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    Summary
    EudraCT Number:2013-005282-39
    Sponsor's Protocol Code Number:AIRC-2013-144445
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-01-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005282-39
    A.3Full title of the trial
    Effects of high Intra-abdominal pressure on tissue diffusion and pharmacokinectics of cisplatin during HIPEC
    Gli effetti dell’alta pressione intra-addominale sulla diffusione tissutale e sulla
    farmacocinetica del cisplatino durante la Chemioipertermia intraperitoneale (HIPEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of high Intra-abdominal pressure on tissue diffusion and pharmacokinectics of cisplatin during HIPEC
    Gli effetti dell’alta pressione intra-addominale sulla diffusione tissutale e sulla
    farmacocinetica del cisplatino durante la Chemioipertermia intraperitoneale (HIPEC)
    A.4.1Sponsor's protocol code numberAIRC-2013-144445
    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 SponsorFondazione IRCCS Istituto Nazionale dei Tumori di Milano
    B.1.3.4CountryItaly
    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 supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori di Milano
    B.5.2Functional name of contact pointSc Chirurgia Colon rettale
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezian 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number390223903441
    B.5.6E-mailroberta.aceto@istitutotumori.mi.it
    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 Cisplatino Sandoz*EV 50mg 100M
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameCisplatino Sandoz*EV 50mg 100M
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    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
    patients affected by peritoneal carcinomatosis from colorectal cancer or
    pseudomyxoma peritonei
    pazienti affetti da carcinosi peritoneale da ca del colon o carcinosi
    peritoneale da neoplasia mucinosa del peritoneo
    E.1.1.1Medical condition in easily understood language
    patients affected by peritoneal carcinomatosis from colorectal cancer or
    pseudomyxoma peritonei
    pazienti affetti da carcinosi peritoneale da ca del colon o carcinosi
    peritoneale da neoplasia mucinosa del peritoneo
    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 10037138
    E.1.2Term Pseudomyxoma peritonei
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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
    verify if high intra abdominal pressure during hyperthermic
    intraperitoneal chemotherapy could enhance tissue diffusion of cisplatin
    inside peritoneal residual neoplastic tissues
    valutare se l'aumento dell pressione intra-addominale udrante la
    chemioipertermia intraperitoneale (HIPEC) può
    - migliorare la penetrazione del cisplatino nei residui tumor
    E.2.2Secondary objectives of the trial
    evaluate whether high intra abdominal pressure during hipec could:
    - elicit changes on pharmacokinetics of cisplatin;
    - impact on short term surgical outcomes (morbidity, mortality, time to
    resuming bowel function, in-hospital stay)
    valutare se l'aumento della pressione intra-addominale durante la
    HIPEC può:
    - cambiare la farmacocinetica del cisplatino nel plasma ultrafiltrato e nel
    perfusato;
    - influenzare i risultati chirurgici immediati (morbi mortalità, tossicità
    sistemica, tempo per la ricanalizzaziozione intestinale e tempo di
    degenza postoperatoria).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological diagnosis of primary peritoneal carcinomatosis from
    colorectal origin orpseudomyxoma peritonei;
    2. Patients submitted to complete cytoreduction with residual tumor
    <2.5 mm;
    3. Patients at the end of cytoreduction should present the laboratorial
    and hemodynamic parameters set as followings: Mean arterial pressure > 65
    mmHg, Heart rate: < 100 bpm, Central venous pressure > 4mmHg, Cardiac index >
    2.2, SvcO2 > 72%, and haemoglobin > 8,0 gr/dl.
    Pazienti affetti da carcinosi peritoneale da carcinoma del colon-retto o
    pseudomixoma peritonei, sottoposti a intervento di citoriduzione completa con residuo di malattia <2.5mm con le seguenti caratteristiche alla fine della fase chirurgica del trattamento: Pressione arteriosa media > 65 mmHg, frequenza cardiaca: < 100 bpm, pressione venosa centrale > 4mmHg, Indici cardiaco > 2.2, SvcO2 > 72%, and hemoglobina > 8,0 gr/dl.
    E.4Principal exclusion criteria
    age>75 years, patients that does not give informed consent
    età >75 anni, assenza di consenso informato firmato
    E.5 End points
    E.5.1Primary end point(s)
    cisplatin concentration in the neoplastic residual tissue
    concentrazione tissutale di cisplatino nei tessuti residui tumorali
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 minutes after the start of HIPEC
    60 minuti dall'avvio della perfusione
    E.5.2Secondary end point(s)
    safety
    sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point
    perioperative period
    perioperatorio
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 Yes
    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
    tecnica chirurgica HIPEC secondo due livelli di pressione intra addominale
    surgical technique HIPEC considering two levels of intra abdominal pressure
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LPLV
    LPLV
    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 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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-01-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state38
    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)
    postoperative monitoring during the in hospital stay
    monitoraggio postoperatorio durante la degenza
    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 Decision2014-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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