CORTIFRENCH - Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial
interventional
N/A
1 country
25
to assess the impact of a flash dose of preoperative corticosteroids versus placebo on the onset of major complications after elective curative-intent surgery for digestive cancer
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 24, 2024
Actual (reported)frequency of patients with postoperative major complications occurring within 30 days after surgery (D30) and defined as all complications with Clavien-Dindo grade>2
Efficacy: - Overall survival at 3 years (time from surgery to death from any cause)
Efficacy: Disease-free survival at 3 years (time from surgery to first documented progressive disease or death from any cause, whichever occurs first)
Efficacy: Frequency of patients with postoperative infections occurring within 30 days after surgery and defined according to the CDC definitions
Efficacy: Frequency of patients with intraabdominal infections (including anastomotic fistula and intraabdominal abscess) within 30 days after surgery (CDC definition)
Efficacy: Number of hospitalization days. In case of death, the patient will be considered as hospitalized until D30
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
SOLUMEDROL 500 mg, poudre pour solution injectable
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
SOLUMEDROL 500 mg, poudre pour solution injectable
Named ingredient: Methylprednisolone Hemisuccinate
View registry recordCentre Hospitalier Simone Veil De Beauvais
Beauvais, 60000, France
Assistance Publique Hopitaux De Paris
Paris, 75014, France
Centre Hospitalier Universitaire Reims
Reims, 51100, France
Chef de projets recherche
First Submitted
June 24, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Assistance Publique Hopitaux De Paris
Paris, 75013, France
Centre Hospitalier Universitaire De Montpellier
Montpellier Cedex 5, 34295, France
Centre Hospitalier D Auxerre
Auxerre, 89000, France
Centre Hospitalier Universitaire De Lille
Lille Cedex, 59037, France
Centre Hospitalier Regional D'Angers
Angers, 49100, France
Centre Hospitalier Universitaire Rouen
Rouen Cedex, 76031, France
Centre Hospitalier Universitaire De Toulouse
Toulouse Cedex 9, 31059, France
Assistance Publique Hopitaux De Paris
Bobigny, 93000, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020, France
HOPITAL ROBERT SCHUMAN DE VANTOUX
Vantoux, 57070, France
Centre Hospitalier Universitaire Amiens Picardie
Amiens, 80080, France
Centr Georges Francois Leclerc
Dijon, 21000, France
Hopital NOVO
Pontoise, 95300, France
Centre Hospitalier Regional De Marseille
Marseille, 13015, France
Centre Hospitalier Universitaire De Montpellier
Montpellier Cedex 5, 34295, France
Centre Hospitalier Universitaire De Lille
Lille Cedex, 59037, France
CHRU De Nancy
Vandoeuvre Les Nancy, 54500, France
Centre Hospitalier De Tourcoing
Tourcoing Cedex, 59208, France
Hospices Civils De Lyon
Pierre Benite, 69310, France
Centre Hospitalier Universitaire De Dijon
Dijon, 21000, France
Assistance Publique Hopitaux De Paris
Le Kremlin-Bicetre, 94270, France
CHU Besancon
Besancon, 25000, France