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    Clinical Trial Results:
    NEOADJUVANTE RADIOTHERAPIE MIT CETUXIMAB BEI PATIENT/INNEN MIT FORTGESCHRITTENEN TUMOREN DER KOPF-HALSREGION

    Summary
    EudraCT number
    		 2011-002195-16
    Trial protocol
    		 AT  
    Global end of trial date
    19 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Neorex
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währingergürtel 18-20, Vienna, Austria, 1090
    Public contact
    Matthias Zimmermann, Medical University of Vienna Department of Oral, Maxillary and Facial Surgery, 0043 14040042520, matthias.zimmermann@meduniwien.ac.at
    Scientific contact
    Matthias Zimmermann, Medical University of Vienna Department of Oral, Maxillary and Facial Surgery, 0043 4040042520, matthias.zimmermann@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Bestimmung des histopathologischen Regressionsgrades nach präoperativer kombinierter Radiotherapie mit Cetuximab
    Protection of trial subjects
    Schwerwiegende unerwünschte Ereignisse müssen dem Sponsor innerhalb von 24 Stunden telefonisch bzw. per Fax auf dem dafür vorgesehenen Formular für schwerwiegende unerwünschte Ereignisse gemeldet werden. Beurteilt der Sponsor auf der Basis der Einschätzung des jeweiligen Prüfarztes den Zusammenhang des Serious Adverse Event (SAE) mit Cetuximab als möglich oder wahrscheinlich, meldet er dieses als Verdachtsfall einer schwerwiegenden unerwünschten Arzneimittelwirkung innerhalb von 15 Tagen an das Bundesministerium für Gesundheit und Frauen. Ferner informiert der Sponsor die zuständige Ethikkommission über alle schwerwiegenden und unerwarteten Ereignisse, die im Rahmen der Studie auftreten. Die Beobachtungsperiode für unerwünschte Ereignisse beginnt mit der ersten Gabe von Cetuximab und endet mit der Visite zum Abschluss der Therapie. In der Follow-Up Phase besteht eine Meldepflicht für unerwünschte Ereignisse nur bei vermutetem Kausalzusammenhang mit der Studientherapie.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    39
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    39
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 prätherapeutische Diagnoseschritte: - klinische Untersuchung (Inspektion, Palpation) - Fotodokumentation - Labor - Lebensqualität ( - Biopsie (+ Biomarker) - ev. Panendoskopie - Staging CT / MRT, C/P, Sonographie, PET-CT - Tumortätowierung

    Pre-assignment period milestones
    Number of subjects started
    		 39
    Number of subjects completed
    		 39

    Period 1
    Period 1 title
    Behandlungsphase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    offenes Studiendesign

    Arms
    Arm title
    		 Neoadjuvant Cetuximab
    Arm description
    		 Loading Dose Cetuximab (400mg/m2) 6-8 Sitzungen (250mg/m2) Konkomitant Radiatio Tumorresektion in 15. Therapiewoche Follow Up für 5 Jahre alle 3 Monate
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cetuximab (Erbitux)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Loading Dose Cetuximab (400mg/m2) 6-8 Sitzungen (250mg/m2)

    Number of subjects in period 1
    		Neoadjuvant Cetuximab
    Started
    39
    Completed
    33
    Not completed
    6
         Protocol deviation
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Behandlungsphase
    Reporting group description
    		 -

    Reporting group values
    		 Behandlungsphase Total
    Number of subjects
    		 39 39
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 37 37
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 27 27

    End points

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    End points reporting groups
    Reporting group title
    Neoadjuvant Cetuximab
    Reporting group description
    		 Loading Dose Cetuximab (400mg/m2) 6-8 Sitzungen (250mg/m2) Konkomitant Radiatio Tumorresektion in 15. Therapiewoche Follow Up für 5 Jahre alle 3 Monate

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Loading Dose Cetuximab (400mg/m2) 6-8 Sitzungen (250mg/m2) Konkomitant Radiatio Tumorresektion in 15. Therapiewoche Follow Up für 5 Jahre alle 3 Monate

    Primary: Histopathologic Regression Rate

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    End point title
    		 Histopathologic Regression Rate
    End point description
    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
    End point type
    Primary
    End point timeframe
    Surgery date with histophatologic evaluation
    End point values
    		 Neoadjuvant Cetuximab Overall trial
    Number of subjects analysed
    39
    39
    Units: Regression rate
        Regressionsgrad 1
    5
    5
        Regressionsgrad 2
    2
    2
        Regressionsgrad 3
    1
    1
        Regressionsgrad 4
    9
    9
    Statistical analysis title
    		 Primary
    Statistical analysis description
    Loading Dose Cetuximab (400mg/m2) 6-8 Sitzungen (250mg/m2) Konkomitant Radiatio Tumorresektion in 15. Therapiewoche Follow Up für 5 Jahre alle 3 Monate
    Comparison groups
    Neoadjuvant Cetuximab v Overall trial
    Number of subjects included in analysis
    78
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 Deskriptive Statistik
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    19.05.2015
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Frequency threshold for reporting non-serious adverse events: 2.7%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no serious adverse events recorded for the results.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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