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    Summary
    EudraCT Number:2018-004852-39
    Sponsor's Protocol Code Number:ORTEGA-PHRCK-2017
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2018-004852-39
    A.3Full title of the trial
    Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial
    Intérêt d'une dose flash de corticoïdes dans la chirurgie des cancers digestifs: un essai randomisé, en double aveugle, contrôlé par placebo (CORTIFRENCH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intérêt d'une dose flash de corticoïdes dans la chirurgie des cancers digestifs
    A.3.2Name or abbreviated title of the trial where available
    CORTIFRENCH
    A.4.1Sponsor's protocol code numberORTEGA-PHRCK-2017
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU Dijon Bourgogne
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Dijon Bourgogne
    B.5.2Functional name of contact pointChef de projets recherche
    B.5.3 Address:
    B.5.3.1Street Address1, boulevard Jeanne d'Arc
    B.5.3.2Town/ cityDijon
    B.5.3.4CountryFrance
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name méthylprednisolone
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chirurgie programmée pour cancer digestif
    E.1.1.1Medical condition in easily understood language
    chirurgie programmée pour cancer digestif
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the impact of a flash dose of preoperative corticosteroids versus placebo on the onset of major complications (Clavien-Dindo >2) within 30 days after elective curative-intent surgery for digestive cancer.
    Evaluer l'impact d’une dose flash préopératoire de corticoïdes par rapport au placebo sur la survenue de complications majeures après une chirurgie à visée curative programmée pour cancer digestif
    E.2.2Secondary objectives of the trial
    1. EFFICACY: to assess the effect of a perioperatoive flash of corticosteroids versus placebo on :
    - Overall survival at 3 years
    - Disease-free survival at 3 years
    - Postoperative infections at D30
    - Intraabdominal infections at D30
    - Hospital stay duration

    2. SAFETY : to assess the safety of perioperative flash of corticosteroids.
    1- Efficacité : évaluer l'effet d'une dose flash préopératoire de corticostéroïdes versus placebo sur :
    - La survie globale à 3 ans
    - La survie sans maladie à 3 ans
    - Les infections postopératoires à J30
    - Les infections intra-abdominales à J30
    - La durée du séjour à l'hôpital

    2- Sécurité : évaluer les risques associés à une dose flash préopératoire de corticostéroïdes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Undergoing elective surgery for a digestive cancer (except purely hepatic surgery)
    - Patients operated in a curative intent
    - Patients who had given their written informed consent
    - Patients affiliated to a National health insurance scheme
    - Age ≥ 18 ans
    - Patient bénéficiant d’une chirurgie programmée pour un cancer digestif (sauf chirurgie purement hépatique)
    - Chirurgie à visée curative
    - Patient ayant donné son consentement écrit éclairé.
    - Personne affiliée ou bénéficiaire à un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Emergency surgery
    - Pregnant or breastfeeding women
    - Patients with an ongoing oral treatment by steroids
    - Palliative surgery
    - Exclusive liver surgery
    - Colorectal resection with concomitant hyperthermic intraperitoneal chemotherapy
    - Patient with at least one contra-indication to methylprednisolone treatment :
    * active infection
    * on course viral disease (particularly hepatitis, herpes, chickenpox, herpes zoster
    * uncontrolled psychotic state
    * hypersensitivity to methylprednisolone or to one of its excipient
    - ASA grade >3
    - Persons subject to a measure of legal protection (guardianship, tutorship)
    - Persons subject to a court order
    - Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
    - Chirurgie en urgence
    - Femmes enceintes ou allaitantes
    - Patients sous corticothérapie au long cours par voie orale
    - Chirurgie palliative
    - Chirurgie exclusivement hépatique
    - Résection colorectale avec chimiothérapie intrapéritonéale hyperthermique concomitante
    - Patient présentant au moins une contre-indication au traitement par méthylprednisolone :
    * infection en cours
    * virose évolutive (en particulier hépatite, herpès, varicelle, zona)
    * état psychotique non contrôlé par un traitement
    * hypersensibilité à la méthylprednisolone ou à l'un de ses excipients
    - ASA grade >3
    - Personne faisant l’objet d’une mesure de protection légale (curatelle, tutelle)
    - Personne faisant l’objet d’une mesure de sauvegarde de justice
    - Impossibilité de signer le document de consentement éclairé ou d'adhérer au suivi médical de l'essai pour des raisons géographiques, sociales ou psychologiques
    E.5 End points
    E.5.1Primary end point(s)
    Frequency of patients with major postoperative complications, occurring within 30 days after surgery (D30) and defined as all complications with Clavien-Dindo grade>2.
    Fréquence de patients avec complications postopératoires majeures, survenant dans les 30 jours suivant la chirurgie (J30) et définies comme étant toutes les complications de grade>2 selon la classification de Dindo- Clavien.
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 30 days after surgery
    dans les 30 jours suivant la chirurgie
    E.5.2Secondary end point(s)
    1. Efficacy:
    - Overall survival at 3 years (defined as the time from surgery to death from any cause)
    - Disease-free survival at 3 years (defined as the time from surgery to first documented progressive disease or death from any cause, whichever occurs first.
    - Frequency of patients with postoperative infections occurring within 30 days after surgery and defined according to the CDC definition (Appendix 1).
    - Frequency of patients with intraabdominal infections (including anastomotic fistula and intraabdominal abscess) within 30 days after surgery and defined according to the CDC definition (Appendix 2)
    - Number of hospitalization days. In the case of death, patients will be considered as hospitalized until D30

    2. Safety: frequency and type of side effects, particularly hyperglycemia and electrolyte disorders assessed by glycemia and an electrolyte panel within the first 24 postoperative hours, and wound healing assessed by clinical inspection at the D30 follow-up visit
    1- Efficacité :
    - Survie globale à 3 ans (délai entre la chirurgie et le décès, toutes causes confondues)
    - Survie sans maladie à 3 ans (délai entre la chirurgie et le 1er événement survenant parmi : le 1er signe de progression de la maladie ou le décès, quelle qu'en soit la cause)
    - Fréquence de patients avec infections postopératoires survenant dans les 30 jours suivant l'intervention chirurgicale et définies selon les définitions de la CDC.
    - Fréquence de patients avec infections intra-abdominales (y compris les fistules anastomotiques et les abcès intra-abdominaux) dans les 30 jours suivant la chirurgie (définition de la CDC)
    - Nombre de jours d'hospitalisation. En cas de décès, le patient sera considéré comme hospitalisé jusqu'à J30.

    2- Sécurité : fréquence et type d'effets secondaires, en particulier l'hyperglycémie et les troubles électrolytiques évalués par des prélèvements sanguins dans les 24 premières heures postopératoires, et cicatrisation des plaies évaluée par inspection clinique au suivi J30.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Efficacy:
    - overall survival: 3 years
    - disease-free survival: 3 years
    - frequency of patients with postoperative infections: 30 days
    - frequency of patients with intraabdominal infections: 30 days
    - number of hospitalization days: 30 days

    2. Safety:
    - frequency and type of side effects: 24 postoperative hours
    - wound healing : 30 days
    1. Efficacité:
    - survie globale: 3 ans
    - survie sans maladie: 3 ans
    - fréquence de patients avec infections postopératoires : 30 jours
    - fréquence de patients avec infections intra-abdominales: 30 jours
    - nombre de jours d'hospitalisation: 30 jours

    2. Sécurité:
    - fréquence et type d'effets secondaires: dans les 24 premières heures postopératoires
    - cicatrisation des plaies: 30 jours
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-03-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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