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    Summary
    EudraCT Number:2011-001715-31
    Sponsor's Protocol Code Number:EC-CG/AD-01/11
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-09-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-001715-31
    A.3Full title of the trial
    Cytoreduction with or without intraoperative intraperitoneal hyperthermic chemotherapy (HIPEC) in patients with peritoneal carcinomatosis from ovarian cancer , fallopian tube or primary peritoneal carcinoma : randomized clinical trial.
    Cotirreducción y quimioterapia intraperitoneal intraoperatoria hipertermica (HIPEC) versus citorreducción aislada en carcinomatosis peritoneal por carcinoma de ovario, trompa de falopio o carcinoma peritoneal primario.Ensayo clínico aleatorizado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cytoreduction with or without intraoperative intraperitoneal hyperthermic chemotherapy (HIPEC) in patients with peritoneal carcinomatosis from ovarian cancer , fallopian tube or primary peritoneal carcinoma : randomized clinical trial.
    Cotirreducción y quimioterapia intraperitoneal intraoperatoria hipertermica (HIPEC) versus citorreducción aislada en carcinomatosis peritoneal por carcinoma de ovario, trompa de falopio o carcinoma peritoneal primario.Ensayo clínico aleatorizado.
    A.3.2Name or abbreviated title of the trial where available
    CarcinoHIPEC
    CarcinoHIPEC
    A.4.1Sponsor's protocol code numberEC-CG/AD-01/11
    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 SponsorFundación para la Formación e Investigación Sanitaria de la Región de Murcia
    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 supportFundación para la Formación e Investigación Sanitaria
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Formación e Investigación Sanitaria de la Región de Murcia
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressHospital U. Virgen de la Arrixaca,Edificio AECC ,1ªPlanta,Crtra. Madrid-Cartagena,sn
    B.5.3.2Town/ cityEl Palmar
    B.5.3.3Post code30120
    B.5.3.4CountrySpain
    B.5.4Telephone number34968381290
    B.5.5Fax number34968381289
    B.5.6E-mailisabel.vasallo@carm.es
    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 1mg/ml , concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFerrer Farma
    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.3.4Pharmaceutical 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.3.8 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.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
    Peritoneal carcinomatosis from ovarian cancer, fallopian tube or primary peritoneal carcinoma.
    Carcinomatosis peritoneal por carcinoma de ovario , trompa de falopio o carcinoma peritoneal primario.
    E.1.1.1Medical condition in easily understood language
    Peritoneal carcinomatosis from ovarian cancer, fallopian tube or primary peritoneal carcinoma.
    Carcinomatosis peritoneal por carcinoma de ovario , trompa de falopio o carcinoma peritoneal primario.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    Investigate whether the administration of HIPEC with Cisplatin (75 miligrams per square meter of body surface) after surgical cytoreduction in women with ovarian , tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.
    Investigar si la administración de HIPEC con Cisplatino (75 miligramos por metro cuadrado de superficie corporal) tras la citorreducción quirúrgica de máximo esfuerzo en mujeres con cácer de ovario, tubárico o carcinoma peritoneal primario aumenta el intervalo libre de enfermedad con respecto a la citorreducción aislada sin HIPEC.
    E.2.2Secondary objectives of the trial
    - Evaluation of overall survival.
    - Study of morbidity.
    - Evaluation of quality of life related to the procedure.
    - Study of Ex vivo correlation.
    - Evaluación de la supervivencia global.
    - Estudio de la morbimortalidad.
    - Evaluación de la calidad de vida relacionada con el procedimiento.
    - Estudio de la correlacion Ex vivo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma.
    - Residual tumor < 2.5 mm after completion of cytoreductive surgery.
    - Aged < 75 years.
    - Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group).
    - Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm3.
    - Adequate renal function with creatinine ? 1.5 mg/ dl.
    - Adequate liver function with bilitubin levels ? 1.5 mg / dl and AST and ALT ? 80 IU / L.
