Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2026
Induction chemotherapy followed by chemoradiotherapy in patients with locally advanced anal cancers: The PRODIGE 85-FFCD 1804-KANALRAD trial.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Medjahdi Sophia, Kim Stefano, Lemanski Claire, Malicot Karine Le, Giraud Nicolas, Naessens Clara, Durand Bénédicte, Smith Denis, Frulio Nora, Huguet Florence, Vendrely Véronique
Аннотация
The PRODIGE 85-FFCD 1804-KANALRAD trial has been designed as a multicenter, randomized, open-label, phase III trial to compare the efficacy of induction chemotherapy (4 cycles of modified DCF: Docetaxel, Cisplatin, and 5-Fluorouracil) prior to standard chemoradiotherapy (CRT) versus standard CRT alone for histologically proven locally advanced squamous cell carcinomas of the anal canal (SCCA), either T3-4 or with lymph node involvement and no metastases. The primary endpoint is event-free survival at 2 years. Secondary endpoints include disease-free survival, complete response rate, patient quality of life, and monitoring of treatment-associated toxicities. A safety analysis is planned after enrollment of the 20 first patients in the experimental arm to ensure the feasibility of CRT after induction chemotherapy. In addition, genetic and epigenetic studies from tissue and circulating DNA will be conducted to assess their prognostic or predictive value. Overall, 310 patients will be recruited in France and will be followed for 3 years after randomization.