Induction chemotherapy followed by chemoradiotherapy in patients with locally advanced anal cancers: The PRODIGE 85-FFCD 1804-KANALRAD trial
Year: 2026
Type: article
Study design: Study Protocol
Abstract: 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.
Source: Digestive and Liver Disease
Institutions: Centre Hospitalier Universitaire de Limoges, Centre Hospitalier Universitaire de Besançon, Inserm, Fédération Francophone de Cancérologie Digestive, Centre de recherche Translationnelle en Médecine moléculaire, Centre Hospitalier Universitaire de Bordeaux, Sorbonne Université, Assistance Publique – Hôpitaux de Paris, Hôpital Tenon, Université de Bordeaux, BoRdeaux Institute of onCology
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,300
OpenAlex ID: W7124271788
