Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2025
Radiotherapy quality assurance of patients with squamous cell carcinoma of the head and neck included in the DAHANCA 19 randomised phase III trial.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Hansen C R, Samsøe E, Smulders B, Sand H M B, Holm A I S, Furre T, Jensen K, Johansen J, Maare C, Kristensen C A, Andersen M, Bratland Å, Grau C, Eriksen J G, Overgaard J
Аннотация
BACKGROUND AND PURPOSE: The current study investigates the radiotherapy quality assurance (QA) of the DAHANCA 19 randomised phase III trial comparing standard chemo-radiotherapy with and without Zalutumumab.
MATERIAL AND METHODS: The complete radiotherapy datasets for 608 patients were collected centrally. QA parameters were extracted, including dose to the primary target volume, spinal cord and brainstem, and overall treatment time. These parameters were compared to DAHANCA RTQA guidelines and categorised into no, minor or major deviations.
RESULTS: Among the 608 patients eligible for analyses, 118 had one minor deviation, 20 had two minor, and two had three minor deviations. Fifteen patients (2.5 %) had major deviations, with 13 related to overall treatment time or high-dose target volume coverage. Of the major deviations, 12 were in the experimental arm, and 3 were in the control arm (p = 0.02). Most major deviations were deemed clinically unavoidable and, therefore, not considered violations of clinical practice. There was no difference in outcomes between patients with minor deviations and those without deviations, aligning with current definitions and guidelines. Patients with major deviations did not have inferior loco-regional or disease-specific survival compared to those without deviations. However, they had significantly worse survival, which was not attributed to radiotherapy.
CONCLUSIONS: The treatment plans in DAHANCA 19 adhered well to national guidelines. Most major deviations were observed in the experimental arm but did not affect the local treatment control. No indication that compromised RT-QA affected the conclusions of DAHANCA 19 was found.
MATERIAL AND METHODS: The complete radiotherapy datasets for 608 patients were collected centrally. QA parameters were extracted, including dose to the primary target volume, spinal cord and brainstem, and overall treatment time. These parameters were compared to DAHANCA RTQA guidelines and categorised into no, minor or major deviations.
RESULTS: Among the 608 patients eligible for analyses, 118 had one minor deviation, 20 had two minor, and two had three minor deviations. Fifteen patients (2.5 %) had major deviations, with 13 related to overall treatment time or high-dose target volume coverage. Of the major deviations, 12 were in the experimental arm, and 3 were in the control arm (p = 0.02). Most major deviations were deemed clinically unavoidable and, therefore, not considered violations of clinical practice. There was no difference in outcomes between patients with minor deviations and those without deviations, aligning with current definitions and guidelines. Patients with major deviations did not have inferior loco-regional or disease-specific survival compared to those without deviations. However, they had significantly worse survival, which was not attributed to radiotherapy.
CONCLUSIONS: The treatment plans in DAHANCA 19 adhered well to national guidelines. Most major deviations were observed in the experimental arm but did not affect the local treatment control. No indication that compromised RT-QA affected the conclusions of DAHANCA 19 was found.