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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-023035-42
    Sponsor's Protocol Code Number:Protocole FEDEGYN 02 / 0410
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2010-12-09
    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 number2010-023035-42
    A.3Full title of the trial
    Etude randomisée de phase III évaluant la Chimiothérapie Hyperthermique Intra Péritonéale dans le traitement du cancer de l’Ovaire en Récidive.
    A.3.2Name or abbreviated title of the trial where available
    CHIPOR
    A.4.1Sponsor's protocol code numberProtocole FEDEGYN 02 / 0410
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFédération Nationale des Centres de Lutte Contre le Cancer
    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 organisation
    B.5.2Functional name of contact point
    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 Cisplatine
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATIN
    D.3.9.1CAS number 15663271
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer épithélial de l’ovaire : récidive intrapéritonéale résécable
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10033160
    E.1.2Term Ovarian epithelial cancer recurrent
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Améliorer la survie globale de 12 mois pour les patientes du bras CHIP comparées aux patientes du bras non CHIP.
    E.2.2Secondary objectives of the trial
    - Evaluer la survie sans récidive.
    - Evaluer la survie sans récidive.
    - Evaluer la qualité de vie et la douleur : questionnaires QLQ C30 et FACT O (« functional assessment of cancer therapy for ovarian cancer ») et l’Echelle Visuelle Analogique (EVA).
    - Evaluer les toxicités au traitement (CTC-AE v4.0) dont les toxicités rénales.
    - Evaluer la morbidité
    - Etude médico économique : Recueil des données sociodémographiques et coûts liés à la prise en charge des patientes.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Etude pharmacocinétique : comparaison des techniques CHIP utilisées (à ventre ouvert et à ventre fermé) en analysant les concentrations de platine aux niveaux péritonéal et plasmatique.
    E.3Principal inclusion criteria
    1. Patiente âgée de ≥ 18 ans,
    2. Performans Status OMS < 2,
    3. Initialement traitée pour un cancer du revêtement épithélial ovarien,
    4. Patiente présentant une récidive intra péritonéale (à plus de 6 mois de la fin du traitement initial) résécable avec reliquat infraclinique sans métastase à distance (Sont autorisés: l’épanchement pleural métastatique isolé qui doit être sensible à la chimiothérapie de deuxième ligne à base de platine, une atteinte ganglionnaire rétropéritonéale ou inguinale, extirpable),
    5. Chimiothérapie pré opératoire de deuxième ligne à base de platine : soit par carboplatine-paclitaxel, soit par carboplatine-caelix,
    6. Résécabilité complète,
    7. Le délai entre la dernière cure de chimiothérapie de deuxième ligne et la chirurgie doit être compris entre 5 et 8 semaines,
    8. Pas d’insuffisance hépatique (bilirubine ≤ 1,5 fois la normale), ASAT et ALAT ≤ 3 fois la limite supérieure de la normale,
    9. Absence d’insuffisance rénale (créatinine ≤ 1,5 fois la normale, clairance de la creatinine >60 ml/mn, selon la méthode MDRD.
    10. Fonction hématologique : PNN ≥ 1,5x109/L, plaquettes ≥ 100x109/L,
    11. Absence de contre indication à une anesthésie générale pour une chirurgie lourde,
    12. Information de la patiente et signature du consentement éclairé obtenu avant le début de toute procédure spécifique à l’étude,
    13. Affiliation à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    1) Patiente mineure (<18 ans),
    2) Antécédents de cancer (sauf un carcinome baso-cellulaire cutané ou un carcinome in situ du col utérin) ayant récidivé dans les 5 années précédant l'entrée dans l'essai,
    3) Hypersensibilité reconnue au Cisplatine,
    4) Localisations tumorales métastatique décelables,
    5) Utilisation de traitements anti-angiogéniques,
    6) Affection coexistante grave mettant le pronostic vital en jeu,
    7) La prévision de plus de deux résections digestives segmentaires de façon concomitante à la CHIP,
    8) Progression des dimensions de la récidive sous chimiothérapie de deuxième ligne,
    9) Récidive de moins de 6 mois après la fin du traitement initial,
    10) Tumeur ovarienne d’histologie autre que tumeur du revêtement épithélial,
    11) Infection non contrôlée,
    12) Impossibilité géographique ou psychologique d’effectuer le suivi prévu dans l’essai,
    13) Pathologie cardio-respiratoire contre indiquant une hyper hydratation, devant être mise en place pour la CHIP,
    14) Patiente ayant déjà été traitée par chimiohyperthermie pour le cancer ovarien
    15) Personne privée de liberté ou sous tutelle, ou non affiliée à un régime de sécurité sociale.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement pour l’évaluation de la survie globale sera la date de la survenue du décès quelle qu’en soit la cause.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Etude médico économique
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Chirurgie complète
    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 concerned25
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    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 state444
    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 Decision2011-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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