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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   43866   clinical trials with a EudraCT protocol, of which   7287   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:2005-000355-15
    Sponsor's Protocol Code Number:KKSH-19
    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:2005-03-16
    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 number2005-000355-15
    A.3Full title of the trial
    Phase I/II-study of hyperfractionated-accelerated radiation therapy (HART) plus cetuximab (CET) plus cisplatin (CIS) chemotherapy in locally advanced inoperable squamous cell cancers of head and neck.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical Phase I/II-study of radiation therapy (HART(hyperfractionated-accelerated radiation)) plus chemotherapy (cetuximab (CET) and cisplatin (CIS)) in locally advanced inoperable skin cancers of head and neck.
    A.3.2Name or abbreviated title of the trial where available
    HART-CIS-CET in SCCHN
    A.4.1Sponsor's protocol code numberKKSH-19
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN47339346
    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 SponsorMartin-Luther-Universität Halle-Wittenberg
    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 supportMedizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMerck Serono GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMartin-Luther-Universität Halle-Wittenberg
    B.5.2Functional name of contact pointKoordinierungszentrum für Klinische
    B.5.3 Address:
    B.5.3.1Street AddressKiefernweg 34
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.3Post code06097
    B.5.3.4CountryGermany
    B.5.4Telephone number+493455574907
    B.5.5Fax number+493455574333
    B.5.6E-mailrichter.michael@kks-halle.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 AuthorisationGermany
    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 205923-56-4
    D.3.9.2Current sponsor codeCetuximab
    D.3.9.3Other descriptive nameCET
    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 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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCisplatin
    D.3.2Product code Cisplatin
    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 INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.2Current sponsor codeCIS
    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
    Squamous cell cancer of head and neck, unresectable, locally advanced, Stage III/IVa or b (UICC, 2002)
    E.1.1.1Medical condition in easily understood language
    Cancer of head and neck, unresectable, locally advanced, Stage III/IVa or b (UICC, 2002)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    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
    Determination of feasibility, efficacy and safety of cetuximab (CET) combined with cisplatin (CIS) and hyperfractionated, accelerated radiotherapy (HART) as a treatment option with curative intent for patients with locally advanced, unresectable SCCHN.
    Phase I: defining the maximum tolerated dose (MTD) of a short infusion of cisplatin in the combined-modality treatment with cetuximab
    Phase II: Efficacy of combined-modality treatment with regards to progression-free survival. The dose of cisplatin in this combined-modality treatment will be determined in the phase I study.
    E.2.2Secondary objectives of the trial
    Phase I: Examining the dose limiting toxicities (DLT) of a short infusion of cisplatin in the combined-modality treatment with cetuximab.

    Phase II: Feasibility, efficacy and safety of combined-modality treatment with regards to overall survival, progression-free survival and tumor response.
    Evaluation of toxicity of HART-CIS-CET.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients with histologically confirmed unresectable SCC of the oral cavity (no lip), oropharynx, hypopharynx or larynx (stage III/IVa or b)
    •Unidimensionally measurable lesion
    •Signed informed consent
    •Karnofsky PS ≥ 70%
    •Age ≥ 18 and ≤ 70
    •Curative treatment intent
    •Negative serum or urine pregnancy test (women of childbearing potential)
    •Adaequate bone marrow, hepatic and renal function
    (for further details see section 5 study protocol)
    E.4Principal exclusion criteria
    •Unknown primary cancer, nasopharynx cancer or salivary gland cancer
    •Metastatic disease
    •Another cancer within 5 years of study entry
    •Serious concomitant disease or medical condition
    •Pregnancy or lactation
    •Women of child-bearing potential with unclear contraception
    •Previous treatment with chemotherapy, radiotherapy or surgery in head and neck
    •Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
    •Life expectancy < 3 months
    •Contraindications to receive cisplatin or cetuximab
    •Previous exposure to monoclonal antibodies and/or EGFR-targeted therapy
    •Social situations that limit the compliance with study requirements
    (for further details see section 5 study protocol)
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: Determination of maximum tolerated dose (MTD) of cisplatin in HART-CIS-CET measured as maximum tolerated dose of cisplatin (mg/m2)
    Phase II: Determination of 2-year progression-free survival (PFS), as measured by the 2-year progression-free survival rate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: following each administration and 8 weeks after the last administration.
    Phase II: 2 years after end of treatment
    E.5.2Secondary end point(s)
    - Progression-free survival as measured by 1- and 5-year progression-free survival rates
    - Overall survival (OS) as measured by 1-, 2- and 5-year overall survival rates
    - Loco-regional progression-free survival (LPFS) as measured by 1-, 2- and 5-year loco-regional progression-free rate
    - Objective tumor response rate (ORR) (according to RECIST)
    - Toxicity of HART-CIS-CET (according CTCAE, version 3.0)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Toxicity: following each administration and 8 weeks after the last administration; off-treatment every 6 months (year 1-2) and every 12 months (year 3-5) up to disease progression
    - PFS: 1-, 2- and 5-year after start of therapy
    - ORR: 8 weeks after end of therapy followed by every 6 months (year 1-2), every 12 months (year 3-5) up to disease progression
    - Loco-regional progression-free survival (LPFS): measured 1-, 2- and 5-year after start of therapy
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Maximum tolerated dose
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    See protocol section 12.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months8
    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) Yes
    F.1.2.1Number of subjects for this age range: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    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 state86
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 86
    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)
    See section 8.3 in study protocol
    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 Decision2005-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-10
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    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
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