Quality Assurance of Dose-Escalated Radiation Therapy in a Randomized Trial for Locally Advanced Oesophageal cancer

Autor: Renata Pereira, Elisabeth Le Prisé, Florence Huguet, Emmanuel Rio, K. Benezery, Jihane Boustani, Gilles Créhange, Eleonor Rivin del Campo, Julie Blanc, Didier Peiffert
Rok vydání: 2019
Předmět:
Male
Organs at Risk
Cancer Research
Esophageal Neoplasms
Organoplatinum Compounds
Quality Assurance
Health Care
medicine.medical_treatment
Leucovorin
Kidney
030218 nuclear medicine & medical imaging
law.invention
0302 clinical medicine
Randomized controlled trial
law
Antineoplastic Combined Chemotherapy Protocols
Lung
Radiation
Heart
Radiotherapy Dosage
Chemoradiotherapy
Tumor Burden
Benchmarking
Liver
Spinal Cord
Oncology
030220 oncology & carcinogenesis
Carcinoma
Squamous Cell
Fluorouracil
France
Guideline Adherence
Radiology
medicine.medical_specialty
Locally advanced
Protocol Deviation
Cancer Care Facilities
Drug Administration Schedule
03 medical and health sciences
medicine
Humans
Radiology
Nuclear Medicine and imaging
Aged
Protocol (science)
Lymphatic Irradiation
business.industry
Radiotherapy Planning
Computer-Assisted
Cancer
medicine.disease
Clinical trial
Radiation therapy
Lymph Nodes
Radiotherapy
Intensity-Modulated
Cisplatin
Radiotherapy
Conformal
business
Quality assurance
Zdroj: International Journal of Radiation Oncology*Biology*Physics. 105:329-337
ISSN: 0360-3016
DOI: 10.1016/j.ijrobp.2019.06.2542
Popis: 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.
Databáze: OpenAIRE
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