e-Article
Benefit of a flash dose of corticosteroids in digestive surgical oncology: a multicenter, randomized, double blind, placebo-controlled trial (CORTIFRENCH)
Document Type
article
Author
Joséphine Magnin; Isabelle Fournel; Alexandre Doussot; Jean-Marc Régimbeau; Philippe Zerbib; Guillaume Piessen; Laura Beyer-Berjot; Sophie Deguelte; Zaher Lakkis; Lilian Schwarz; David Orry; Ahmet Ayav; Fabrice Muscari; François Mauvais; Guillaume Passot; Nelson Trelles; Aurélien Venara; Stéphane Benoist; Mathieu Messager; David Fuks; Baptiste Borraccino; Christophe Trésallet; Alain Valverde; François-Régis Souche; Astrid Herrero; Sébastien Gaujoux; Jérémie Lefevre; Abderrahmane Bourredjem; Amélie Cransac; Pablo Ortega-Deballon
Source
BMC Cancer, Vol 22, Iss 1, Pp 1-9 (2022)
Subject
Language
English
ISSN
1471-2407
Abstract
Abstract Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT03875690, Registered on March 15, 2019, URL: https://clinicaltrials.gov/ct2/show/NCT03875690 .