    - Optimal cardiopulmonary function.
    - In recurrences, disease-free interval > 6 months.
    - Voluntary and signed written infromed consent.
    - Carcinomatosis peritoneal debidas a carcinoma epitelial de ovario (estadio III o superior), carcinoma de la trompa de Falopio y Carcinoma peritoneal primario.
    - Tumor residual < 2.5 mm después de la finalización de la cirugía citorreductora.
    - Edad < 75 años.
    - Situación basal ECOG 0-1 (Eastern Cooperative Oncologic Group)
    - Adecuada función de la médula ósea con hemoglobina ? 8 g/dl ( después de la correción en caso de anemia por deficiencia de hierro) recuento leucocitario con ? 3,000 /mm3 , plaquetas ? 100,000/mm3.
    - Adecuada funcion renal con cifras de creatinina ? 1,5 mg/dl.
    - Adecuada función hepática con cifras de bilirrubina ? 1,5 mg/dl y AST y ALT ? 80 UI/L.
    - Optima función cardiopulmonar.
    - En recurrencias, intervalo libre de enfermedad > 6 meses.
    - Participación voluntario y firma de consetimiento informado por escrito.
    E.4Principal exclusion criteria
    - Extraperitoneal tumor disease.
    - Suboptimal debulking (residual tumor > 2.5 mm).
    - Previous history of other malignancies (excluding skin)
    - Intestinal obstruction at the time of evaluation.
    - Renal failure.
    - Heart failure.
    - Uncontrolled infection.
    - Pregnant or lactating patients.
    - In recurrences, disease-free interval < 6 months.
    - Hypersensitivity to cispñatin previously.
    - Have been subjected to a procedure previously HIPEC.
    - Denial of diseased part of the study.
    - Enfermedad tumoral extraperiotoneal ( cerebro,hueso, parenquima pulmonar y los ganglios linfáticos supraclaviculares).
    - Citorreducción subóptima (tumor residual > 2.5 mm).
    - Historia previa de otras neoplasias malignas ( excepto cutáneas).
    - Obstrucción intestinal en el momento de la evaluación.
    - Insuficiencia renal.
    - Insuficiencia cardiaca.
    - Embarazadas o pacientes en periodo de lactancia.
    - En recurrencias, intervalo libre de enfermedad < 6 meses.
    - Hipersensibilidad conocida previamente a cisplatino.
    - Haber sido sometida a un procedimiento HIPEC previamente.
    - Negación de la enferma a formar parte del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Variable: difference in disease-free survival of at least 20 % for the experimental group (HIPEC) versus conventional treatment group (surgery alone).
    Safety Variable: Profile of adverse events in both groups.
    Variable de Eficacia: diferencia en la supervivencia libre de enfermedad de al menos el 20 % a favor del grupo experimental ( HIPEC) frente al grupo de tratamiento convencional (solamente cirugia).
    Variable de Seguridad: reegistro de acontecimientos adversos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every three mounths during two years and half and every six mounths during two years and half.
    Cada tres meses durante dos años y medio y cada 6 meses durante dos años y medio.
    E.5.2Secondary end point(s)
    Overrall survival
    Morbimortality
    Quality of life to the procedure
    Ex vivo correlation
    Supervivencia global
    Morbimortalidad
    Calidad de vida relacionada con el procedimiento
    Correlación Ex vivo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every three mounths during two years and half and every six mounths during two years and half.
    Cada tres meses durante dos años y medio y cada 6 meses durante dos años y medio.
    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 No
    E.8.1.3Single blind Yes
    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
    solo cirugía
    just surgery
    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 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
    The end of the trial coincides with the last visit of the last patient enrrolled in the trial.
    El final del ensayo coincidirá con la última visita del último paciente incluido en el ensayo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state126
    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)
    Treatment is not different from expected normal treatment of that condition
    El tratamiento no es diferente al tratamiento normal de la patologia
    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 Decision2011-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-11-30
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