Jihane Boustani1, Eleonor Rivin Del Campo2, Julie Blanc3, Didier Peiffert4, Karine Benezery5, Renata Pereira6, Emmanuel Rio7, Elisabeth Le Prisé8, Gilles Créhange9, Florence Huguet2. 1. Department of Radiation Oncology, University Hospital Jean Minjoz, Besançon, France; Department of Radiation Oncology, Unicancer-Georges François Leclerc Cancer Center, Dijon, France. Electronic address: jboustani@cgfl.fr. 2. Department of Radiation Oncology, Tenon Hospital, Hôpitaux Universitaires Est Parisien, Sorbonne University Medical Faculty, Paris, France. 3. Department of Biostatistics, Unicancer-Georges François Leclerc Cancer Center, Dijon, France. 4. Department of Radiation Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-Lès-Nancy, France. 5. Department of Radiation Oncology, Centre Antoine Lacassagne, Nice, France. 6. Department of Radiation Oncology, Centre Guillaume Le Conquérant, Le Havre, France. 7. Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Saint-Herblain, France. 8. Department of Radiation Oncology, Centre Eugène Marquis, Rennes, France. 9. Department of Radiation Oncology, Institut Curie, Paris, France.
Abstract
PURPOSE: The ongoing phase 2/3 PRODIGE 26/CONCORDE trial compares chemoradiation therapy with and without dose escalation in patients with locally advanced or unresectable esophageal cancer. The results of a benchmark case procedure are reported here to evaluate the protocol compliance of participating centers as part of quality assurance for radiation therapy. METHODS AND MATERIALS: Volume delineation, target coverage, and dose constraints to the organs at risk (OARs) were assessed on treatment plans of a common benchmark case performed by each participating center. The centers were classified in 3 categories: per protocol, minor acceptable deviation (MiD), or major unacceptable deviation (MaD). A plan was rejected if ≥4 MiDs or 1 MaD were found. RESULTS: Thirty-5 centers submitted 43 plans. Among them, 14 (32.6%) were per protocol, 19 (44.2%) presented at least 1 MiD, 2 (4.6%) presented at least 1 MaD, and 8 (18.6%) presented both MiD and MaD. Overall, 11 (25.6%) plans were rejected. Only 1 plan was rejected because gross tumor volume was not correctly delineated. The OAR delineation was respected in all cases. Dose constraints to the OARs were respected in the majority of cases except for the heart, where one-third of the plans presented a deviation. As for the target volume, 3 plans (5.8%) had a major underdosage and 1 plan (1.9%) had a major overdosage. Overall, 58% of all treatments were planned with intensity modulated radiation therapy, whereas 42% were planned with 3-dimensional chemoradiation therapy. Significantly more plans in the intensity modulated radiation therapy group were accepted compared with the 3-dimensional chemoradiation therapy group (P = .03). CONCLUSION: The high frequency of protocol deviations underlines the importance of a quality assurance program in clinical trials. Further work should assess the impact of quality assurance for radiation therapy on patient outcomes.
PURPOSE: The ongoing phase 2/3 PRODIGE 26/CONCORDE trial compares chemoradiation therapy with and without dose escalation in patients with locally advanced or unresectable esophageal cancer. The results of a benchmark case procedure are reported here to evaluate the protocol compliance of participating centers as part of quality assurance for radiation therapy. METHODS AND MATERIALS: Volume delineation, target coverage, and dose constraints to the organs at risk (OARs) were assessed on treatment plans of a common benchmark case performed by each participating center. The centers were classified in 3 categories: per protocol, minor acceptable deviation (MiD), or major unacceptable deviation (MaD). A plan was rejected if ≥4 MiDs or 1 MaD were found. RESULTS: Thirty-5 centers submitted 43 plans. Among them, 14 (32.6%) were per protocol, 19 (44.2%) presented at least 1 MiD, 2 (4.6%) presented at least 1 MaD, and 8 (18.6%) presented both MiD and MaD. Overall, 11 (25.6%) plans were rejected. Only 1 plan was rejected because gross tumor volume was not correctly delineated. The OAR delineation was respected in all cases. Dose constraints to the OARs were respected in the majority of cases except for the heart, where one-third of the plans presented a deviation. As for the target volume, 3 plans (5.8%) had a major underdosage and 1 plan (1.9%) had a major overdosage. Overall, 58% of all treatments were planned with intensity modulated radiation therapy, whereas 42% were planned with 3-dimensional chemoradiation therapy. Significantly more plans in the intensity modulated radiation therapy group were accepted compared with the 3-dimensional chemoradiation therapy group (P = .03). CONCLUSION: The high frequency of protocol deviations underlines the importance of a quality assurance program in clinical trials. Further work should assess the impact of quality assurance for radiation therapy on patient outcomes.
Authors: Kelsey L Corrigan; Stephen Kry; Rebecca M Howell; Ramez Kouzy; Joseph Abi Jaoude; Roshal R Patel; Anuja Jhingran; Cullen Taniguchi; Albert C Koong; Mary Fran McAleer; Paige Nitsch; Claus Rödel; Emmanouil Fokas; Bruce D Minsky; Prajnan Das; C David Fuller; Ethan B Ludmir Journal: Radiother Oncol Date: 2021-11-25 Impact factor: 6.280
Authors: Sarah Derby; Matthew Forshaw; Caroline Lowrie; Derek Grose; Husam Marashi; Philip McLoone; Christina Wilson; David McIntosh Journal: BMJ Open Gastroenterol Date: 2021-01