Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2025
Image-guided intensity-modulated radiotherapy with reduced margins in patients with prostate cancer: Results of the RCMIGI randomized phase II trial.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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.
Riou Olivier, Fenoglietto Pascal, Jarlier Marta, Prunaretty Jessica, Aillères Norbert, Poinas Grégoire, Debuire Pierre, Gourgou Sophie, Meignant Laetitia, Segui Bruno, Llacer Moscardo Carmen, Charissoux Marie, Azria David
Аннотация
BACKGROUND AND PURPOSE: Intensity-modulated (IMRT) and image-guided (IGRT) radiotherapies reduce radiation-induced toxicities in localized prostate cancer. This randomized phase II trial (NCT03254420) evaluated late pelvic toxicity (LPT) and quality of life after IMRT/IGRT with standard or reduced margins in patients with low- to intermediate-risk prostate cancer.
MATERIALS AND METHODS: Between August 2016 and May 2022, 74 patients were randomized (1:2) to IMRT/IGRT with standard (Control, n = 30) or reduced (Experimental, n = 44) margins. Control IGRT used cone-beam computed tomography (CBCT), while experimental IGRT combined CBCT with real-time tracking (Calypso® 4D Localization System) and smaller margins. Prostate margins were 3 mm in the Experimental arm versus 1 cm (0.5 cm posteriorly) in the Control arm. The primary endpoint was grade ≥ 2 LPT (CTCAE v4.03). Toxicities were assessed by physician-scored CTCAE and patient-reported quality-of-life outcomes.
RESULTS: Grade ≥ 2 LPT occurred in 5 patients in each arm. Over the study period, 88.6 % (95 % CI: 75.4-96.2) of patients in the Experimental arm and 80.8 % (95 % CI: 60.6-93.4) in the Control arm did not experience a grade ≥ 2 LPT. Under conventional fractionation, the Experimental arm had significantly lower rectal (V70Gy, D50%) and bladder (D50%, V70Gy, V76Gy) doses (p < 0.01), but higher rectal (D1%, V76Gy) and bladder (V80Gy) doses (p < 0.01). At two years post-radiotherapy, urinary symptom scores were significantly lower in the Experimental arm (mean 12.3 vs. 21.2, p = 0.028).
CONCLUSION: IMRT/IGRT with reduced margins is feasible and may improve some dosimetric outcomes. Both arms had low LPT rates, but reduced margins may improve patient-reported urinary symptoms.
MATERIALS AND METHODS: Between August 2016 and May 2022, 74 patients were randomized (1:2) to IMRT/IGRT with standard (Control, n = 30) or reduced (Experimental, n = 44) margins. Control IGRT used cone-beam computed tomography (CBCT), while experimental IGRT combined CBCT with real-time tracking (Calypso® 4D Localization System) and smaller margins. Prostate margins were 3 mm in the Experimental arm versus 1 cm (0.5 cm posteriorly) in the Control arm. The primary endpoint was grade ≥ 2 LPT (CTCAE v4.03). Toxicities were assessed by physician-scored CTCAE and patient-reported quality-of-life outcomes.
RESULTS: Grade ≥ 2 LPT occurred in 5 patients in each arm. Over the study period, 88.6 % (95 % CI: 75.4-96.2) of patients in the Experimental arm and 80.8 % (95 % CI: 60.6-93.4) in the Control arm did not experience a grade ≥ 2 LPT. Under conventional fractionation, the Experimental arm had significantly lower rectal (V70Gy, D50%) and bladder (D50%, V70Gy, V76Gy) doses (p < 0.01), but higher rectal (D1%, V76Gy) and bladder (V80Gy) doses (p < 0.01). At two years post-radiotherapy, urinary symptom scores were significantly lower in the Experimental arm (mean 12.3 vs. 21.2, p = 0.028).
CONCLUSION: IMRT/IGRT with reduced margins is feasible and may improve some dosimetric outcomes. Both arms had low LPT rates, but reduced margins may improve patient-reported urinary symptoms.