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    Summary
    EudraCT Number:2022-004112-28
    Sponsor's Protocol Code Number:URO-EMDA-2022-1
    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:2023-01-10
    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 number2022-004112-28
    A.3Full title of the trial
    Randomized prospective study of the impact of preoperative instillation of mitomycin-C by electromotive drug administration (EMDA) in patients with non-muscle-infiltrating urothelial carcinoma
    Estudio prospectivo aleatorizado del impacto de la administración preoperatoria de mitomicina-C mediante instilación electromotiz (EMDA) en pacientes con carcinoma urotelial no musculo infiltrante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized study of the impact of pre-surgery administration of intravesical mitomycin C (bladder chemotherapy) by electromotive instillation (EMDA) in patients with "superficial" bladder cancer
    Estudio aleatorio del impacto de la administración previa a la cirugía de mitomicina C intravesical (quimioterápico en la vejiga) mediante instilación electromotiz (EMDA) en pacientes con cáncer de vejiga "superficial"
    A.4.1Sponsor's protocol code numberURO-EMDA-2022-1
    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 SponsorGuillem Abad Carratalà
    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 Castellón
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuillem Abad Carratalà
    B.5.2Functional name of contact pointGuillem Abad Carratalà
    B.5.3 Address:
    B.5.3.1Street Addressavinguda benicassim, 128
    B.5.3.2Town/ cityCastellón de la Plana
    B.5.3.3Post code12004
    B.5.3.4CountrySpain
    B.5.6E-mailgabadcar@gmail.com
    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 Medac (Mitomicina C)
    D.2.1.1.2Name of the Marketing Authorisation holderGebro Pharma S.A.
    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 Intravesical solution/solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    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 bladder tumor
    Tumor vesical no músculo invasivo
    E.1.1.1Medical condition in easily understood language
    "Superficial" bladder tumor, not invading the muscle (non-muscle invasive)
    Tumor vesical "superficial", que no invade el músculo (no músculo invasivo)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10005009
    E.1.2Term Bladder cancer stage I, without cancer in situ
    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 assess the rate of recurrence and/or progression and time free until first event in patients with non-muscle-invasive bladder tumor receiving mitomycin C with EMDA (MMC+EMDA) prior to transurethral resection of the bladder (TUR-B) compared with instillation of MMC by passive diffusion after TUR-B.
    Evaluar la tasa de recidiva y/o progresión y el tiempo libre hasta el primer evento en los pacientes con tumor vesical no músculoinvasivo que reciben mitomicina C con EMDA (MMC+EMDA) antes de la resección transuretral vesical (RTU) en comparación con la instilación de MMC por difusión pasiva tras la RTU.
    E.2.2Secondary objectives of the trial
    − To analyze the rate of progression and progression-free-survival time in patients with electromotive drug administration (EMDA) before transurethral resection of the bladder (TUR-B) compared with passive diffusion of mitomycin C (MMC) instillation after TUR.
    − Evaluate the tolerance of treatment with preoperative MMC+EMDA.
    − Quantify the percentage of patients in each group who complete with the entire treatment.
    − To assess the impact of inflammatory markers (neutrophil/lymphocyte ratio and platelet/lymphocyte ratio) on the risk of recurrence and progression of non-muscle-invasive urothelial carcinoma.
    − Analizar la tasa de progresión y el tiempo libre hasta progresión en los pacientes con EMDA antes de la RTU en comparación con la instilación de MMC por difusión pasiva tras la RTU.
    − Evaluar la tolerancia del tratamiento con MMC+EMDA preoperatoria.
    − Cuantificar el porcentaje de pacientes en cada grupos que cumplen la totalidad del tratamiento.
    − Evaluar el impacto de los marcadores inflamatorios (ratio neutrófilo/linfocito y ratio plaqueta/linfocito) en el riesgo de recurrencia y de progresión del carcinoma urotelial no musculoinfiltrante.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Patients suspected by cystoscopy and/or ultrasound of Ta or T1 urothelial cell carcinoma.
    ● Primary papillary tumor.
    ● Single or multiple low-grade recurrent tumor.
    ● Patients with preserved renal function (serum creatinine <1.12 mg/dl) and normal liver function (gamma glutamyl transpeptidase ≤51 U/L, alanine aminotransferase ≤50 U/L and total bilirubin ≤22 μmol/L).
    ● Documented and signed informed consent.
    ● Pacientes con sospecha por cistoscopia y/o ecografía de carcinoma de células uroteliales Ta o T1.
    ● Tumor papilar primario.
    ● Tumor recurrente único o múltiples de bajo grado.
    ● Pacientes con función renal conservada (creatinina sérica < 1,12 mg/dl) y función hepática normal (gamma glutamil transpeptidasa ≤51 U/L, alanina aminotransferasa ≤50 U/L y bilirrubina total ≤22 μmol/L).
    ● Consentimiento informado documentado y firmado.
    E.4Principal exclusion criteria
    ● Patients with histology other than urothelial carcinoma after pathological analysis of the surgical specimen.
