrease in HD, in particular for the prophylactic Clinical Target Volume (pCTV), could be found for the resubmitted cases. No unacceptable variations could be found for the planning exercise.CONCLUSIONS:These BC-results highlight the need for effective and prospective RTQA in clinical trials. Even with clearly defined protocol guidelines, delineation and not planning remain the main reason for unacceptable protocol variations. The introduction of more objective quantitative analysis methods, such as the HD and DSI, in future trials might strengthen the evaluation by experts. BACKGROUND AND PURPOSE: The phase III EORTC 1219-DAHANCA 29 intergroup trial evaluates the influence of nimorazole in patients with locally advanced head and neck cancer when treated with accelerated radiotherapy (RT) in combination with chemotherapy. This article describes the results of the RT Benchmark Case (BC) performed before patient inclusion.MATERIALS AND METHODS: The participating centers were asked to perform a 2-step BC, consisting of (1) a delineation and (2) a planning exercise according to the protocol guidelines. Submissions were prospectively centrally reviewed and feedback was given to the submitting centers. Sørensen-Dice similarity index (DSI) and the 95th percentile Hausdorff distance (HD) were retrospectively used to evaluate the agreement between the centers and the expert contours.RESULTS: Fifty-four submissions (34 delineation and 20 planning exercises) from 19 centers were reviewed. Nine (47%) centers needed to perform the delineation step twice and three (16%) centers 3 times before receiving an approval. An increase in DSI-value and a decrease in HD, in particular for the prophylactic Clinical Target Volume (pCTV), could be found for the resubmitted cases. No unacceptable variations could be found for the planning exercise.CONCLUSIONS: These BC-results highlight the need for effective and prospective RTQA in clinical trials. Even with clearly defined protocol guidelines, delineation and not planning remain the main reason for unacceptable protocol variations. The introduction of more objective quantitative analysis methods, such as the HD and DSI, in future trials might strengthen the evaluation by experts. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|