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    The EU Clinical Trials Register currently displays   41472   clinical trials with a EudraCT protocol, of which   6816   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2013-003830-34
    Sponsor's Protocol Code Number:415-13
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-09-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-003830-34
    A.3Full title of the trial
    Pleurectomy/decortication and hypterthermic intrathoracic chemotherapy compared to pleurectomy/decortication in patients with malignant pleural mesothelioma
    Pleurektomie/Dekortikation und hypertherme intrathorakale Chemotherapie (HITHOC) versus Pleurektomie/Dekortikation bei malignem Pleuramesotheliom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Thoracic Mesothelioma: Surgery with or without subsequent lavage at high temperature with addition of chemotherapy
    Pleuramesotheliom: Operation mit oder ohne anschließender Spülung bei erhöhter Temperatur mit Zusatz von Chemotherapeutika
    A.3.2Name or abbreviated title of the trial where available
    HITHOC
    HITHOC
    A.4.1Sponsor's protocol code number415-13
    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 SponsorAsklepios Fachkliniken München Gauting
    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 supportDeutsches Zentrum für Lungenforschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAsklepios Fachkliniken München-Gauting
    B.5.2Functional name of contact pointKlinik für Thoraxchirurgie
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Koch-Allee 2
    B.5.3.2Town/ cityGauting
    B.5.3.3Post code82131
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989857914207
    B.5.5Fax number+4989857914206
    B.5.6E-mailm.lindner@asklepios.com
    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 Cisplatin
    D.2.1.1.2Name of the Marketing Authorisation holderTeva
    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 Teva
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrapleural 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.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1mg/ml
    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
    malignant pleuramesothelioma
    malignes Pleuramesotheliom
    E.1.1.1Medical condition in easily understood language
    malignant pleural mesothelioma
    malignes Pleuramesotheliom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10027407
    E.1.2Term Mesothelioma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Malignant pleural mesothelioma is a yet uncurable disease, with a
    median survival of 9 months after diagnosis. Treatment is usually
    multimodulary, including operation, chemotherapy and radiation.
    HITHOC (hyperthermic intrathrocic chemotherapy) with cisplatin and
    doxorubicin is used to enhance lokal tumor control after pleurectomy
    and decortication. In some patients, survival of 2 years can be achieved.
    However, the chemotherapeutics can have severe lokal and systemic
    side effects. No data exist to which extend hyperthermia and
    chemotherapy add to the beneficial effect. The aim of this study is to compare the standard surgical procedure followed by HITHOC therapy to the standard surgery alone and thus identify the therapeutic
    option of sufficient effectivity with reduced side effects. Disease-free
    and overall survival, therapy induced morbidities and quality of life will
    be documented.
    Das Pleuramesotheliom ist eine unheilbare maligne Erkrankung, mit
    einer mittleren Überlebenszeit von 9 Monaten nach Diagnose. Die
    Behandlung erfolgt i.d.R. multimodular mit Operation, Chemotherapie
    und Radiotherapie. HITHOCH (hypertherme, intrathorakale
    Chemotherapie) mit Cisplatin und Doxorubin wird zur lokalen
    Tumorkontrolle nach Operation (Pleurektomie und Dekortikation)
    eingesetzt. In einigen Patienten können Überlebenszeiten bis zu 2
    Jahren erreicht werden. Es gibt jedoch keine Daten darüber, welchen
    Beitrag hierzu die Hyperthermie und welchen die Chemotherapie leistet. Das Ziel dieser Studie ist es, das Standard-OP-Verfahren gefolgt von HITHOC Therapie zur Standard Operation allein zu vergleichen und so eine ausreichend effektive Therapie mit den geringstmöglichen
    Nebenwirkungen zu beschreiben. Krankheitsfreies und
    Gesamtüberleben, Nebenwirkungen und Lebensqualität werden
    dokumentiert.
    E.2.2Secondary objectives of the trial
    not applicable
    trifft nicht zu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients age ≤ 80 years
    epithelioid pleural mesothelioma
    P3D is not possible or desired
    Ph. I-II; Ph. III (T1-T2 N1/N2 no LK-bulks)
    Diagnosis by biopsy VATS + Biopsy
    ECOG performance status 0-1
    Creatinine <1.2 mg / dl, GFR> 60 ml / min
    no relevant KHK
    no other primary therapy
    signed consent form
    Patientenalter ≤ 80 Jahre
    epitheloides Pleuramesotheliom
    P3D nicht möglich oder nicht gewünscht
    Stad. I-II; Stad III (T1-T2 N1/N2 keine LK-bulks)
    Diagnosestellung durch VATS + Biopsie
    ECOG Performance-Status 0-1
    Kreatinin < 1,2 mg/dl, GFR > 60 ml/min
    keine relevante KHK
    keine andere Primärtherapie
    signierte Einverständniserklärung
    E.4Principal exclusion criteria
    no signed informed consent
    inoperable
    Health does not allow the application of local chemotherapy and hyperthermia

    Cisplatin is contraindicated in patients:
    with a hypersensitivity to cisplatin, other platinum-containing drugs
    or any of the excipients
    with renal dysfunction (creatinine clearance <60ml/min)
    which are in a dehydrated state (used to prevent serious
    Impaired renal function before and after the application of a hydrogenation
    required)
    with myelosuppression
    with a hearing impairment
    with cisplatinbedingter neuropathy
    the silent
    in combination with yellow fever vaccine and prophylactic phenytoin inserted

    keine Einverständniserklärung
    nicht operabel
    Gesundheitszustand lässt die Anwendung einer lokalen Chemotherapie und Hyperthermie nicht zu

    Cisplatin ist kontraindiziert bei Patienten:
    mit einer Überempfindlichkeit gegen Cisplatin, anderen platinhaltigen Arzneimitteln
    oder einen der sonstigen Bestandteile
    mit einer renalen Dysfunktion (Kreatinin-Clearance <60ml/min)
    die sich in dehydriertem Zustand befinden (zur Vorbeugung einer schwerwiegenden
    Nierenfunktionsstörung ist vor und nach der Anwendung eine Hydrierung
    erforderlich)
    mit einer Myelosuppression
    mit einer Beeinträchtigung des Gehörs
    mit cisplatinbedingter Neuropathie
    die stillen
    in Kombination mit Gelbfieberimpfstoff und prophylaktisch eingesetztem Phenytoin


    E.5 End points
    E.5.1Primary end point(s)
    overall survival
    Gesamtüberleben
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years after inclusion of the last patient
    2 Jahre nach Einschluss des letzten Patienten
    E.5.2Secondary end point(s)
    disease free survival
    morbidiy
    quality of life
    krankheitsfreies Überleben
    Morbidität
    Lebensqualität
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 3 months
    alle 3 Monate
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Surgery only
    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 concerned2
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 80
    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 state80
    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)
    After the end of the study or after premature withdrawal patients will be treated according to the guideline for the treatment of malignant pleural mesothelioma and according to the progression of the disease. Subsequent treatment is independent of the participation in this study.
    Nach Beendigung der Studie oder nach einem frühzeitige Ausscheiden aus der Studie werden die Patienten entsprechend den Richtlinien für die Behandlung eines malignen Pleuramesothelioms und entsprechend des Fortschreitens ihrer Erkrankung weiterbehandelt. Die Weiterbehandlung ist unabhängig von der Studienteilnahme.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Deutsches Zentrum für Lungenforschung - DZL
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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