    ● Patients with vesical tumor with staging ≥T2.
    ● Patients with synchronous upper urinary tract urothelial carcinoma (UTUC).
    ● Allergy to Mitomycin-C.
    ● Patient who, in the investigator's opinion, is unable to complete the study questionnaires or follow-up visits.
    ● Patients with recurrent high-grade tumor.
    ● Patients with recurrent carcinoma in situ (CIS).
    ● Decreased bladder capacity (less than 200 cc).
    ● History of high-grade bladder tumor or CIS.
    ● History of untreated urinary tract infection.
    ● Severe systemic infection.
    ● Treatment with radiotherapy or chemotherapy.
    ● Treatment with immunosuppressants.
    ● Pacemaker or implantable cardioverter defibrillator (ICD) carrier.
    ● Other malignancies during the 5 years prior to inclusion in the study (except in the case of skin cancer with effective treatment or in the case of localized cervical cancer).
    ● Pregnancy.
    ● Pacientes con histología diferente a carcinoma urotelial tras el análisis anatomopatológico de la pieza quirúrgica.
    ● Pacientes con TV con estadiaje ≥T2 .
    ● Pacientes con carcinoma urotelial de tracto urinario superior (CUTUS) sincrónico.
    ● Alergia a la Mitomicina-C.
    ● Paciente que, a criterio del investigador, sea incapaz de cumplimentar los cuestionarios del estudio o las visitas de seguimiento.
    ● Pacientes con tumor recurrente de alto grado.
    ● Pacientes con CIS recurrente.
    ● Capacidad vesical disminuida (menos de 200 cc).
    ● Antecedentes de tumor vesical de alto grado o CIS.
    ● Antecedentes de infección del tracto urinario sin tratar.
    ● Infección sistémica grave.
    ● Tratamiento con radioterapia o quimioterapia.
    ● Tratamiento con inmunosupresores.
    ● Portador de marcapasos o desfibrilador automático implantable (DAI).
    ● Otras enfermedades malignas durante los 5 años previos a la inclusión en el estudio (excepto en el caso de cáncer de piel con tratamiento efectivo o en el caso de cáncer cervical localizado).
    ● Embarazo.
    E.5 End points
    E.5.1Primary end point(s)
    Intravesical administration of EMDA-Mitomycin C pre-TURB is superior to standard intravesical administration of mitomycin C, by passive diffusion post-TURB, in terms of recurrence and progression rates.
    La administración intravesical de EMDA-Mitomicina C pre-RTU es superior a la administración intravesical estándar de mitomicina C, por difusión pasiva post-RTU, en términos de tasas de recidiva y progresión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An interim statistical analysis will be performed approximately 36 months after the start of the study with all the recruited patients. Subsequently, after completing the data collection and completing the 36-month follow-up of the sample, the definitive statistical analysis will be carried out and later the writing of the scientific work will begin.
    Se realizará un análisis estadístico intermedio aproximadamente a los 36 meses del inicio del estudio con la totalidad de los pacientes reclutados. Posteriormente, tras finalizar con la recogida de los datos y cumplimentado el seguimiento de 36 meses de la muestra, se realizará el análisis estadístico definitivo y posteriormente se iniciará la redacción del trabajo científico.
    E.5.2Secondary end point(s)
    Intravesical administration of EMDA-Mitomycin C pre-TURB is well tolerated by patients, and a very high percentage can finish the treatment.
    La administración de mitomicina C con EMDA de forma preoperatoria es bien tolerada por los pacientes, y se consigue un porcentaje de pacientes muy elevado que pueden finalizar con el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The rate of patients successfully completing treatment will be assessed. as well as the side effects that may arise during it periodically, issuing definitive results at the end of the follow-up of all patients.
    Se evaluará la tasa de pacientes que finalizan correctamente el tratamiento. así como los efectos secundarios que puedan surgir durante el mismo de forma periódica, emitiendo resultados definitivos al acabar el seguimiento de todos los pacientes.
    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) 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 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) 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 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
    o Lost to follow-up (impossible to locate the patient).
    o Patient decision: Patients can freely leave the study at any time and without any explanation.
    o Decision of the investigator.
    o Serious Adverse Event: In the event of a serious adverse event, the Investigator may recommend the patient withdraw from the study if they believe the event is secondary to study procedures.
    o Discharge from the Urology Service.
    o Others (specify).
    o Pérdida de seguimiento (imposible localizar al paciente).
    o Decisión del paciente: Los pacientes pueden salir del estudio libremente en cualquier momento y sin ninguna explicación.
    o Decisión del investigador.
    o Acontecimiento adverso grave: en el caso de que se produzca un efecto adverso grave, el investigador puede recomendar al paciente que salga del estudio si considera que el evento es secundario a procedimientos del estudio.
    o Alta del Servicio de Urología.
    o Otras (especificar).
    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 months
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state228
    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 Decision2023-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-24
    P. End of Trial
    P.End of Trial StatusOngoing
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