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    Summary
    EudraCT Number:2007-005755-42
    Sponsor's Protocol Code Number:GEIS 15
    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:2007-11-22
    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 number2007-005755-42
    A.3Full title of the trial
    ENSAYO CLÍNICO FASE II DE TRATAMIENTO NEOADYUVANTE CON IFOSFAMIDA A DOSIS ALTAS Y RADIOTERAPIA CONCOMITANTE EN SARCOMAS DE PARTES BLANDAS E IDENTIFICACION DE MARCADORES PREDICTORES DE RESPUESTA
    A.4.1Sponsor's protocol code numberGEIS 15
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGrupo Español de Investigación en Sarcomas
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Tronoxal
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter 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.3.1Product nameTronoxal
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Sarcomas de Partes Blandas de tronco y extremidades
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la eficacia, en términos de respuestas clínicas y patológicas, del tratamiento neoadyuvante con ifosfamida a dosis altas y radioterapia concomitante en sarcomas de partes blandas localizados de alto riesgo
    E.2.2Secondary objectives of the trial
    Determinar la tasa de pacientes que alcanzan una resección completa con márgenes libres de tumor tras el tratamiento neoadyuvante

    Determinar la tasa de pacientes en los que el tratamiento neoadyuvante permite realizar una cirugía radical de menor agresividad a la inicialmente planeada, y la de los que requerirán una cirugía más agresiva por progresión durante el tratamiento

    Determinar la supervivencia libre de recidiva y la supervivencia global de los pacientes con sarcoma localmente avanzado tratados con ifosfamida y radioterapia neoadyuvantes y posterior cirugía

    Determinar la toxicidad aguda y sobre la cicatrización de la herida quirúrgica del tratamiento neoadyuvante con ifosfamida y radioterapia

    Evaluar los cambios radiológicos y patológicos observados en respuesta al tratamiento y su correlación con la evolución clínica de los pacientes
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Estudio de factores predictivos: El estudio se realizará en las biopsias pre-tratamiento, así como en las muestras post-tratamiento disponibles.
    Las muestras serán identificadas mediante códigos que no revelen la identidad del paciente en ningún momento. Se enviarán al laboratorio de Patología Molecular de sarcomas del CIC-Salamanca de la forma descrita en los protocolos antes mencionados para que no se rompa la cadena de frío.
    La muestra pre-tratamiento se dividirá en dos partes, para la extracción de ARN y ADN. En el caso de disponer de muestras con tumor viable post-tratamiento, sólo se realizará extracción de ARN para valorar los cambios en el patrón génico con el tratamiento.

    Objetivo: Evaluar el valor predictivo de determinados marcadores moleculares sobre la respuesta al tratamiento neoadyuvante y la supervivencia
    E.3Principal inclusion criteria
    Pacientes con diagnóstico anatomopatológico de Sarcoma de partes blandas, potencialmente resecable, localizado en extremidades o tronco, correspondiente a uno de los siguientes subtipos histológicos: Leiomiosarcoma, Sarcoma pleomórfico indiferenciado (o Histiocitoma fibroso maligno), Sarcoma sinovial, Liposarcomaº y Tumor maligno de vaina nerviosa periférica.

    - El tumor primario debe cumplir las siguientes características: Tamaño ≥5cm de diámetro, aunque en caso de exéresis previa inadecuada y también en el de recidiva local tras cirugía, será elegible si se observa tumor residual medible en la RMN, aunque éste sea <5cm; grado histológico 2-3, y localización profunda

    - Ausencia de metástasis a distancia

    - No tratamiento previo con quimioterapia, ni radioterapia sobre el área del tumor, aunque sí se admiten recidivas locales tras cirugía previa

    - Edad 18 y ≤ 65 años.

    - Estado funcional (ECOG performance status) 0 - 1.

    - Enfermedad medible por criterios RECIST

    - Reserva de médula ósea adecuada, definida por recuento de neutrófilos 1.500/mm3 y plaquetas 100.000/mm3.

    - Función renal y hepática adecuadas, definidas como aclaramiento de creatinina calculado 60 ml/min, creatinina, bilirubina total, SGOT (AST) y/o SGPT (ALT) 1,5 veces el límite alto de la normalidad.

    - Consentimiento informado firmado por el paciente previamente al inicio del tratamiento.
    E.4Principal exclusion criteria
    - Embarazo o lactancia

    - Presencia de metástasis cerebrales

    - Infección activa u otras enfermedades concomitantes graves

    - Enfermedades psiquiátricas graves que impidan la obtención del consentimiento informado o que limiten el cumplimiento del tratamiento

    - Tratamiento simultáneo con otras drogas experimentales dentro de los 30 días previos a la entrada en el estudio

    - Historia de cáncer previo diagnosticado o tratado en los últimos 5 años, excepto carcinoma basocelular de piel, carcinoma in situ de cérvix o carcinoma superficial de vejiga urinaria.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluación radiológica según criterios RECIST al finalizar el tratamiento neoadyuvante mediante RMN de la lesión original (X), y evaluación patológica de la respuesta en la pieza quirúrgica (Eilber FC. J Clin Oncol 2001; Schmidt RA. Cancer 1993). Se correlacionarán con la supervivencia libre de recidiva y supervivencia global mediante los tests especificados más adelante.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    abierto, multicéntrico, no randomizado
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned10
    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 Information not present in EudraCT
    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 years3
    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 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.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Siempre que exista un representante legal, debidamente informado que haya leído la hoja de información al paciente y firme el consentimiento informado.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    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 Decision2008-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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