Title :

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

Author(s) :

Magnin, Joséphine [Auteur correspondant]
Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand [CHU Dijon]
INSERM-TRANSFERT [Paris] [IT]
Fournel, Isabelle [Auteur]
Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques [CIC-EC]
Doussot, Alexandre [Auteur]
Centre Hospitalier Régional Universitaire de Besançon [CHRU Besançon]
Régimbeau, Jean-Marc [Auteur]
Chirurgie digestive [CHU Amiens]
Simplification des soins chez les patients complexes - UR UPJV 7518 [SSPC]
Zerbib, Philippe [Auteur]
Hôpital Claude Huriez [Lille]
Institute for Translational Research in Inflammation - U 1286 [INFINITE]
Piessen, Guillaume [Auteur]
Hôpital Claude Huriez [Lille]
Hétérogénéité, Plasticité et Résistance aux Thérapies des Cancers = Cancer Heterogeneity, Plasticity and Resistance to Therapies - UMR 9020 - U 1277 [CANTHER]
Beyer-Berjot, Laura [Auteur]
MICrobiologie de l'ALImentation au Service de la Santé [MICALIS]
Laboratoire de Biomécanique Appliquée [LBA UMR T24]
Deguelte, Sophie [Auteur]
Hôpital universitaire Robert Debré [Reims] [CHU Reims]
Lakkis, Zaher [Auteur]
Centre Hospitalier Régional Universitaire de Besançon [CHRU Besançon]
Schwarz, Lilian [Auteur]
CHU Rouen
Orry, David [Auteur]
Service de chirurgie [Centre Georges-François Leclerc]
Ayav, Ahmet [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Faculté de Médecine [Nancy]
Muscari, Fabrice [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Mauvais, François [Auteur]
Chirurgie digestive [CHU Amiens]
Passot, Guillaume [Auteur]
Service d'Oncologie Médicale [Centre hospitalier Lyon Sud - HCL]
Université de Lyon
Trelles, Nelson [Auteur]
Centre Hospitalier René Dubos [Pontoise]
Venara, Aurélien [Auteur]
Université d'Angers [UA]
Benoist, Stéphane [Auteur]
Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
Messager, Mathieu [Auteur]
Centre Hospitalier Gustave Dron [Tourcoing]
Fuks, David [Auteur]
Hôpital Cochin [AP-HP]
Institut Cochin [IC UM3 (UMR 8104 / U1016)]
Borraccino, Baptiste [Auteur]
Centre hospitalier d'Auxerre [CHA]
Trésallet, Christophe [Auteur]
Hôpital Avicenne [AP-HP]
Valverde, Alain [Auteur]
Groupe Hospitalier Diaconesses Croix Saint-Simon
Souche, François-Régis [Auteur]
Centre Hospitalier Régional Universitaire [Montpellier] [CHRU Montpellier]
Institut de Recherche en Cancérologie de Montpellier [IRCM - U1194 Inserm - UM]
Herrero, Astrid [Auteur]
Centre Hospitalier Régional Universitaire [Montpellier] [CHRU Montpellier]
Université de Montpellier [UM]
Gaujoux, Sébastien [Auteur]
CHU Pitié-Salpêtrière [AP-HP]
Lefevre, Jérémie [Auteur]
CHU Saint-Antoine [AP-HP]
Paris Center for Microbiome Medicine [FHU PaCeMM]
Bourredjem, Abderrahmane [Auteur]
Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie [CIC-P803]
Cransac, Amélie [Auteur]
Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand [CHU Dijon]
Ortega-Deballon, Pablo [Auteur]
Service de Chirurgie Digestive, Cancérologique, Générale, Endocrinienne et Urgences (CHU de Dijon)

Journal title :

BMC Cancer

Pages :

913

Publisher :

BioMed Central

Publication date :

2022-08-23

ISSN :

1471-2407

English keyword(s) :

cancer-related outcomes
Digestive surgical oncology
Perioperative corticosteroids
Postoperative morbidity
Randomized placebo-controlled trial

HAL domain(s) :

Sciences du Vivant [q-bio]/Médecine humaine et pathologie

English abstract : [en]

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 ...
Show more >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 .Show less >

Language :

Anglais

Peer reviewed article :

Oui

Audience :

Internationale

Popular science :

Non

Collections :

• Cancer Heterogeneity, Plasticity and Resistance to Therapies (CANTHER) - UMR 9020 - UMR 1277

Source :

Harvested from HAL