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    The EU Clinical Trials Register currently displays   38942   clinical trials with a EudraCT protocol, of which   6397   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2010-023035-42
    Sponsor's Protocol Code Number:FEDEGYN02/0410
    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:2012-12-17
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-023035-42
    A.3Full title of the trial
    Randomized phase III study evaluating hyperthermic intraperitoneal chemotherapy in the treatment of ovarian cancer relapse
    Ensayo clínico aleatorizado fase III para evaluar la quimioterapia hipertérmica intraperitoneal en el tratamiento de la recidiva del cáncer de ovario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase III study evaluating hyperthermic intraperitoneal chemotherapy in the treatment of ovarian cancer relapse
    Ensayo clínico aleatorizado fase III para evaluar la quimioterapia hipertérmica intraperitoneal en el tratamiento de la recidiva del cáncer de ovario
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberFEDEGYN02/0410
    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 SponsorUnicancer
    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 supportunicancer
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointBEATA JUZYNA
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75013
    B.5.4Telephone number33144235567
    B.5.5Fax number33144235569
    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. name Cisplatine
    D. of the Marketing Authorisation holderPharmacia Grupo Pfizer S.L.
    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 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 15663271
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Ovarian epithelial Cancer: intraperitoneal resectable relapse
    Cáncer epitelial de ovario: recidiva intraperitoneal resecable
    E.1.1.1Medical condition in easily understood language
    Ovarian epithelial cancer recurrent
    Cáncer de ovario epitelial recurrente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033160
    E.1.2Term Ovarian epithelial cancer recurrent
    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
    To improve overall survival at 12 months for patients in arm with HIPEC compared with patients in arm without HIPEC
    Mejorar la supervivencia a los 12 meses para los pacientes incluidos en el brazo HIPEC comparada con los pacientes del brazo sin HIPEC
    E.2.2Secondary objectives of the trial
    - Relapse-free survival.
    - Quality of life and pain: QLQ C30 and FACT O forms (functional assessment of cancer therapy for ovarian cancer) and Visual Analogue Scale (VAS).
    - Treatment related toxicities (CTC-AE v4.0) including renal toxicities.
    - Morbidity.
    - Medico-economic study: collection of socio-demographic data and patient-related management costs.
    .supervivencia libre de enfermedad
    -calidad de vida y dolor:Formularios QLQ C30 y FACT O (valoración funcional del tratamiento del cáncer para el cáncer de ovario) y escala visual analógica (VAS)
    -Toxicidades relativas al tratamiento (CTC-AE v4.0) incluyendo toxicidad renal

