Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology : A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial (CORTIFRENCH). - Université de Picardie Jules Verne Accéder directement au contenu
Article Dans Une Revue BMC Cancer Année : 2022

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

1 CHU Dijon - Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
2 IT - INSERM-TRANSFERT [Paris]
3 CIC-EC - Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques
4 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
5 Chirurgie digestive [CHU Amiens]
6 SSPC - Simplification des soins chez les patients complexes - UR UPJV 7518
7 Hôpital Claude Huriez [Lille]
8 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
9 MICALIS - MICrobiologie de l'ALImentation au Service de la Santé
10 LBA UMR T24 - Laboratoire de Biomécanique Appliquée
11 Hôpital universitaire Robert Debré [Reims]
12 CHU Rouen
13 Service de chirurgie [Centre Georges-François Leclerc]
14 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
15 Faculté de Médecine [Nancy]
16 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
17 Service d'Oncologie Médicale [Centre hospitalier Lyon Sud - HCL]
18 Université de Lyon
19 Centre Hospitalier René Dubos [Pontoise]
20 UA - Université d'Angers
21 AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)
22 Centre Hospitalier Gustave Dron [Tourcoing]
23 Hôpital Cochin [AP-HP]
24 IC UM3 (UMR 8104 / U1016) - Institut Cochin
25 CHA - Centre hospitalier d'Auxerre
26 Hôpital Avicenne [AP-HP]
27 Groupe Hospitalier Diaconesses Croix Saint-Simon
28 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
29 IRCM - U1194 Inserm - UM - Institut de Recherche en Cancérologie de Montpellier
30 UM - Université de Montpellier
31 CHU Pitié-Salpêtrière [AP-HP]
32 CHU Saint-Antoine [AP-HP]
33 FHU PaCeMM - Paris Center for Microbiome Medicine
34 CIC-P803 - Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie
35 Service de Chirurgie Digestive, Cancérologique, Générale, Endocrinienne et Urgences (CHU de Dijon)
Lilian Schwarz
  • Fonction : Auteur
Fabrice Muscari
François Mauvais
  • Fonction : Auteur
  • PersonId : 1151813
  • IdRef : 070688257

Résumé

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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Dates et versions

hal-03760909 , version 1 (07-06-2023)

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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, 2022, 22 (1), pp. 913. ⟨10.1186/s12885-022-09998-z⟩. ⟨hal-03760909⟩
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