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    Summary
    EudraCT Number:2013-000138-37
    Sponsor's Protocol Code Number:PERISCOPE
    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:2013-07-01
    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 number2013-000138-37
    A.3Full title of the trial
    Treatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy
    Behandeling van peritoneale uitzaaiingen in maagkanker patienten met cytoreductieve chirurgie en hypertherme intraperitoneale chemotherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy
    Behandeling van peritoneale uitzaaiingen in maagkanker patienten met cytoreductieve chirurgie en hypertherme intraperitoneale chemotherapie
    A.3.2Name or abbreviated title of the trial where available
    PERISCOPE-study
    PERISCOPE-studie
    A.4.1Sponsor's protocol code numberPERISCOPE
    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 supportNKI-AvL
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportSt. Antonius Ziekenhuis
    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 pointTrial bureau
    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 number+312051 27 496
    B.5.5Fax number+312051 22 679
    B.5.6E-mailtrial@nki.nl
    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 Eloxatin
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis
    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 IMPIntraperitoneal use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    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 for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intraabdominal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDocetaxel
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    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: 3
    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 Capecitabine CF
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm 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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    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: 4
    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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Nederland bv
    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 Powder for 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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.4EV Substance CodeSUB12612MIG
    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.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 positive peritoneal cytology.
    Maagkanker met peritoneale metastasen of positieve peritoneale cytologie
    E.1.1.1Medical condition in easily understood language
    Gastric cancer with metastasis located in the peritoneum or tumorcellen located 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 16.0
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10067093
    E.1.2Term Intraperitoneal hyperthermic chemotherapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to study the safety, tolerability and feasibility of gastrectomy combined with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) after neoadjuvant systemic chemotherapy as primary treatment option for advanced gastric cancer with tumour positive peritoneal cytology (C+) and/or limited peritoneal carcinomatosis (P+).
    Om de veiligheid, verdraagbaarheid en de haalbaarheid van gastrectomie gecombineerd met cytoreductieve chirurgie en hypertherme intraperitoneale chemotherapie (HIPEC) na neoadjuvante systemische chemotherapie als primaire behandelingsoptie voor gevorderde maagkanker met tumor positieve peritoneale cytologie (C+) en / of een beperkte peritoneale metastasen (P+) te onderzoeken.
    E.2.2Secondary objectives of the trial
    -to determine the maximum tolerated dose of intraperitoneal docetaxel in combination with a fixed dose regimen of intraperitoneal oxaliplatin in gastric cancer patients undergoing gastrectomy combined with CRS and HIPEC after neoadjuvant systemic chemotherapy with DOC or T-DOC in case of HER2-positive tumour
    -to investigate the pharmacokinetics of HIPEC after gastrectomy and CRS in patients with advanced gastric cancer and peritoneal dissemination
    -to study the effect of neoadjuvant systemic chemotherapy on peritoneal dissemination from gastric cancer (peritoneal cancer index before and after neoadjuvant chemotherapy).
    -to identify genetic profiles predictive of tumour response in patients with gastric cancer and peritoneal dissemination undergoing gastrectomy combined with CRS and HIPEC.
    -to determine the 2-year disease free and overall survival of advanced gastric cancer patients with tumour positive cytology and/or limited peritoneal carcinomatosis treated with CRS and HIPEC.
    -De maximale verdraagbare dosis van intraperitoneale docetaxel in combinatie met een vaste dosering van intraperitoneale oxaliplatine bij maagkanker patiënten die een gastrectomie gecombineerd met cytoreductieve chirurgie (CRS) en HIPEC na neoadjuvante systemische chemotherapie met DOC of T-DOC bij HER2-positieve tumor ondergaan.
    -Om de farmacokinetiek van HIPEC na gastrectomie en CRS bij patiënten met maagkanker en peritoneale verspreiding te onderzoeken.
    -Om het effect van neoadjuvante chemotherapie op peritoneale verspreiding van maagkanker (PCI vóór en na neoadjuvante chemotherapie) te bestuderen.
    -De genetische profielen voorspellend voor tumorrespons bij patiënten met maagkanker en peritoneale verspreiding die gastrectomie gecombineerd met CRS en HIPEC ondergaan te identificeren.
    -Om de 2-jaar ziektevrije en algehele overleving van maagkanker patiënten met een tumor positieve cytologie en/of een beperkte peritoneale metastasen behandeld met CRS en HIPEC te bepalen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Biopsy proven adenocarcinoma of the stomach (including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach for which the intended surgical treatment is a gastric resection and not a resection of the oesophagus and cardia)
    • T3-T4 tumour based upon CT-scan and/or EUS results
    • Tumour positive peritoneal cytology and/or peritoneal carcinomatosis limited to the upper abdominal cavity (above the transverse colon) and/or at the most at one location in the lower abdominal cavity (e.g., Douglas’ pouch, ovarian metastasis, Sister Mary Joseph nodule) confirmed by diagnostic laparoscopy
    • Age ≥ 18 years
    • WHO performance status 0-1
    • ASA classification I-III
    • Adequate bone marrow, hepatic and renal function, i.e., minimal acceptable laboratory values at start of the study inclusion:
    a. ANC ≥ 1.5 x 10^9 /L
    b. Platelet count ≥ 100 x 10^9 /L
    c. Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN
    d. Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula).
