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    Summary
    EudraCT Number:2006-003377-27
    Sponsor's Protocol Code Number:Sarcome 09/0603
    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:2006-08-04
    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 number2006-003377-27
    A.3Full title of the trial
    Etude Intergroupe (SFCE/GSF/GETO) OS2006 Zolédronate-Ostéosarcome
    Protocole de traitement des ostéosarcomes de l’enfant, de l’adolescent et de l’adulte comportant :
    - un essai randomisé
    - et des études biologiques
    A.3.2Name or abbreviated title of the trial where available
    OS 2006
    A.4.1Sponsor's protocol code numberSarcome 09/0603
    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 ZOMETA ®
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMA SAS
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameZOMETA ®
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNacide zolédronique
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4mg/5ml
    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
    Les biphosphonates sont des analogues synthétiques des pyrophosphates endogènes dont la fonction principale est d’inhiber la résorption osseuse. Leur utilisation s’est imposée depuis une dizaine d’années pour le traitement de l’ostéoporose, des pathologies ostéolytiques dans le traitement de l’hypercalcémie et, plus récemment, dans la prévention des complications des métastases osseuses.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10031291
    E.1.2Term Osteosarcoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l'efficacité de l’adjonction d’un traitement par Zometa® toutes les 4 semaines pendant 10 mois au traitement classique, associant chimiothérapie et chirurgie, sur la survie sans événement des malades adultes et enfants porteurs d’un ostéosarcome
    E.2.2Secondary objectives of the trial
    • Evaluer l’impact du Zometa®
    - sur la survie globale,
    - sur la réponse histologique à la chimiothérapie,
    - sur la tolérance du traitement immédiate et à long terme, en particulier la tolérance rénale, les complications orthopédiques, la croissance et la densité osseuse,
    - la qualité de vie.

    • Etudier de manière prospective, sur les échantillons biologiques collectés au diagnostic :
    - Les profils d’expression génétique des malades bons et mauvais répondeurs,
    - Les différences de profils d’expression en tissue-array des malades adultes et enfants,
    - La valeur pronostique de marqueurs de l’angiogénèse tels que le FGF et le VEGF,
    - L’expression d'antigènes tumoraux,
    - l’effet du Zometa® sur les populations lymphocytaires notamment 
    - L'étude des conséquences du traitement par biphosphonates sur le métabolisme osseux et la croissance.
    - L'impact de la pharmacogénétique de méthotrexate
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    études biologiques:
    1. Allélotypage des tumeurs
    2. Etude génomique
    3. Tissue array
    4. Facteurs angiogéniques
    5. Explorations immunologiques
    6. Résorption osseuse
    7. Pharmacogénétique
    E.3Principal inclusion criteria
    • Patient avec un ostéosarcome de haut grade prouvé histologiquement
    • Age égal ou inférieur à 50 ans
    • Ne présentant pas de contre-indication aux traitements envisagés
    • Non antérieurement traité par chimio ou radiothérapie pour cette tumeur ou un autre cancer
    • Ayant signé le consentement éclairé. Pour les mineurs non émancipés, l’autorisation sera donnée par les titulaires de l’autorité parentale. Cette autorisation peut être donnée par un seul des titulaires de l’autorité parentale si l’autre titulaire ne peut donner son autorisation dans les délais compatibles avec les exigences méthodologiques propres à la réalisation de la recherche. Les mineurs recevront l’information prévue adaptée à leur capacité de compréhension
    • Pour lequel un suivi à long terme est possible
    • et déclaré au centre d'enregistrement dès le consentement recueilli, au plus tard au 3ème jour de la première cure de chimiothérapie
    • Contraception efficace chez les femmes en âge de procréer
    • Affiliation à un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Ostéosarcomes de bas grade
    - Ostéosarcome à petites cellules (à traiter plutôt comme des tumeurs d’Ewing)
    - Ostéosarcome du maxillaire (en raison du risque d’ostéonécrose du maxillaire lié aux biphosphonates)
    - Ostéosarcome opéré d'emblée
    - Ostéosarcome polymétastatique avec métastases jugées a priori inopérables même après réduction sous chimiothérapie
    - Ostéosarcome extra-osseux
    - Maladie chronique incompatible avec la réalisation du protocole
    - Fraction de raccourcissement inférieur à 28% ou FEV<50% isotopique avant traitement pour les malades qui doivent être traités selon le protocole API-AI
    - Clearance de la créatinine calculée <70 ml/mn/1,73 m²
    - Bilirubine > 2 x valeur normale supérieure
    - Problème dentaire en cours ou récent (< 6 semaines) comprenant toute infection des dents ou de la mâchoire (mandibule et maxillaire), traumatisme dentaire, chirurgie dentaire ou stomatologique (extraction, implants)
    - Antécédent d'ostéonécrose du maxillaire ou de mise à nu de l'os ou de retard de cicatrisation après une intervention dentaire
    - Toute anomalie médicale incompatible avec les traitements prévus dans cette étude
    - Grossesse ou allaitement
    - Patient qui pour des raisons familiales, sociales, géographiques ou psychologiques ne pourra être suivi régulièrement
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement principal est la survie sans événement (EFS), définie par le délai entre la date de randomisation et le premier des événements suivants :
    • Décès (quelle qu’en soit la cause)
    • Rechute
    • Progression de la maladie
    • Seconde tumeur.
    L’EFS sera estimée selon la méthode de Kaplan-Meier.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned24
    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 years9
    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 Yes
    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) Yes
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 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 state470
    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 Decision2007-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-06
    P. End of Trial
    P.End of Trial StatusOngoing
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