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    The EU Clinical Trials Register currently displays   44020   clinical trials with a EudraCT protocol, of which   7318   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:2018-001433-41
    Sponsor's Protocol Code Number:ProPec
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-01-02
    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 - BfArM
    A.2EudraCT number2018-001433-41
    A.3Full title of the trial
    Phase II Studie zur Verminderung der Peritonealkarzinose-Inzidenz nach kurativer Gastrektomie eines Magenkarzinoms oder Adenokarzinoms des gastroösophagealen Übergangs durch hypertherme intraperitoneale Chemoperfusion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Studie zur Verminderung der Peritonealkarzinose-Inzidenz nach kurativer Gastrektomie eines Magenkarzinoms oder Adenokarzinoms des gastroösophagealen Übergangs durch hypertherme intraperitoneale Chemoperfusion
    A.4.1Sponsor's protocol code numberProPec
    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 Hospital Tuebingen
    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 supportDeutsche Krebs Hilfe
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Tuebingen
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHoppe-Seyler-Strasse 3
    B.5.3.2Town/ cityTuebingen
    B.5.3.4CountryGermany
    B.5.4Telephone number004970712986620
    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-Haemato
    D.2.1.1.2Name of the Marketing Authorisation holderHAEMATO Pharm AG
    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.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal 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.3.9.4EV 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 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.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.2.1.1.1Trade name Doxorubicinhydrochlorid
    D.2.1.1.2Name of the Marketing Authorisation holderBendalis
    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 nameDoxorubicinhydrochlorid Bendalis
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICIN HYDROCHLORIDE
    D.3.9.1CAS number 23214-92-8
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Patienten mit Magenkarzinom
    E.1.1.1Medical condition in easily understood language
    Patienten mit Magenkarzinom
    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
    Primäres Ziel der Studie ist die Schätzung des Effektes einer kombinierten Therapie mit Gastrektomie und HIPEC bei lokal fortgeschrittenem Magenkarzinom. Primäre Zielgröße ist die Inzidenz peritonealer Metastasen im CT bzw. der Anteil von Patienten, die nach einem Jahr frei von einer peritonealen Metastase bleiben. Die Studie soll Planungsdaten für eine nachfolgende Phase-III-Studie in Form eines RCT schaffen
    E.2.2Secondary objectives of the trial
    • Progressionsfreies Überleben (PFS) nach einem Jahr
    • Gesamtüberleben (OS) nach einem Jahr
    • Verträglichkeit und Sicherheit der Behandlung
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Vorliegen einer schriftlichen Einwilligungserklärung des Probanden/Patienten
    • Positive präoperativer Spülzytologie in der Staging-Laparoskopie
    • Resektable histologisch gesicherte lokal fortgeschrittene Adenokarzinome des Magens (inkl. AEG II-III): ≥cT3 und/oder cN+ und cM0 intraoperativ R0/R1 Gastrektomie (Re-Evaluationskriterium intraoperativ)
    • Neoadjuvante Chemotherapie ≥ 2 Zyklen
    Patienten in fortpflanzungsfähigem Alter und Patienten mit Partner in fortpflanzungsfähigem Alter müssen während und 3 Monate nach Ende der Studienteilnahme adäquate Verhütungsmaßnamen einhalten (Methoden der Empfängnisverhütung, die die Kriterien eines hocheffektiven Empfängnisschutzes im Sinne der „Clinical trial fertility group” recommendations (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf). Als sichere Formen der Verhütung gelten: kombinierte (Östrogen- und Progestogenhaltige) hormonelle Kontrazeption mit der Ovulationshemmung verbunden (oral, intravaginal, transdermal), nur Progesteronhaltigen hormonelle Kontrazeption mit der Ovulation Hemmung verbunden (oral, injizierbar, implantierbar), intrauterine Vorrichtung (IUD oder IUS), bilateraler Tubenverschluss, die Vasektomie des Partners1 und die dauerhafte Abstinenz.2
    1 Der vasektomierte Partner ist eine hochwirksame Verhütungsmethode, vorausgesetzt, der Partner ist der einzige Sexualpartner des WOCBP-Studienteilnehmers und der vasektomierte Partner hat eine medizinische Bewertung des chirurgischen Erfolgs erhalten
    2 Im Rahme dieser Anleitung wird sexuelle Abstinenz als äußerst wirksame Methode betrachtet, wenn sie als Verzicht auf heterosexuellen Verkehr während des gesamten Zeitraums, in dem ein mit dem Studienbehandlungen zusammenhängendes Risiko besteht, definiert ist
    E.4Principal exclusion criteria
    1. Patienten < 18 Jahren.
    2. Schwangerschaft oder Stillzeit (Gebärfähige Patientinnen müssen innerhalb von 7 Tagen vor Studieneinschluss einen negativen Schwangerschaftstest vorweisen)
    3. Fernmetastasen (ausgeschlossen durch CT des Thorax und des Abdomens. Bei klinischem Verdacht evtl. Ausschluss von ossären Metastasen durch Skelettszintigrafie oder MRT) (Fernmetastasen Re-Evaluationskriterium intraoperativ)
    4. Nicht kompensierte Herzinsuffizienz (NYHA III und IV)
    5. Schwere KHK, medikamentös nicht suffizient behandelbare kardiale Arrhythmien, unkontrollierte arterielle Hypertonie
    6. Niereninsuffizienz (Serum Kreatinin ≥ 1,5 x des Normwertes oder eine Kreatininclearance < 60 ml/min/1,73 m²
    7. Schwere pulmonale Dysfunktionen (COPD, PAH), Lungenfunktionstest bestätigt (IVC < 55 %, DLCO < 40 %)
    8. Bösartige Zweiterkrankung, die < 5 Jahre zurückliegt (Ausnahme: In-situ-Karzinom der Zervix, adäquat behandeltes Basalzellkarzinom der Haut)
    9. Teilnahme an anderen Studien, die zum Zeitpunkt des ProPeC-Studieneinschlusses noch nicht beendet sind
    10. Kontraindikationen gemäß Fachinformation Doxorubicin und Cisplatin

    E.5 End points
    E.5.1Primary end point(s)
    PrimärerEndpunkt ist der Anteil von Patienten, die nach einem Jahr frei von einer peritonealen Metastase bleiben. Die Studie soll Planungsdaten für eine nachfolgende Phase-III-Studie in Form eines RCT schaffen..
    E.5.1.1Timepoint(s) of evaluation of this end point
    PrimärerEndpunkt ist der Anteil von Patienten, die nach einem Jahr frei von einer peritonealen Metastase bleiben. Die Studie soll Planungsdaten für eine nachfolgende Phase-III-Studie in Form eines RCT schaffen..
    E.5.2Secondary end point(s)
    • Progressionsfreies Überleben (PFS) im Rahmen der onkologischen Nachsorge mittels CT alle 3 Monate innerhalb des ersten Jahres postoperativ
    • Gesamtüberleben (OS) nach einem Jahr
    • Verträglichkeit und Sicherheit der Behandlung
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Progressionsfreies Überleben (PFS) im Rahmen der onkologischen Nachsorge mittels CT alle 3 Monate innerhalb des ersten Jahres postoperativ
    • Gesamtüberleben (OS) nach einem Jahr
    • Verträglichkeit und Sicherheit der Behandlung
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned8
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state46
    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)
    none
    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 Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-06-28
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