    -estudio médico-económico: obtención de datos socio-demográficos y costes de manejo relacionados con el paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient age ? 18 years,
    2. Performance Status WHO < 2,
    3. Previous treatment for epithelial ovarian cancer,
    4. Patient with intraperitoneal relapse (more than 6 months after the end of the initial treatment), resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal) ,
    5. Second-line platinum-based pre-operatory chemotherapy: carboplatin-paclitaxel or carboplatin-caelix,
    6. Complete cytoreductive surgery,
    7. Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 8 weeks,
    8. No hepatic insufficiency (bilirubin ? 1.5 the Upper Limit of Normal (ULN), ASAT and ALAT ? 3 ULN),
    9. No renal insufficiency (creatinine ? 1.5 ULN, creatinine clearance >60 ml/mn) calculated with MDRD method.
    10. Hematological functions : PNN ? 1.5x109/L, platelets ? 100x109/L,
    11. No contraindication to general anesthesia,
    12. Patient must be informed and the Informed Consent Form signed before any study-specific procedures start.
    13. Medical/Public Health insurance coverage
    14. Women of child-bearing age must use appropriate contraception during treatment and for 6 months after the end of treatment.
    1-Paciente de edad 18 años
    2-Performans Status OMS 2
    3-Inicialmente tratado por un cáncer de revestimiento epitelial ovárico
    4-Paciente presentando una recidiva intraperitoneal (a mas de 6 meses del fin del tratamiento inicial) resecable con residuo infraclínico sin metástasis a distancia (están autorizados: derrame pleural metastásico aislado que debe ser sensible a la quimioterapia de segunda línea a base de platino, afectación ganglionar retroperitoneal o inguinal, resecable)
    5-Quimioterapia preoperatoria de segunda línea a base de platino: sea por carboplatino-paclitaxel, sea por carboplatino-caelix
    6-Resecabilidad completa
    7-Tiempo entre el último ciclo de quimioterapia de segunda línea y la cirugía debe estar comprendido entre la 5 y la 8 semanas
    8-Ausencia de insuficiencia hepática (bilirrubina1,5 veces la tasa normal) GOT y GPT3 veces el límite superior de la tasa normal
    9-Ausencia de insuficiencia renal (creatinina  1.5 veces la tasa normal, aclaramiento de la creatinina>60 ml/mn, según método MDRD
    10-Función hematológica: PNN1,5 x 10º9/L , plaquetas 100 x 10º9/L
    11-Ausencia de contraindicación a una anestesia general para una cirugía importante
    12-Información de la paciente y firma del consentimiento informado obtenido antes del inicio de todo procedimiento específico al estudio
    13-Afiliación a la Seguridad Social
    14-Las mujeres en edad reproductiva deben tomar medidas anticonceptivas apropiadas durante el tratamiento y hasta 6 meses después del final del tratamiento
    E.4Principal exclusion criteria
    1) Patient age <18 years,
    2) Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma),
    3) Known hypersensitivity to cisplatin,
    4) Metastasis,
    5) Use of anti-angiogenic treatment,
    6) Patient with other concomitant severe life threatening disease,
    7) More than 2 segmental resections concomitant to HIPEC is foreseen,
    8) Any progressive disease during the second-line chemotherapy (platine-based),
    9) Relapse occurring less than 6 months after the end of the initial treatment,
    10) Non-epithelial ovarian tumor,
    11) Uncontrolled infection,
    12) Patient unwilling or in the incapacity to comply with the medical follow-up required by the trial because of geographic, social or psychological reasons.
    13) Clinically significant cardiorespiratory disease contraindicating the hyper hydration required for HIPEC,
    14) Patient who has already been treated by HIPEC for ovarian cancer,
    15) Persons kept in detention, or incapable of giving consent, or without a Public Health insurance coverage,
    16) Pregnant or breastfeeding woman
    1-Paciente menor de edad <18 años
    2-Antecedentes de cáncer (salvo carcinoma basocelular cutáneo o carcinoma in situ del cuello uterino), habiendo recidivado en los 5 años previos a la entrada en el estudio
    3-Hipersensibilidad conocida al cisplatino
    4-Localizaciones tumorales metastásica detectable
    5-Utilización de tratamiento antiangiogénico
    6-Afectación coexistente grave comprometiendo el pronóstico vital
    7-previsión de mas de 2 resecciones digestivas segmentarias de manera concomitante a la HIPEC
    8-Progresión de las dimensiones de la recidiva bajo quimioterapia de segunda línea
    9-Recidiva de menos de 6 meses del fin del tratamiento inicial
    10-Tumor ovárico de histología otra que del revestimiento epitelial
    11-Infección no controlada
    12-Paciente que no desea o tiene incapacidad de cumplir con los requisitos de seguimiento médico dfel ensayo por razones geográficas, sociales o psicológicas
    13-Patología cardiorrespiratoria contraindicando una hiperhidratación , que se pondrá en marcha durante la HIPEC
    14-Paciente habiendo tenido sido ya tratada con quimiohipertermia por el cáncer de ovario
    15-Persona privada de libertad o bajo tuitela, o no afiliada a un régimen de la Seguridad Social
    16-Mujer embarazada, susceptible de estarlo o durante periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    the date of death, whatever its cause, will be the main parameter used to evaluate overall survival
    La fecha del fallecimiento, por cualquier causa, será el parámetro para evaluar la supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 years
    5 años
    E.5.2Secondary end point(s)
    * Relapse-free Survival
    Relapse-free survival will be defined as the absence of clinical evidence (presence of mass, or effusion with cytologic diagnostic) and biological criteria (confirmed elevation of CA125 markers according to RUSTIN criteria) and medical imaging criteria (detection of measurable mass, with the new RECIST criteria).
    The main criteria will be the date at which relapse occurrence is detected.

