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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2006-006970-45
    Sponsor's Protocol Code Number:2006.420/13
    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:2007-10-12
    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 number2006-006970-45
    A.3Full title of the trial
    EVALUATION DE L’ASSOCIATION RADIOTHERAPIE DE CONFORMATION ET CHEMOEMBOLISATION INTRA-ARTERIELLE HEPATIQUE EN NEOADJUVANT DE LA RESECTION CHIRURGICALE DES CARCINOMES HEPATOCELLULAIRES DE GRANDE TAILLE
    A.3.2Name or abbreviated title of the trial where available
    RTF2
    A.4.1Sponsor's protocol code number2006.420/13
    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 SponsorHospices Civils de Lyon
    B.1.3.4CountryFrance, Metropolitan
    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.2.5The 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 nameDOXORUBICINE
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN
    D.3.9.1CAS number 23214928
    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 Information not present in EudraCT
    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
    Hepatocellular carcinoma respectable
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019830
    E.1.2Term Hepatocellular carcinoma resectable
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Le but de l’étude pilote RTF-2 est de montrer que la combinaison de la TACE hypersélective (doxorubicine) et de RTC délivrant de fortes doses sur le lit tumoral (45-57 Gy en fractions de 3 Gy) en pré-résection des CHC de grande taille (5 à 9 cm) développés sur cirrhose hépatique compensée (Child-Pugh A), est capable d’engendrer une nécrose tumorale totale dans au moins 25% des cas, et sans effet indésirable grave.
    E.2.2Secondary objectives of the trial
    • L'efficacité du traitement néo-adjuvant associant TACE + RTC d’après la réponse tumorale mesurée lors du contrôle scannographique pré-chirurgical réalisé 1 mois
    • Réponse tumorale complète sur des critères radiologiques d’échographie de contraste sur l’examen réalisé 1 mois après la fin de l’irradiation
    • Tolérance au traitement .
    • Morbidité/mortalité chirurgicale .
    • Survie sans récidive en post-chirurgie (5 ans).
    • Survie globale per traitement.
    • Survie globale en intention de traiter.
    • Evolution du taux d’α-fœtoprotéine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients des 2 sexes, âgés de 18 à 75 ans inclus, répondant aux critères suivants:
    • CHC diagnostiqué selon les recommandations de la conférence de consensus européenne [Bruix 2001], c’est-à-dire dans le cadre de cette étude : 1 nodule compris entre 5 et 9 cm, avec prise de contraste en phase artérielle tardive sur deux examens différents parmi l’échographie de contraste, le scanner spiralé et l’IRM, ou bien un seul examen positif avec un taux d’α-fœtoprotéine > 400 ng/mL, ou bien preuve cytologique et/ou histologique,
    • Patient jugé comme opérable et récusé pour la transplantation hépatique,
    • Absence de grossesse,
    • Bon état général défini par un index de Karnofsky >50%
    • Cirrhose sous-jacente avec score de Child-Pugh A, quelle que soit l'étiologie (virus des hépatites B ou C, alcool, hémochromatose,...),
    • Patients ayant donné leur consentement écrit.
    • Toute personne se prêtant à la recherche biomédicale doit être affiliée à un régime de sécurité sociale (décret n° 2006-477 du 26 avril 2006)
    E.4Principal exclusion criteria
    • Patient ayant bénéficié d’un traitement anti-néoplasique dans le mois précédent l’inclusion,
    • Femme en âge de procréer ne suivant pas de contraception efficace
    • Grossesse
    • Allaitement
    • Hypersensibilité aux anthracyclines
    • Cardiopathie aux anthracyclines
    • Insuffisance cardiaque : fraction d’éjection (< 50%) évaluée par échographie cardiaque dans le mois précédant la TACE
    • Insuffisance médullaire
    • Doses cumulées maximales atteintes par une autre anthracycline
    • Thrombose portale tronculaire ou lobaire, recherchée par l’examen tomodensitométrique du foie et l’échographie de contraste
    • Antécédent d’irradiation sur le foie ou les organes de voisinage dont les champs incluaient le foie
    • Cirrhose décompensée avec score de Child-Pugh B ou C (Annexe 5)
    • Affections médico-chirurgicales évolutives non stabilisées ou donnant une espérance de vie < 2 ans
    • Carcinome hépatocellulaire survenant sur foie transplanté
    • Patient non susceptible de s’astreindre à une surveillance protocolaire au long cours
    • Hypersensibilité au iobitridol ou à l'un des excipients
    • Antécédent de réaction immédiate majeure ou cutanée retardée à l'injection de Xenetix (iobitridol)
    • Thyréotoxicose manifeste
    • Goitre volumineux et multinodulaire chez le sujet âgé de plus de 45 ans
    • Vaccination anti-amarile, ou toute autre vaccination avec un vaccin vivant atténué, datant de moins de 6 mois
    E.5 End points
    E.5.1Primary end point(s)
    Réponse tumorale complète sur des critères histologiques à partir de la pièce opératoire : nécrose de la totalité de la tumeur appréciée par examen anatomopathologique de la pièce de tumorectomie ou d’hépatectomie. Des prélèvements d’épaisseur centimétrique seront réalisés sur l’ensemble de la zone tumorale, et seront recherchés les caractères suivants : résidus tumoraux, aspect morphologique des lésions tumorales et du tissu hépatique péritumoral irradiés. Une grille de lecture sera réalisée et une relecture centralisée de toutes les lames sera assurée.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    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.8.5The 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 months5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    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 Decision2007-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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