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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2015-001928-29
    Sponsor's Protocol Code Number:GORTEC2015-02
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-23
    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 number2015-001928-29
    A.3Full title of the trial
    Phase II randomized trial comparating two concomitant administration of radiotherapy with cisplatin in patients with not operated or inoperable squamous cell carcinoma of the head and neck or with recurrence high-risk in adjuvant postoperative treatment.
    Étude de phase II randomisée comparant deux schémas d’administration du Cisplatine concomitamment à la radiothérapie en traitement exclusif des carcinomes épidermoïdes de la tête et du cou non opérés ou non opérables, ou en traitement adjuvant postopératoire des formes à haut risque de récidive.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two concomitant administration of radiotherapy with cisplatin in standard infusion (1 time every 21 days) or fractional infusion ( 4 times every 21 days)
    Comparaison de deux schémas d'administration du Cisplatine concomitamment à la radiothérapie soit une perfusion standard (1 fois tous les 21 jours) soit une perfusion fractionnée (4 fois tous les 21 jours)
    A.3.2Name or abbreviated title of the trial where available
    CisFRad
    A.4.1Sponsor's protocol code numberGORTEC2015-02
    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 SponsorGORTEC
    B.1.3.4CountrySwitzerland
    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 supportGORTEC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGORTEC
    B.5.2Functional name of contact pointMarie-Hélène GIRARD CALAIS
    B.5.3 Address:
    B.5.3.1Street AddressCentre Henry Kaplan-CHU Bretonneau 2 Bd Tonnellé
    B.5.3.2Town/ cityTours cedex 1
    B.5.3.3Post code37044
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)2 47 47 91 21
    B.5.5Fax number33(0)2 34 38 94 11
    B.5.6E-mailrc.corad@chu-tours.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 Accord
    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.3.1Product nameCISPLATINE
    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 INNCISPLATINE
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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 RoleComparator
    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 ACCORD
    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.3.1Product nameCISPLATINE
    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 INNCISPLATINE
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    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
    carcinomes épidermoïdes de la tête et du cou non opérés ou non opérables, ou en traitement adjuvant postopératoire des formes à haut risque de récidive.
    E.1.1.1Medical condition in easily understood language
    carcinomes épidermoïdes de la tête et du cou non opérés ou non opérables
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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
    Comparer la dose cumulée de Cisplatine administrée concomitamment à la radiothérapie dans le bras A de référence (Cisplatine 100 mg/m2 J1 tous les 21 jours) et dans le bras B expérimental (Cisplatine fractionné 25 mg/m2/J J1 à J4 tous les 21 jours).
    E.2.2Secondary objectives of the trial
    - Comparer les profils de toxicités (NCI-CTC-AE 4.03)
    - Comparer les profils pharmacocinétiques du Cisplatine
    - Comparer les doses administrées par radiothérapie et la durée de l’irradiation
    - Evaluer l’intérêt diagnostique et pronostique du Neutrophil gelatinase-associated lipocalin (NGAL)
    - Comparer le taux d’échec loco-régional 3 mois après la fin du traitement
    - Comparer la survie sans progression et la survie globale 3 ans après la fin du traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Les patients ayant:
    - Carcinome épidermoïde des voies aérodigestives supérieures de stade III ou IV : cavité buccale, oropharynx, larynx ou hypopharynx.
    - Patient non opéré et/ou non opérable pour des raisons de non extirpabilité, d’extension loco-régionale, d’état général ou de condition médicale
    Ou
    Patient opéré dans les 8 semaines précédant la radiothérapie avec un haut risque de récidive : marges chirurgicales non satisfaisantes (R1) et/ou envahissement ganglionnaire avec rupture capsulaire.
    - Index d’activité selon l’OMS ≤ 2
    - Age ≤ 70 ans
    - Fraction d’éjection ventriculaire gauche conservée > 50%
    - Fonction rénale permettant l’administration du Cisplatine : clairance de la créatinine > 60 ml/min (formule de Cockroft)
    - Fonction hématologique permettant l’administration d’une CT : PNN> 1500, Pl > 100000, Hb > 9g
    - Fonction hépatique satisfaisante : SGOT et SGPT < 3N ; Bilirubine totale < 20 µmol/l ; INR < 1,5 ; albumine > 30 g/l
    - Soins stomatologiques adaptés
    - Signature du consentement éclairé
    - Indication d’irradiation cervicale bilatérale
    - Les femmes et les hommes en âge de procréer doivent avoir accepté une contraception médicalement efficace pendant la durée du traitement et au moins 6 mois après l’arrêt du traitement à l’étude. Si une grossesse est déclarée par une patiente ou la partenaire d’un patient, elle doit être suivie pour connaître l’évolution de la grossesse.
    E.4Principal exclusion criteria
    - Cancers du nasopharynx, des sinus ou des cavités nasales
    - Histologie autre qu’épidermoïde
    - Présence de métastases à distance
    - Chimiothérapie systémique antérieure (néoadjuvante)
    - Autres thérapies anticancéreuses concomitantes
    - Présence d’une infection nécessitant le recours aux antibiotiques par voie IV incluant tuberculose et infection par VIH
    - Insuffisance coronarienne, arythmie ou insuffisance cardiaque incontrôlées ou symptomatiques
    - Hypertension artérielle non contrôlée
    - Neuropathie périphérique grade > 1
    - Vaccination contre la fièvre jaune et phénytoïne récente ou prévue
    - Antécédents de cancer dans les 5 années précédant l'entrée dans l'essai autre qu'un baso-cellulaire cutané ou un épithélioma in situ du col utérin
    - Femme enceinte, susceptible de l’être ou en cours d'allaitement
    - Personnes privées de liberté, sous tutelle ou curatelle
    - Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques
    - Indication de radiothérapie cervicale unilatérale
    E.5 End points
    E.5.1Primary end point(s)
    Dose cumulée de Cisplatine administrée dans le bras A standard et dans le bras B fractionné
    E.5.1.1Timepoint(s) of evaluation of this end point
    Des prélèvements sanguins seront réalisés à chaque cycle aux temps 0, 90, 180, 210, 270, 360 et 420 minutes après le début de la perfusion dans le bras A et aux temps 0, 30, 45, 75, 135, 225 et 285 minutes après le début de la perfusion pour le bras B pour le dosage du platine par spectrométrie d’absorption atomique et émission de flamme.

    Une détermination de NGAL urinaire (marqueur de toxicité rénale) sera réalisée à chaque cure sur un prélèvement d’urine 24 h après l’administration du platine dans le bras standard, et 24 h après la dernière perfusion de platine dans le bras fractionné.
    E.5.2Secondary end point(s)
    - fréquence des toxicités (NCI-CTC-AE 4.03)
    - profil pharmacocinétique du Cisplatine
    - valeurs de NGAL
    - doses administrées de radiothérapie
    - durée de l’irradiation
    - Taux d’échec loco-régional 3 mois après la fin du traitement
    - survie sans progression et survie globale 3 ans après la fin du traitement
    E.5.2.1Timepoint(s) of evaluation of this end point
    Une surveillance clinique sera faite tous les 3 mois pendant 2 ans, puis tous les 6 mois. Un scanner et/ou IRM ORL, scanner thoracique sera fait à 3 mois, 15 mois et 36 mois après la fin du traitement.
    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 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 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 No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 92
    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 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 state92
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 92
    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 Decision2015-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-10
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