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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2015-005695-15
    Sponsor's Protocol Code Number:NL56123.031.15
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-11-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-005695-15
    A.3Full title of the trial
    Treatment of PERitoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the PERISCOPE II study
    Behandeling van het peritoneaal gemetastaseerde maagcarcinoom met cytoreductie en hypertherme intraperitoneale chemotherapie (HIPEC): de PERISCOPE II studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study designed to compare the effect of two treatment types in gastric cancer patients with peritoneal metastasis, standard systemic chemotherapy vs surgery combined with hyperthermic chemotherapy in the abdominal cavity.
    Een wetenschappelijk onderzoek bij maagkankerpatiënten met uitzaaiingen op het buikvlies naar het effect van een operatie in combinatie met verwarmde chemotherapie in de buikholte (HIPEC) vergeleken met de standaard behandeling bestaande uit systemische chemotherapie.
    A.3.2Name or abbreviated title of the trial where available
    PERISCOPE II-study
    PERISCOPE II-studie
    A.4.1Sponsor's protocol code numberNL56123.031.15
    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 SponsorNKI-AVL
    B.1.3.4CountryNetherlands
    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 supportNederlands Kanker Instituut - Antoni van Leeuwenhoek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNKI-AVL
    B.5.2Functional name of contact pointJohanna van Sandick
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205121111
    B.5.5Fax number00310205121111
    B.5.6E-mailj.v.sandick@nki.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Eloxatin
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraabdominal use (Noncurrent)
    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 Docetaxel Sandoz
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraabdominal use (Noncurrent)
    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
    Gastric cancer with peritoneal carcinomatosis or tumour positive cytology
    Maagkanker met peritoneale metastasen of tumorpositieve peritoneale cytologie
    E.1.1.1Medical condition in easily understood language
    Gastric cancer with peritoneal metastasis or tumour cells in the abdominal fluid
    Maagkanker met buikvliesmetastasen of kankercellen in het buikvocht
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10017812
    E.1.2Term Gastric neoplasms malignant
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061269
    E.1.2Term Malignant peritoneal neoplasm
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10057647
    E.1.2Term Cytoreductive surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10067093
    E.1.2Term Intraperitoneal hyperthermic chemotherapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061965
    E.1.2Term Gastrectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052171
    E.1.2Term Peritoneal carcinoma
    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
    The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. systemic palliative chemotherapy.
    Doel van de studie is om te bepalen of een operatie bestaande uit een maagresectie, cytoreductie en HIPEC bij maagkanker patiënten met beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie de overleving verbetert in vergelijking met de huidige standaard behandeling (palliatieve systemische chemotherapie).
    E.2.2Secondary objectives of the trial
    - To compare the progression free survival between gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC and those treated with the current standard treatment, i.e. palliative systemic chemotherapy.
    - To study treatment-related toxicity in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated with gastrectomy, cytoreductive surgery and HIPEC.
    - To compare the costs and health benefits of a gastrectomy in combination with cytoreductive surgery and HIPEC, to the costs and health benefits of standard palliative systemic chemotherapy in patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology.
    - To identify genetic profiles related to tumour response in gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology. (Optional)
    - Het vergelijken van progressie-vrije overleving tussen maagkanker patiënten met beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie behandeld met een maagresectie, cytoreductieve chirurgie en HIPEC en degenen behandeld met de huidige standaard behandeling, namelijk, palliatieve systemische chemotherapie.
    - Het bestuderen van de toxiciteit na een behandeling met maagresectie, cytoreductieve chirurgie en HIPEC.
    - Het vergelijken van behandelkosten en gezondheidswinst tussen maagkanker patiënten met beperkte peritonitis carcinomatosa en/of tumor positieve peritoneale cytologie behandeld met een maagresectie, cytoreductieve chirurgie en HIPEC en degenen behandeld met de huidige standaard behandeling, namelijk, palliatieve systemische chemotherapie.
    - Het identificeren van genetische profielen die gerelateerd zijn aan tumorrespons
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - cT3-cT4 adenocarcinoma (or undifferentiated carcinoma) of the stomach, considered to be resectable
    - Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology (proven by laparoscopy or laparotomy)
    - Absence of disease progression during prior systemic chemotherapy
    - WHO performance status 0-2
    - Adequate bone marrow, hepatic and renal function
    - Leeftijd > 18 jaar
    - Potentieel resectabel cT3-cT4 adenocarcinoom (of ongedifferentieerd carcinoom) van de maag
    - Beperkte peritonitis carcinomatosa (PCI <7) en/of tumor positieve peritoneale cytologie (vastgelegd d.m.v. een laparoscopie of laparotomie)
    - Geen ziekteprogressie tijdens systemische chemotherapie (gegeven voorafgaand aan inclusie)
    - WHO performance status 0-2
    - Adequate beenmerg-, lever- en nierfunctie
    E.4Principal exclusion criteria
    - Distant metastases or small bowel dissemination
    - Recurrent gastric cancer
    - Prior resection of the primary gastric tumour
    - Non-synchronous peritoneal carcinomatosis
    - Current other malignancy (other than cervix carcinoma and basalioma)
    - Hepatitis B or C, known HIV infection or an uncontrolled infectious disease
    - Recent myocardial infarction (< 6 months) or unstable angina
    - Uncontrolled diabetes mellitus
    - Pregnancy or breast feeding
    - Any medical condition that is considered to interfere with study procedures and/or would jeopardize safe treatment
    - Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
    - Afstandsmetastasen of peritoneale metastasering op de dunne darm
    - Recidief maagcarcinoom
    - Eerdere resectie van het primaire maagcarcinoom
    - Niet-synchrone peritonitis carcinomatosa
    - Aanwezigheid van een andere maligniteit (behalve cervixcarcinoom of basaalcelcarcinoom)
    - Hepatitis B of C, HIV-infectie of een ongecontroleerde infectie ziekte
    - Recent myocard infarct (< 6 maanden) of instabiele angina pectoris
    - Ongecontroleerde diabetes mellitus
    - Zwangerschap en/of het geven van borstvoeding
    - Iedere medische aandoening waarvan te verwachten is dat deze interfereert met de studieprocedures of een veilig behandeltraject
    - Bekende overgevoeligheid voor één van de gebruikte chemotherapeutica en/of oplosmiddelen
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    Overleving
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival will be calculated when 80 deaths are observed.
    De overleving wordt berekend na het overlijden van 80 patiënten.
    E.5.2Secondary end point(s)
    - Progression free survival
    - Treatment-related toxicity
    - Costs and resource use
    - Quality of life, utilities
    - Genetic profiles related to tumour response (optional)
    - Progressie-vrije overleving
    - Aan de behandeling gerelateerde toxiciteit
    - Kosten van de behandeling en de benodigdheden
    - Kwaliteit van leven
    - Genetische profielen gerelateerd aan de tumorrespons (optie)
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 years
    4 jaar
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state106
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 226
    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)
    Patient treatment after the end of the study will be the same as for patients that did not participate.
    Patiënten zullen na het einde van de studie op dezelfde manier worden behandeld als patiënten die niet deelnamen aan de studie.
    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 Decision2016-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-14
    P. End of Trial
    P.End of Trial StatusOngoing
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