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    Summary
    EudraCT Number:2010-019748-38
    Sponsor's Protocol Code Number:UniHD-2010-11-40-1001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-29
    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 ConcernedGermany - PEI
    A.2EudraCT number2010-019748-38
    A.3Full title of the trial
    Hautveränderungen bei Patienten mit Kopf- und Halstumor unter kombinierter RadioImmuno-(chemo)-therapie mit Erbitux®
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nebenwirkungen unter kombinierter Strahlentherapie, Antikörpertherapie mit Erbitux® (und ggf. Chemotherapie) bei Patienten mit Kopf- und Halstumoren
    A.3.2Name or abbreviated title of the trial where available
    HICARE-Trial
    A.4.1Sponsor's protocol code numberUniHD-2010-11-40-1001
    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 SponsorUniversity of Heidelberg
    B.1.3.4CountryGermany
    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 organisationUniversity of Heidelberg
    B.5.2Functional name of contact pointProf. Dr. Dr. Jürgen Debus
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 400
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 6221 56-8201
    B.5.5Fax number+49 6221 56-5353
    B.5.6E-mailJuergen.Debus@med.uni-heidelberg.de
    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
    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.3.4Pharmaceutical 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 205923564
    D.3.9.3Other descriptive nameCetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    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 typeMonoclonal chimeric antibody
    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
    Locally advanced, non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).
    Lokal fortgeschrittenes, nicht metastasiertes Plattenepithelkarzinom der Kopf-Hals Region
    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
    Rate of radiation dermatitis Grade 3/4
    E.2.2Secondary objectives of the trial
    - Rate of radiation dermatitis Grade 1/2
    - Rate of cetuximab-mediated acneiform rash Grade 1-4
    - Rate of cetuximab-mediated rhagades Grade 1-4
    - Rate of cetuximab-mediated nail changes Grade 1-4
    - Objective response rate (ORR)
    - Locoregional control (LRC)
    - Progression free survival (PFS)
    - Overall survival (OS)
    - Safety profile
    - Median dose density of radiation
    - Safety profile of applied radiation protocol
    - Quality of Life (QoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed, locally advanced (stage III, IVA or IVB) non-metastatic squamous-cell carcinoma of the oral cavity, oro- or hypopharynx and larynx
    - ECOG Performance Status of 0-2
    - ≥ 18 years of age
    - Life expectancy of at least 6 months.
    - Adequate bone marrow, liver and renal function (according to SmPC of Cetuximab) based on laboratory assessments raised within 7 days prior to start of study treatment.
    - Signed and dated informed consent before the start of specific protocol procedures.
    - Women of childbearing potential must have had a negative serum or urine beta-HCG pregnancy test within 7 days prior to the first administration of study treatment or must have a documented condition that prohibits pregnancy (e.g. post-menopausal; hysterectomy).
    - Patients enrolled in this trial must be willing to use effective birth control measures during the course of the trial and the subsequent 2 months
    E.4Principal exclusion criteria
    - Nasopharyngeal carcinoma
    - Distant metastases
    - Previous radiotherapy for carcinoma of the head and neck
    - Participation in other clinical trial (according to the German Drug Law (Arzneimittelgesetz - AMG) within 30 days prior to start of study treatment
    - Previous exposure to epidermal growth factor (EGFR) targeted therapy
    - Known hypersensitive reaction to any of the components of study treatments
    - Previous or concurrent cancer within 5 years prior to study entry that is distinct in primary site or histology except adequately treated basal cell carcinoma or preinvasive cervical carcinoma.
    - Pregnant or breast-feeding patients
    - Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results as judged by the investigator
    - Any condition that is unstable or could jeopardise the safety of the patient and their compliance in the study as judged by the investigator
    - Incapacity to consent or limited capacity to consent
    E.5 End points
    E.5.1Primary end point(s)
    To assess acute radiation dermatitis of combined radioimmuno(chemo)therapy with Cetuximab in patients with locally advanced, non-metastatic squamous cell carcinoma of the head and neck (LASCCHN).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ongoing (during the entire treatment and follow up) and after end of the trial (including FU)
    E.5.2Secondary end point(s)
    - Rate of radiation dermatitis Grade 1/2
    - Rate of cetuximab-mediated acneiform rash Grade 1-4
    - Rate of cetuximab-mediated rhagades Grade 1-4
    - Rate of cetuximab-mediated nail changes Grade 1-4
    - Objective response rate (ORR)
    - Locoregional control (LRC)
    - Progression free survival (PFS)
    - Overall survival (OS)
    - Safety profile
    - Median dose density of radiation
    - Safety profile of applied radiation protocol
    - Quality of Life (QoL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) Ongoing (during the entire treatment and follow up):
    - Rate of radiation dermatitis Grade 1/2
    - Rate of cetuximab-mediated acneiform rash Grade 1-4
    - Rate of cetuximab-mediated rhagades Grade 1-4
    - Rate of cetuximab-mediated nail changes Grade 1-4
    b) End of the trial (including FU)
    - Objective response rate (ORR)
    - Locoregional control (LRC)
    - Progression free survival (PFS)
    - Overall survival (OS)- Safety profile
    - Median dose density of radiation
    - Safety profile of applied radiation protocol
    - Quality of Life (QoL)
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned40
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    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)
    Post-trial care: normal treatment of that condition
    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 Decision2011-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-04
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