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    The EU Clinical Trials Register currently displays   37743   clinical trials with a EudraCT protocol, of which   6185   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-002195-16
    Sponsor's Protocol Code Number:
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-27
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-002195-16
    A.3Full title of the trial
    NEOADJUVANTE RADIOTHERAPIE MIT CETUXIMAB BEI PATIENT/INNEN MIT FORTGESCHRITTENEN TUMOREN DER KOPF-HALSREGION
    A.3.2Name or abbreviated title of the trial where available
    NEOREX
    A.4.1Sponsor's protocol code number
    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 SponsorMUW, Klinik für Mund-, Kiefer-und Gesichtschirurgie
    B.1.3.4CountryAustria
    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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA-Darmstadt
    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.3.2Product code EMD27186
    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 INNCetuximab
    D.3.9.1CAS number 205923-56-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5mg/ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typemonoklonaler antikörper
    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
    FORTGESCHRITTENE PLATTENEPITHELKARZINOME DER KOPF-/HALSREGION
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Bestimmung des histopathologischen Regressionsgrades nach präoperativer kombinierter Radiotherapie mit Cetuximab
    E.2.2Secondary objectives of the trial
    - Klinische Ansprechrate nach präoperativer kombinierter Radiotherapie mit Cetuximab vor OP
    - Toxizität des Therapieschemas
    - Rezidivfreies Überleben und Gesamtüberleben nach 2 Jahren

    - Korrelation der Cetuximab-induzierten Akne mit dem histo-pathologischen Ansprechen (Regressionsgrad) und dem klinischen Ansprechen
    - Biomarkeranalysen aus prätherapeutischen Tumorgewebeproben und dem Operationsmaterial (aus Paraffinschnitten, auch mittels der TMA („Tissue Microarray“ Technik). Bestimmung der Expression insbesondere von:

    • EGFR (Typ-I bis IV) und phospho-EGFR
    • HPV16 und p 16
    • TP53-wt und mutiert
    • MAPK und phospho MAPK
    • AKT und phospho- AKT
    • IGFR, c- MET, K-RAS
    • Proliferationsmarker
    • Proteomananalysen aus Paraffinschnitten

    - Optional: Funktionale Bildgebung mit 18F-MISO-PET-CT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologisch gesichertes Plattenepithelkarzinom der Kopf-Halsregion (Mundhöhle, Oropharynx) im Stadium III-IV.
    1. Allgemeinzustand ECOG 0-2

    2. Eindimensional messbarer Tumor

    3. Männliche und weibliche Patienten im Alter von 18 – 70 Jahren

    4. Schriftliches Einverständnis zur Teilnahme an der Studie
    E.4Principal exclusion criteria
    1. Sekundäre Neoplasie

    2. Generalisierung im Rahmen der Grunderkrankung

    3. Floride Infektion

    4. Eingeschränkte Geschäftsfähigkeit (im juristischen Sinne)

    5. Mangelnde Kooperationsbereitschaft des Patienten

    6. Schwangerschaft und Stillzeit (bei gebärfähigen Frauen sind kontrazeptive Maßnahmen zu ergreifen)

    7. Teilnahme an einer anderen Studie innerhalb der letzten 30 Tage

    8. Komorbiditäten, welche eine Operation (radikale Resektion) oder eine präoperative kombinierte Radiotherapie mit Cetuximab nicht zulassen
    E.5 End points
    E.5.1Primary end point(s)
    Anhand des radiologischen Befundes und der klinischen Untersuchung wird das Ansprechen (Komplette
    Remission versus kein Ansprechen) evaluiert. Die radiologische Beurteilung des Tumoransprechens erfolgt
    wahlweise anhand des CT oder MRI Befundes, in jedem Fall anhand desselben bildgebenden Verfahrens, das
    auch für den Ausgangsbefund verwendet wurde.
    Nach Aufarbeitung und histologischer Auswertung der Tumorresektate wird eine histopathologische
    Unterteilung der Regressionsgrade entsprechend folgender Unterteilung (Klassifikation nach Braun et al, 1989)
    vorgenommen:
    Regressionsgrad 1: Responder – keine vitalen Tumorzellen fassbar
    Regressionsgrad 2: Partial Responder – minimale Tumorzellnester (< 5%) vorhanden
    Regressionsgrad 3: Non-responder – 5-50% vitale Tumorzellen vorhanden
    Regressionsgrad 4: Non-Responder – mehr als 50% vitale Tumorzellen vorhanden
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 No
    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 months0
    E.8.9.1In the Member State concerned days0
    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) No
    F.1.2.1Number of subjects for this age range: 60
    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 state60
    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 Decision2012-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-19
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