    * Pain and Quality of Life :
    Quality of life (QoL) will be studied with the QLQ C30 form from EORTC and FACT O form specific for ovarian cancer (functional assessment of cancer therapy for ovarian cancer).
    Pain will be evaluated with VAS. History of chronic pain will be noted and accounted for in the analysis. Pain alleviating treatment such as epidural analgesia, the use of morphine, will be recorded in both arms (with HIPEC and without HIPEC).

    * Treatment Toxicity, renal toxicity in particular, will be evaluated with the CTC-AE v4.0 scale.

    * Morbidity :
    Morbidity evaluation will be performed until the 60th day after surgery, taking into account:
    - deaths
    - severe complications :
    -requiring patient placement in intensive care unit or an invasive medical procedure or second intervention,
    -digestive fistulas due to perforation or suture rupture,
    -deep abscess,
    -intra-abdominal hemorrhagic syndrome
    -renal toxicity requiring dialysis
    -any SAE with life-threatening implication or causing permanent invalidity/disability or severe temporary incapacity.

    * Medico-economic study: collection of socio-demographical data and patient management costs.
    § La supervivencia sin recidiva
    El criterio de juicio será la fecha de aparición de la recidiva.
    La recidiva será definida por los criterios clínicos (masa, derrame con diagnostico citológico), biológico (reelevación confirmada del CA 125), o por técnicas de imagen (aparición de una masa medible, según los nuevos criterios RECIST).
    § Toxicidad de los tratamientos según el CTC AE v4.0 (anexo 3)
    Un análisis será efectuado, especialmente sobre las consecuencias renales del CDDP en la situación de HIPEC, en las pacientes previamente sobretratadas con sales de platino.
    La necesidad eventual de diálisis será evidentemente considerada como complicación severa de grado III.
    Complicaciones quirúrgicas:
    - Complicaciones abdominales : (fístula digestiva, fístula urinaria, absceso profundo sin fístula, hemoperitoneo, número de drenajes percutáneos, pancreatitis).
    Complicaciones generales:
    - Fallos orgánicos: renal, cardiaco, pulmonar, pancreático.
    - Trombosis, embolias pulmonares.
    - Sangrados difusos o localizados.
    - Complicaciones específicas del CDDP:
    o Insuficiencia renal
    o Problemas auditivos (sordera, hipoacusia)
    o Toxicidades hematológicas (anemia, leucopenia, neutropenia, plaquetopenia)
    o Problemas digestivos
    o Toxicidades neurológicas (neuropatías periféricas, pérdida del gusto y de la sensibilidad)
    § Evaluación de la morbilidad
    Esta evaluación será hecha hasta los 60 días postoperatorios:
    - Los fallecimientos
    - Las complicaciones severas:
    o Necesidad de reingreso en la unidad de cuidados intensivos, de un procedimiento invasivo o de una reintervención,
    o Fístulas digestivas por dehiscencia de suturas o perforación,
    o Absceso profundo,
    o Síndrome hemorrágico intrabdominal,
    o Pancreatitis,
    o Toxicidad renal necesitando diálisis,
    o Todo efecto indeseable poniendo en juego el pronóstico vital o provocando una invalidez permanente o una incapacidad temporal grave.
    El estudio del dolor y la calidad de vida
    El dolor será evaluado en los dos brazos del estudio por análisis del EVA en preoperatorio y en postoperatorio, mañana, tarde y noche, durante la duración de hospitalización, y después en cada visita hasta los 6 meses. Los antecedentes dolorosos crónicos serán tenidos en cuenta en los análisis. Los tratamientos del dolor como una analgesia epidural, un tratamiento con mórficos, serán anotados y cuantificados, a la vez en el brazo HIPEC y en el brazo sin HIPEC.
    La calidad de vida será estudiada en los dos brazos del estudio a través del cuestionario QLQ C30 del EORTC y del cuestionario FACT O especifico para el cáncer de ovario (Functional Assessment of cancer Therapy for Ovarian Cancer).
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 years
    5 años
    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 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
    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. 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 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. description
    maximal surgery without HIPEC
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    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
    E.8.9.2In all countries concerned by the trial years5
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 380
    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 No
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 444
    F.4.2.2In the whole clinical trial 444
    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)
    medical controls every 6 months
    controles médicos cada 6 meses
    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 Decision2013-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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