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    The EU Clinical Trials Register currently displays   35475   clinical trials with a EudraCT protocol, of which   5824   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-004298-41
    Sponsor's Protocol Code Number:Pancreathipec1.0.
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-004298-41
    A.3Full title of the trial
    Intrabdominal hyperthermic chemotherapy using gemcitabine to treat pancreatic carcinomatosis
    Quimioterapia intraabdominal hipertérmica mediante el uso de Gemcitabina para el tratamiento de la carcinomatosis de origen pancreático
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intrabdominal hyperthermic chemotherapy to treat pancreatic carcinomatosis
    Quimioterapia intraabdominal hipertérmica para el tratamiento de la carcinomatosis pancreática
    A.3.2Name or abbreviated title of the trial where available
    Intrabdominal hyperthermic chemotherapy to treat pancreatic carcinomatosis
    Quimioterapia intraabdominal hipertérmica para el tratamiento de la carcinomatosis pancreática
    A.4.1Sponsor's protocol code numberPancreathipec1.0.
    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 SponsorHospital General Ciudad Real
    B.1.3.4CountrySpain
    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 supportHospital General Universitario de Ciudad Real
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital General Universitario de Ciudad Real
    B.5.2Functional name of contact pointHospital General Universitario de C
    B.5.3 Address:
    B.5.3.1Street AddressCalle Obispo Rafael Torija S.N.
    B.5.3.2Town/ cityCiudad Real
    B.5.3.3Post code13005
    B.5.3.4CountrySpain
    B.5.4Telephone number34696866172
    B.5.5Fax number34926278577
    B.5.6E-mailmarcote15@yahoo.es
    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 Gemcitabine
    D.2.1.1.2Name of the Marketing Authorisation holderL01B2
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAntagonist of pyrimidines
    D.3.2Product code L01B2
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection/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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.2Current sponsor codeGemcitabine
    D.3.9.3Other descriptive nameGemcitabine
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    A population of malignant transformation stem cells, called tumor stem cells, extremely resistant to chemotherapeutic drugs, has been identified as the origin of pancreatic cancer. In our study, we developed a new therapeutic model, characterized by the application of hyperthermal intraabdominal chemotherapy with Gemcitabine, in order to eliminate locoregional tumor stem cells and improve the prognosis of neoplastic pancreatic disease
    Se ha identificado como origen del cáncer de páncreas una población de células madre con transformación maligna, llamadas células madre tumorales, extremadamente resistentes a fármacos quimioterápicos. En nuestro estudio desarrollamos un nuevo modelo terapéutico, caracterizado por la aplicación de quimioterapia intraabdominal hipertérmica con Gemcitabina, con el fin de eliminar de forma locorregional las células madre tumorales y mejorar el pronóstico de la enfermedad neoplásica pancreática.
    E.1.1.1Medical condition in easily understood language
    We apply hyperthermal intraabdominal chemotherapy to eliminate tumor stem cells, chemotherapeutic drug resistance and improve the prognosis of pancreatic cancer.
    Aplicamos quimioterapia intraabdominal hipertérmica para eliminar a las células madre tumorales, resistentes a los fármacos quimioterápicos y mejorar el prónostico del cáncer de páncreas.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    To identify the survival and morbidity and mortality associated with treatment with cytoreductive surgery and HIPEC with Gemcitabine compared to the group with conventional treatment (Cytoreductive surgery with systemic chemotherapy)
    Identificar la supervivencia y la morbimortalidad asociada al tratamiento mediante cirugía citorreductora y HIPEC con Gemcitabina respecto al Grupo con tratamiento convencional (Cirugía citorreductora junto a quimioterapia sistémica)
    E.2.2Secondary objectives of the trial
    To identify the adverse effects, complications associated with treatment with cytoreductive surgery and HIPEC with Gemcitabine compared to the Group with conventional treatment (Cytoreductive surgery with systemic chemotherapy)
    Identificar los efectos adversos, complicaciones asociada al tratamiento mediante cirugía citorreductora y HIPEC con Gemcitabina respecto al Grupo con tratamiento convencional (Cirugía citorreductora junto a quimioterapia sistémica)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Surgically resectable pancreatic adenocarcinoma
    Adenocarcinoma de páncreas resecable quirúrgicamente
    E.4Principal exclusion criteria
    · Voluntary refusal to participate in the trial
    · Existence of distant or locoregional disease that contraindicates surgical treatment, diagnosed preoperatively or in the intraoperative act
    · Existence of synchronous neoplastic disease
    · Exclusion after perioperative anesthetic study
    · Rechazo voluntario a participar en el ensayo
    · Existencia de enfermedad a distancia o locorregional que contraindica tratamiento quirúrgico, diagnosticado de forma preoperaoria o bien en el acto intraoperatorio
    · Existencia de enfermedad neoplásica sincrónica
    · Exclusión tras estudio perioperatorio anestésico
    E.5 End points
    E.5.1Primary end point(s)
    Survival
    Morbidity and mortality
    Supervivencia
    Morbimortalidad
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 meses
    E.5.2Secondary end point(s)
    Adverse effects
    Complications
    Mortality
    Efectos adversos
    Complicaciones
    Mortalidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the hospital stay
    Durante la estancia hospitalaria
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Survival
    Disease-free period
    Supervivencia
    Período libre de enfermedad
    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) 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 No
    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) 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 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
    There is a minimum follow-up period of 24 months
    Se prevé un periodo de mínimo de seguimiento de 24 meses
    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 months24
    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: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state42
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 42
    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)
    Minimum follow-up period of 24 months.
    Período de mínimo de seguimiento de 24 meses.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-23
    P. End of Trial
    P.End of Trial StatusOngoing
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