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    Summary
    EudraCT Number:2014-004678-41
    Sponsor's Protocol Code Number:UC_0160/1406
    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:2016-02-23
    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 number2014-004678-41
    A.3Full title of the trial
    Etude prospective de phase II d’évaluation d’une prise en charge multimodale des métastases ganglionnaires inguinales des carcinomes épidermoïdes du pénis par lymphadénectomie bilatérale et chimiothérapie TIP (paclitaxel, ifosfamide et cisplatine).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.3.2Name or abbreviated title of the trial where available
    AFU-GETUG 25 - MEGACEP
    A.4.1Sponsor's protocol code numberUC_0160/1406
    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 SponsorUNICANCER
    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 supportInstitutionels
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointMuriel HABIBIAN
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number+33176 64 78 07
    B.5.5Fax number+33185 34 33 79
    B.5.6E-mailm-habiban@unicancer.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 PACLITAXEL
    D.2.1.1.2Name of the Marketing Authorisation holderARROW GENERIQUES
    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 Concentrate for 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Yes
    D.2.1.1.1Trade name IFOSFAMIDE
    D.2.1.1.2Name of the Marketing Authorisation holderEG LABO - Laboratoires EuroGenerics
    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 INNIFOSFAMIDE
    D.3.9.1CAS number 3778-73-2
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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: 3
    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 Concentrate for 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 INNCISPLATINE
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB09583MIG
    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.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
    Tumeur du pénis
    E.1.1.1Medical condition in easily understood language
    Tumeur du pénis
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10062064
    E.1.2Term Penis carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation du taux de survie sans récidive ganglionnaire locorégionale (inguinale et iliaque) chez des patients atteint d’un carcinome épidermoïde du pénis pN+ présentant des métastases ganglionnaires inguinales après un traitement associant une chimiothérapie TIP adjuvante ou néoadjuvante au curage ganglionnaire inguinal.
    E.2.2Secondary objectives of the trial
    • Evaluation du taux de réponses complètes à la chimiothérapie (stérilisation tumorale) à 24 mois pour les patients traités par chimiothérapie néo-adjuvante
    • Evaluation du taux de récidives métastatiques à 3 ans
    • Evaluation du taux de survie globale spécifique à 3 ans
    • Evaluation du taux de survie globale à 3 ans
    • Evaluation de la toxicité de la chimiothérapie
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    • Intérêt de la surveillance par dosage sanguin du SCC (Squamous Cell Carcinoma) et du Cyfra-21.
    • Recherche de marqueurs tissulaires pronostiques de la réponse au traitement et de la survie globale.
    • Intérêt et de la fiabilité du PET-scan pour le bilan d’extension ganglionnaire évaluées par la sensibilité et la spécificité du PET-scan.
    E.3Principal inclusion criteria
    1. Tumeur du pénis histologiquement prouvée quel que soit le traitement initial de la tumeur pénienne : chirurgie conservatrice ou amputation ou curiethérapie,
    2. Une ou des adénopathies palpées et mobiles (stade cN1 et cN2) et quel que soit le stade T,
    Ou
    si pas d'adénopathie inguinale palpée (cN0), tumeur à risque d'envahissement ganglionnaire ≥pT1b et / ou Grade 2,
    3. Atteinte ganglionnaire métastatique
    4. Patients M0 ou Mx (par imagerie),
    5. Age≥ ou >18 ans,
    6. ECOG 0-1,
    7. Leucocytes ≥ 1.5 G/L,
    8. Hémoglobine ≥ 9 g/dL,
    9. Plaquettes ≥100 000/mm3,
    10. Calcémie et kaliémie normales,
    11. Fonction hépatique : ASAT et ALAT ≤ 1.5 LNS ; bilirubine totale ≤ 1.5 LNS (≤ 3 x LNS en cas de maladie de Gilbert); PAL < 2 LNS,
    12. Fonction rénale : Clairance de la créatinine ≥ 60 mL/mn (calculée par la méthode MDRD),
    13. FEVG > 50%,
    14. Patients ayant reçu et lu la note d’information et signé le consentement,
    15. Patients en âge de procréer acceptants d’utiliser deux méthodes de contraception (une pour le patient et une pour la partenaire) pendant toute la durée de l’étude et pendant 6 mois après la dernière administration du traitement,
    16. Patients capables de se conformer aux exigences du protocole (visites prévues, plan de traitement, examens cliniques, paracliniques et biologiques et toutes autres procédures prévues au protocole),
    17. Patients bénéficiant d’un régime de sécurité sociale.
    E.4Principal exclusion criteria
    1. Une ou des adénopathies inguinales fixées (patients cN3)
    2. Une ou des adénopathies iliaques (y compris par imagerie) (patients cN3)
    3. Patients pN3
    4. Chimiothérapie antérieure pour le carcinome épidermoïde du pénis,
    5. Contre-indication à la chimiothérapie ou hypersensibilité connue au cisplatine, à l’ifosfamide ou au paclitaxel,
    6. Patients traités par phénytoïne,
    7. Patients présentant une pathologie cardio-respiratoire contre-indiquant l’hyperhydratation,
    8. Antécédents de cancer dans les 5 ans précédant l’inclusion dans l’essai autre qu’un baso-cellulaire cutané,
    9. Patient ayant reçu un vaccin vivant atténué dans les 30 jours précédant l’inclusion,
    10. Patients déjà inclus dans un autre essai thérapeutique ou ayant reçu un traitement expérimental dans les 30 jours précédant l’inclusion dans l’essai,
    11. Patients privés de leur liberté ou sous protection judiciaire y compris sous tutelle,
    12. Toute évidence, selon l’investigateur, d’une maladie systémique sévère ou non contrôlée ou toute autre maladie chronique ou aigue qui serait incompatible avec la participation du patient à cet essai,
    13. Patients immunodéficients y compris avec une séropositivité connue pour le virus de l'immunodéficience humaine (VIH),
    14. Patients présentant une altération mentale qui empêcherait la compréhension du protocole ou présentant un état psychologique, des conditions familiales, sociologiques ou géographiques qui ne permettraient pas la compliance au protocole et au suivi prévu ou toute condition qui, selon l’investigateur, empêcherait la participation du patient à l’essai. Ces conditions doivent être évaluées avant l’inclusion des patients.
    E.5 End points
    E.5.1Primary end point(s)
    Taux de survie sans récidive ganglionnaire locorégionale à 24 mois évaluée par échographie inguinale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    _
    E.5.2Secondary end point(s)
    • Taux de réponse complète définie par une absence de tumeur résiduelle (stérilisation tumorale) sur la pièce du curage ganglionnaire après la chimiothérapie néo-adjuvante en cas de cytoponction ganglionnaire positive avant la chimiothérapie
    • MFS à 3 ans
    • OS spécifique à 3 ans
    • Survie globale à 3 ans
    • Taux de toxicité de la chimiothérapie sera évaluée selon les CTC-AE V4.03
    E.5.2.1Timepoint(s) of evaluation of this end point
    _
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    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.1.2.1Number of subjects for this age range: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    F.2 Gender
    F.2.1Female No
    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 state37
    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 Decision2016-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-05
    P. End of Trial
    P.End of Trial StatusOngoing
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