    • Wildtype for DPD*2A
    • Negative pregnancy test (urine/serum) for female patients of childbearing potential
    • Life expectancy ≥ 3 months allowing adequate follow up
    • Able and willing to undergo blood sampling for pharmacokinetics
    • Written informed consent
    • biopsie bewezen adenocarcinoom van de maag (waaronder tumoren op de oesophagogastric overgang op voorwaarde dat het merendeel van de tumor in de maag gelegen is en een maagresectie wordt uitgevoerd en niet een resectie van de slokdarm en cardia)
    • T3-T4 tumor op basis van CT-scan en / of EUS resultaten
    • Tumor positieve peritoneale cytologie en / of peritoneale metastasen beperkt tot de bovenste buikholte (boven de colon transversum) en / of hoogstens op een locatie in de onderste buikholte (bijvoorbeeld Douglas pouch, ovariale metastase, zuster Mary Joseph nodule) bevestigd door diagnostische laparoscopie
    • Leeftijd ≥ 18 jaar
    • WHO performance status 0-1
    • ASA classificatie I-III
    • Adequate beenmerg-, lever- en nierfunctie, minimaal acceptabele laboratoriumwaarden bij aanvang van inclusie:
    a. ANC ≥ 1,5 x 10^9 / L
    b. Trombocyten ≥ 100 x 10^9 / L
    c. Serum bilirubine ≤ 1,5 x ULN, en ALAT en ASAT ≤ 2,5 x ULN
    d. Creatinineklaring ≥ 50 ml / min (gemeten of berekend door de Cockcroft-Gault formule).
    • Wildtype voor DPD * 2A
    • Negatieve zwangerschapstest (urine / serum) voor vrouwelijke patiënten die zwanger kunnen worden
    • De levensverwachting ≥ 3 maanden waardoor adequate follow-up
    • In staat en bereid om bloedafname voor farmacokinetiek ondergaan
    • Schriftelijke informed consent
    E.4Principal exclusion criteria
    • Distant metastases (e.g., liver, lung, para-aortic lymph nodes) or small bowel dissemination
    • Signs of local irresectability
    • Recurrent gastric cancer
    • Metachronous peritoneal carcinomatosis
    • Prior treatment of gastric cancer with systemic anticancer therapy
    • Pregnancy, breast feeding or active pregnancy ambition
    • Unreliable contraceptive methods. Patients enrolled in this trial must agree to use a reliable contraceptive method throughout the study
    • Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type
    • A known history of hepatitis B or C with active viral replication
    • Recent myocardial infarction (< 6 months) or unstable angina.
    • Uncontrolled diabetes mellitus
    • Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment
    • Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
    • Afstandsmetastasen (bv., lever-, long-, para-aortale lymfeklieren) of verspreiding dunne darm
    • Tekenen van lokale irresectabiliteit
    • Terugkerende maagkanker
    • Metachrone peritoneale carcinomatosis
    • Voor de behandeling van maagkanker met systemische therapie tegen kanker
    • Zwangerschap, borstvoeding of actieve zwangerschap ambitie
    • Onbetrouwbare anticonceptie. Patiënten die deelnemen aan deze studie moeten akkoord gaan met een betrouwbare anticonceptiemethode gedurende de studie
    • Ongecontroleerde infectieziekte of bekende Human Immunodeficiency Virus HIV-1 of HIV-2 Type
    • Een bekende geschiedenis van hepatitis B of C met actieve virale replicatie
    • Recent myocardinfarct (<6 maanden) of onstabiele angina.
    • Ongecontroleerde diabetes mellitus
    • Elke medische conditie nog niet boven gespecificeerd, die wordt beschouwd als mogelijk, waarschijnlijk of beslist verstorend voor deelname aan de studie procedures, met inbegrip van een adequate follow-up en / of wil veilige behandeling in gevaar brengen
    • Bekende overgevoeligheid voor een van de toegepaste chemotherapeutische middelen en / of de oplosmiddelen
    E.5 End points
    E.5.1Primary end point(s)
    Treatment related toxicity (graded according to the NCI Common Toxicity Criteria version 4.0)
    Behandeling gerelateerde toxiciteit (beoordeeld door middel van de NCI Common Toxicity Criteria versie 4.0)
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 dagen
    E.5.2Secondary end point(s)
    - postoperative morbidity and mortality
    - completion of the study protocol
    - pharmacokinetic parameters (systemic, intraperitoneal fluid concentrations of oxaliplatin and docetaxel)
    - cytoreductive completeness score
    - patterns of tumour recurrence
    - disease free and overall survival
    - Postoperatieve morbiditeit en mortaliteit
    - Afronding van het studie protocol
    - Farmacokinetische parameters (systemisch en intraperitoneaal vocht van oxaliplatin en docetaxel)
    - Cytoreductieve compleetheidsscore
    - Patronen terugkeer van de ziekte
    - Ziektevrije en totale overleving
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 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 Yes
    E.6.5Efficacy Yes
    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) 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
    Dose-escalation trial
    dosis-escalatie studie
    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.8.3 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 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 years5
    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: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Normal treatment and follow-up according to national guidelines of follow-up after gastric cancer treatment.
    Normale behandeling en follow-up volgens de nationale richtlijnen van follow-up na maagkanker behandeling.
    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 Decision2013-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-25
    P. End of Trial
    P.End of Trial StatusOngoing
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