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Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology : A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial (CORTIFRENCH).

Joséphine Magnin 1, 2, * Isabelle Fournel 3 Alexandre Doussot 4 Jean-Marc Régimbeau 5, 6 Philippe Zerbib 7 Guillaume Piessen 8 Laura Beyer-Berjot 9 Sophie Deguelte 10 Zaher Lakkis 11 Lilian Schwarz 12 David Orry 13 Ahmet Ayav 14, 15 Fabrice Muscari 16 François Mauvais 5, 17 Guillaume Passot 18, 19 Nelson Trelles 20 Aurélien Venara 21 Stéphane Benoist 22 Mathieu Messager 23 David Fuks 24, 25 Baptiste Borraccino 26 Christophe Trésallet 27 Alain Valverde 28 François-Régis Souche 29 Astrid Herrero 29, 30 Sébastien Gaujoux 31 Jérémie Lefevre 32, 33 Abderrahmane Bourredjem 34 Amélie Cransac 1 Pablo Ortega-Deballon 35 
* Auteur correspondant
Abstract : The modulation of perioperative inflammation seems crucial to improve postoperative morbidity and cancer-related outcomes in patients undergoing oncological surgery. Data from the literature suggest that perioperative corticosteroids decrease inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery. Their benefit on cancer-related outcomes has not been assessed. The CORTIFRENCH trial is a phase III multicenter randomized double-blind placebo-controlled trial to assess the impact of a flash dose of preoperative corticosteroids versus placebo on postoperative morbidity and cancer-related outcomes after elective curative-intent surgery for digestive cancer. The primary endpoint is the frequency of patients with postoperative major complications occurring within 30 days after surgery (defined as all complications with Clavien-Dindo grade\,>\,2). The secondary endpoints are the overall survival at 3 years, the disease-free survival at 3 years, the frequency of patients with intraabdominal infections and postoperative infections within 30 days after surgery and the hospital length of stay. We hypothesize a reduced risk of major complications and a better disease-survival at 3 years in the experimental group. Allowing for 5% of drop-out, 1 200 patients (600 per arm) should be included. This will be the first trial focusing on the impact of perioperative corticosteroids on cancer related outcomes. If significant, it might be a strong improvement on oncological outcomes for patients undergoing surgery for digestive cancers. https://clinicaltrials.gov/ct2/show/NCT03875690 .
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https://hal-u-picardie.archives-ouvertes.fr/hal-03760909
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Soumis le : jeudi 25 août 2022 - 16:54:54
Dernière modification le : vendredi 9 septembre 2022 - 10:20:08

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Joséphine Magnin, Isabelle Fournel, Alexandre Doussot, Jean-Marc Régimbeau, Philippe Zerbib, et al.. Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology : A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial (CORTIFRENCH).. BMC Cancer, BioMed Central, 2022, 22 (1), pp. 913. ⟨10.1186/s12885-022-09998-z⟩. ⟨hal-03760909⟩

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