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    The EU Clinical Trials Register currently displays   39224   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-004070-34
    Sponsor's Protocol Code Number:PRECAVE
    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:2017-11-17
    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 number2017-004070-34
    A.3Full title of the trial
    RANDOMIZED CLINICAL TRIAL, OPEN, TO EVALUATE THE BLADDER INSTILLATION OF NEOADYUVANT CHEMOTHERAPY TO THE TRANSURETHAL RESECTION OF BLADDER FOR THE PREVENTION OF RECURRENCE OF NONMUSCLE-INVASIVE UROTHELIAL CARCINOMA.
    ENSAYO CLÍNICO ALEATORIZADO, ABIERTO PARA EVALUAR LA INSTILACIÓN VESICAL DE QUIMIOTERAPIA NEOADYUVANTE A LA RESECCIÓN TRANSURETRAL DE VEJIGA PARA LA PREVENCIÓN DE RECURRENCIA DEL CARCINOMA UROTELIAL NO MÚSCULO INVASIVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CHEMOTHERAPY INSTILLATION PRIOR TO TRANSURETHAL RESECTION OF BLADDER IN THE TREATMENT OF BLADDER CANCER.
    INSTILACIÓN VESICAL DE QUIMIOTERAPIA PREVIA A LA RESECCIÓN TRANSURETRAL DE VEJIGA EN EL TRATAMIENTO DEL CÁNCER DE VEJIGA.
    A.4.1Sponsor's protocol code numberPRECAVE
    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 SponsorServicio de Urología. Hospital Universitario La Paz
    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 supportServicio de Urología Hospital Universitario La Paz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad Central de Investigación Clínica y Ensayos Clínicos del Hospital Universitario La Paz
    B.5.2Functional name of contact pointHoi Tong
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34912071466
    B.5.5Fax number34912071466
    B.5.6E-mailhoi.tong@idipaz.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 Mitomycin-C
    D.2.1.1.2Name of the Marketing Authorisation holderINIBSA HOSPITAL, S.L.U.
    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 Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMITOMYCIN
    D.3.9.1CAS number 50-07-7
    D.3.9.4EV Substance CodeSUB09006MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Non-muscle-invasive urothelial carcinoma
    Carcinoma urotelial no músculo invasivo
    E.1.1.1Medical condition in easily understood language
    Urothelial carcinoma
    Carcinoma urotelial
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Evaluation of the NMIUC early recurrence rate comparing intravesical instillation of neoadjuvant chemotherapy with RTUV with conventional TURR without neoadjuvant chemotherapy.
    Evaluación de la tasa de recurrencias tempranas del CVNMI comparando la instilación intravesical de quimioterapia neoadyuvante a RTUV con la RTUV convencional sin quimioterapia neoadyuvante.
    E.2.2Secondary objectives of the trial
    1. Assessment of toxicity, adverse events and complications attributable to intravesical instillation of pre-RTUV chemotherapy.
    2. To determine the rate of late recurrences (between 12 and 60 months after the intervention) in both groups.
    3. Compare the free time of recurrences between both groups.
    4. Determine clinical and demographic variables that could influence a better clinical response.
    1. Evaluación de la toxicidad, eventos adversos y complicaciones atribuibles a la instilación intravesical de quimioterapia previa a la RTUV.
    2. Determinar tasa de recurrencias tardías (entre 12 y 60 meses tras la intervención) en ambos grupos.
    3. Comparar el tiempo libre de recurrencias entre ambos grupos.
    4. Determinar variables clínicas y demográficas que pudieran influir en una mejor respuesta clínica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of both genders with ages between 18 and 70 years.
    2. Patients with clinical and/or radiological images of bladder tumor with indication of RTUV.
    3. Patients with a history of NMIUC in stage: Ta/T1, G1-G3, without concomitant CIS (Carcinoma in situ), with a disease-free period of at least 6 months.
    4. Score on the Karnofsky scale > 70%.
    5. Patients who agree to participate in the study by signing informed consent.
    1. Pacientes de ambos sexos con edades comprendidas entre 18 y 70 años.
    2. Pacientes con evidencia clínica y/o de imágenes de tumor vesical con indicación de RTUV.
    3. Pacientes con antecedente de CVNMI en estadio: Ta/T1, G1-G3, sin CIS (Carcinoma in situ) concomitante, siempre que tengan un período libre de enfermedad de al menos 6 meses.
    4. Puntaje en la escala de Karnofsky > 70%.
    5. Pacientes que estén de acuerdo en participar en el estudio mediante la firma del consentimiento informado.
    E.4Principal exclusion criteria
    1. Solid-looking or invasive muscle tumors on cystoscopy and/or preoperative imaging tests.
    2. Patients in whom it is expected that follow-up will not be possible for any reason.
    3. Patients that for any reason should not be included in the study according to individual evaluation of the research team.
    1. Tumores de aspecto sólido o músculo invasivo en la cistoscopia y/o pruebas de imagen preoperatorias.
    2. Pacientes en los que se prevea que no va a ser posible el seguimiento por cualquier motivo.
    3. Pacientes que por cualquier motivo no deberían ser incluidos en el estudio según evaluación individual del equipo investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of early recurrence of NMIUC.
    Tasa de recurrencia temprana de CVNMI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    1. Adverse events.
    2. Demographic characteristics (age, sex).
    3. Clinical characteristics (TNM classification, risk group, time of evolution, previous treatments received).
    1. Eventos adversos.
    2. Características demográficas (edad, sexo).
    3. Características clínicas (clasificación TNM, grupo de riesgo, tiempo de evolución, tratamientos previos recibidos).
    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 Yes
    E.6.3Therapy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.3.1Comparator description
    Resección transuretral de vejiga
    Transurethral resection of the bladder
    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
    LVLS
    Última visita del último sujeto
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 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 state240
    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)
    None
    Ninguno
    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 Decision2018-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
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