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    Summary
    EudraCT Number:2011-000408-17
    Sponsor's Protocol Code Number:VA 2011/01
    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:2011-04-07
    Trial results View 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 number2011-000408-17
    A.3Full title of the trial
    Etude de phase II randomisée évaluant la chimioradiothérapie (RT + cisplatine vs. RT + cisplatine + gemcitabine) comme traitement conservateur des cancers infiltrants de vessie opérables d’emblée : Etude GETUG V04
    A.3.2Name or abbreviated title of the trial where available
    GETUG V04
    A.4.1Sponsor's protocol code numberVA 2011/01
    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 SponsorCRLC Val d’Aurelle – Paul Lamarque
    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 organisationCRLC Val d’Aurelle - Paul Lamarque
    B.5.2Functional name of contact pointDr Jean-Pierre BLEUSE
    B.5.3 Address:
    B.5.3.1Street Address208, rue des Apothicaires
    B.5.3.2Town/ cityMontpellier Cedex 5
    B.5.3.3Post code34298
    B.5.3.4CountryFrance
    B.5.4Telephone number3304 67 61 23 44 / 31 02
    B.5.5Fax number33 04 67 61 30 23
    B.5.6E-mailJean-Pierre.Bleuse@valdorel.fnclcc.fr
    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 holderACCORD HEALTHCARE France 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 No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATIN
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 2
    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 No
    D.2.1.1.1Trade name GEMZAR
    D.2.1.1.2Name of the Marketing Authorisation holderLILLY FRANCE S.A.S.
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancers infiltrants de vessie opérables d’emblée.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer la survie sans maladie à 2 ans (DFS) de l’association radiothérapie + cisplatine + gemcitabine.
    E.2.2Secondary objectives of the trial
    - Toxicités aiguës et tardives (NCI CTC v4.0)
    - Qualité de vie fonctionnelle (questionnaire adapté à la vessie EORTC QLQ-BLM30)
    - Qualité de vie rapportée à l’âge (questionnaires spécifiques oncogériatriques EORTC QLQ-ELD15)
    - Corréler la toxicité tardive avec le taux d’apoptose lymphocytaire radioinduit CD8 in vitro (étude biologique optionnelle)
    - Survie globale.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PREDICTION DES TOXICITES TARDIVES RADIO-INDUITES PAR LE TAUX D’APOPTOSE LYMPHOCYTAIRE CD8 RADIO-INDUITE.

    Il est proposé dans cette étude translationnelle de mesurer prospectivement et avant tout traitement de radiothérapie, le taux d’apoptose lymphocytaire CD8 radio-induit.

    Une corrélation entre le taux bas d’apoptose lymphocytaire et la sévérité des toxicités tardives sera recherchée afin de confirmer la puissance prédictive de nos tests biologiques sur la séquelle radio-induite.
    E.3Principal inclusion criteria
    - Carcinome urothélial infiltrant la musculeuse (d’emblée ou après évolution d’une tumeur superficielle), de stade pT2-pT3 sans atteinte ganglionnaire (N0) pour lequel une résection macroscopique optimale a été réalisée
    - La preuve du caractère invasif au niveau de la musculeuse doit être apportée par une résection transurétrale effectuée sous anesthésie moins de 8 semaines auparavant ou à défaut sur des biopsies superficielles et une imagerie formelle. Des biopsies endovésicales à distance doivent également être réalisées
    - Age supérieur ou égal à 18 ans
    - Espérance de vie supérieure ou égale à 6 mois
    - Kanorfsky ≥ 70 % (OMS : 0, 1, 2)
    - Critères biologiques : polynucléaires neutrophiles ≥ 1500/mm3, Plaquettes ≥ 100 000/mm3, hémoglobine ≥ 10 g/dl, clairance de la créatinine > 60 ml/mn
    - Pas de métastases à distance
    - Contraception efficace chez les hommes et les femmes en âge de procréer maintenue pendant toute la durée du traitement et jusque 2 mois après la fin de la radiothérapie
    - Pas d’antécédent de radiothérapie ni de chimiothérapie à l'exception des instillations endovésicales
    - Pas de contre-indication à la chimiothérapie comportant du cisplatine avec ou sans gemcitabine
    - Pas de contre-indication à la radiothérapie
    - Information du patient et signature du consentement éclairé
    - Affiliation à un régime d’assurance sociale.
    E.4Principal exclusion criteria
    - Tumeur n'envahissant pas le muscle
    - Carcinome épidermoïde ou adénocarcinome
    - Métastases à distance ou atteinte ganglionnaire extrapelvienne
    - Antécédents digestifs graves (rectocolite hémorragique, diverticulose compliquée)
    - Antécédents carcinologiques à l'exception des tumeurs cutanées non mélaniques et carcinomes in situ du col de l'utérus préalablement traités
    - Patient déjà inclus dans un autre essai thérapeutique susceptible d’interférer avec la séquence thérapeutique proposée
    - Grossesse et allaitement
    - Incapacité légale ou capacité légale limitée. Conditions médicales ou psychologiques ne permettant au sujet de compléter l’étude ou de signer le consentement (art. L.1121-6, L.1121-7, L.1211-8, L1211-9).
    E.5 End points
    E.5.1Primary end point(s)
    Le délai de survie sans maladie (DFS) à 2 ans est calculé entre la date de randomisation et la date d’apparition du premier évènement selon: la récidive intravésicale (CIS ou infiltrant), l’évolution métastatique extravésicale (ganglionnaire, viscérale, osseuse) et le décès. Les délais jusqu’à la rechute pour les patients sans aucun événement (ni récidive locale, régionale, à distance, ni décès) seront censurés à la date des dernières nouvelles.
    E.5.2Secondary end point(s)
    - Survie globale : Le délai jusqu’au décès est défini par le délai entre la date de randomisation et la date du décès quelque soit la cause, sinon jusqu’à la date des dernières nouvelles.
    - Toxicités aiguës et tardives codées selon l’échelle NCI-CTC v4.0 : tous les patients sont évaluables sur le critère de toxicité dès la première fraction de radiothérapie. Les toxicités dans le champ d’irradiation et systémiques doivent être distinguées car d’étiologies différentes.
    - La Qualité de vie (EORTC) sera évaluée selon les questionnaires EORTC QLQC30 + QLQ-BLM30 et QLQ-ELD15.
    - Corrélation entre l’apoptose lymphocytaire et la sévérité des toxicités tardives (étude biologique optionnelle): en ce qui concerne l’évaluation des effets tardifs, tous les délais seront calculés à partir du premier jour (J1) du traitement par radiothérapie. Les incidences cumulées des complications en fonction des variables pronostiques seront estimées de manière non-paramétrique. L’analyse statistique principale prévoit une analyse multivariée par un modèle à risques compétitifs pour l’évaluation de l’impact du taux d’apoptose lymphocytaire CD8 radio-induite et sur la survenue de complications tardives en présence d’autres événements tels que la récidive ou le décès considérés comme risques compétitifs.
    Une analyse multivariée des courbes ROC sera réalisée afin d’évaluer la sensibilité et la spécificité du taux d’apoptose lymphocytaire CD8 radio-induite en sélectionnant les patients ayant au minimum 2 ans de recul pour pouvoir bien différencier la population ayant eu ou non une complication tardive.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Qualité de vie
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Radiothérapie + cisplatine
    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 concerned15
    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 years8
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 state109
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CRLC Val d’Aurelle et Institut de Recherche en Cancérologie de Montpellier
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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