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, 10) , Sophie Deguelte (11) , Zaher Lakkis (12) , Lilian Schwarz (13) , David Orry (14) , Ahmet Ayav (15, 16) , Fabrice Muscari (17) , François Mauvais (5, 18) , Guillaume Passot (19, 20) , Nelson Trelles (21) , Aurélien Venara (22) , Stéphane Benoist (23) , Mathieu Messager (24) , David Fuks (25, 26) , Baptiste Borraccino (27) , Christophe Trésallet (28) , Alain Valverde (29) , François-Régis Souche (30) , Astrid Herrero (30, 31) , Sébastien Gaujoux (32) , Jérémie Lefevre (33, 34) , Abderrahmane Bourredjem (35) , Amélie Cransac (1) , Pablo Ortega-Deballon (36)

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 [Lille]
9 MICALIS - MICrobiologie de l'ALImentation au Service de la Santé
10 LBA UMR T24 - Laboratoire de Biomécanique Appliquée
11 CHU Reims - Centre Hospitalier Universitaire de Reims
12 Department of Hepatology, University Hospital of Besançon, 25000 Besançon
13 Hospital and University of Rouen
14 Service de chirurgie [Centre Georges-François Leclerc]
15 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
16 Faculté de Médecine [Nancy]
17 Hôpital Universitaire de Rangueil
18 CH Simone Veil - Centre Hospitalier Simone Veil
19 Service d'Oncologie Médicale [Centre hospitalier Lyon Sud - HCL]
20 Université de Lyon
21 Centre Hospitalier René Dubos [Pontoise]
22 University of Angers, Angers Hospital
23 AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)
24 Centre Hospitalier Gustave Dron [Tourcoing]
25 Hôpital Cochin [AP-HP]
26 Université de Paris, Institut Cochin, CNRS, INSERM, F-75014 Paris, France
27 CHA - Centre hospitalier d'Auxerre
28 Service de chirurgie digestive, bariatrique et endocrinienne, hôpitaux universitaires Paris Seine-Saint-Denis, hôpital Avicenne, Bobigny, France
29 Groupe Hospitalier Diaconesses Croix Saint-Simon
30 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
31 UM - Université de Montpellier
32 Service de Chirurgie Digestive, Hépato-Bilio-pancréatique et Transplantation Hépatique [CHU Pitié-Salpétrière]
33 Service de chirurgie générale et digestive [CHU Saint-Antoine]
34 FHU PaCeMM - Paris Center for Microbiome Medicine
35 CIC-P803 - Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie
36 Service de Chirurgie Digestive, Cancérologique, Générale, Endocrinienne et Urgences (CHU de Dijon)

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 .

Mots clés: cancer-related outcomes; Digestive surgical oncology; Perioperative corticosteroids; Postoperative morbidity; Randomized placebo-controlled trial

Domaines: Médecine humaine et pathologie

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⟩