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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-000456-13
    Sponsor's Protocol Code Number:ML20006.XEBERECTO/ICO/005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-02
    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 number2007-000456-13
    A.3Full title of the trial
    Estudio fase II de Bevacizumab en combinación con Capecitabina y radioterapia como tratamiento preoperatorio en pacinetes con cáncer rectal localmente avanzado resecable.
    A.3.2Name or abbreviated title of the trial where available
    XEBERECTO
    A.4.1Sponsor's protocol code numberML20006.XEBERECTO/ICO/005
    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 SponsorInstitut Català d'Oncologia (ICO)
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBevacizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeFármaco antiangiogénico
    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
    Cancer rectal localmente avanzado
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10038038
    E.1.2Term Rectal cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia del tratamiento neoadyuvante con Bevacizumab, administrado bisemanalmente de forma concomitante con capecitabina y radioterapia externa, medida como tasa de respuesta patológica completa.
    E.2.2Secondary objectives of the trial
    Determinar la respuesta clínica global.
    Determinar la disminución del estadiaje.
    Determinar la supervivencia libre de progresión.
    Determinar la supervivencia global.
    Cuantificar el grado d control local: resecciones R0 en cirugía.
    Determinar el perfil de seguridad del tratamiento neoadyuvante.
    Determinar la tasa de compliaciones quirúrgicas.
    Determinar los cambios en el perfil angiogénico de los tumores.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Haber otorgado el consentimiento informado por escrito
    2. Pacientes varones o mujeres con edades comprendidas entre 18 y 75 años
    3. Con estado funcional ECOG 0 o 1
    4. Diagnóstico histológicamente confirmado de un adenocarcinoma de recto a < 15 cm del margen anal
    5. Enfermedad localmente avanzada (estadío clínico T3, T4, con presencia/ausencia de metástasis ganglionares regionales)
    6. Ausencia de metástasis a distancia)
    7. Enfermedad evaluable mediante técnicas de imagen
    8. Sin presencia de hemorragia tumoral en el término de una semana
    9. Derivación externa antes del tratamiento preoperatorio en los tumores oclusivos con clínica secundaria importante
    10. Esperanza de vida superior a 4 meses
    11. Ausencia de tratamiento previo para la enfermedad neoplásica
    12. Adecuada función de médula ósea, según los siguientes parámetros de laboratorio:
    Leucocitos ≥ 4 x 109 /l
    Neutrófilos ≥ 1.5 x 109 /l
    Plaquetas ≥ 100 x 109 /l
    Hemoglobina ≥ 10 g/dl l
    13. Adecuada función hepática, según los siguientes parámetros de laboratorio:
    o Bilirrubina <1,25 veces el límite superior de normalidad
    o AST, ALT y fosfatasa alcalina ≤2,5 veces el límite superior del rango de valores normales del centro
    14. Adecuada función renal, según los siguientes parámetros de laboratorio:
    o Creatinina sérica ≤ 106 µmol/l o bien aclaramiento de creatinina superior a 50 ml/min
    15. Estado nutricional adecuado :pérdida de peso < 10% respecto al peso habitual y nivel de albúmina < 35g/L
    E.4Principal exclusion criteria
    1. Cáncer de recto considerado irresecable:
    Afectación ósea sacra.
    Afectación ureteral bilateral.
    2. Tener antecedentes de segunda neoplasia concomitante en los últimos 5 años, con excepción de cáncer de piel no-melanoma y carcinoma de cérvix adecuadamente tratados
    3. Mujeres embarazadas o en periodo de lactancia
    4. Mujeres en edad fértil que no se comprometan a utilizar un método anticonceptivo eficaz hasta después de haber transcurrido 30 días desde la cirugía
    5. Tener antecedentes o presentar enfermedad cardiovascular clínicamente significativa (i.e., activa), como por ejemplo, hipertensión no controlada, angina inestable, insuficiencia cardiaca congestiva grado II o superior de la New York Heart Association (NYHA), arritmias cardiacas severas que requieran mediación, o enfermedad vascular periférica grado II o superior. Además, también se excluirán aquellos pacientes que hayan padecido un infarto de miocardio en el año anterior al comienzo del tratamiento del estudio
    6. Presentar falta de integridad física del tracto gastrointestinal superior, síndrome de malabsorción o incapacidad para tomar medicación oral
    7. Haberse sometido a trasplante de órganos que requiera tratamiento inmunosupresor
    8. Presentar fracturas óseas, heridas o úlceras severas no cicatrizadas.
    9. Con indicios o datos de diátesis hemorrágica o coagulopatía, INR  1.5
    10. Presentar infecciones intercurrentes no controladas, severas u otras enfermedades concomitantes severas y no controladas.
    11. Tener antecedentes de reacciones adversas severas inesperadas al tratamiento con fluoropirimidinas o déficit conocido de dihidropirimidina deshidrogenasa (DPD).
    12. Haberse sometido a una intervención de cirugía mayor, biopsias abiertas o haber tenido lesiones traumáticas significativas dentro de los 28 días anteriores al comienzo del tratamiento del estudio, o en el que esté programada una intervención de cirugía mayor que deba realizarse obligatoriamente durante el estudio. También se considera criterio de exclusión la realización de aspirados con aguja fina en los 7 días anteriores al comienzo del tratamiento del estudio
    13. Haber recibido recientemente o encontrarse en la actualidad en tratamiento (10 días antes del comienzo del tratamiento del estudio) con anticoagulantes orales o parenterales a dosis completas, o con agentes trombolíticos. El uso de dosis bajas de warfarina está permitido, con un INR ≤ 1,.5.
    14. Estar en tratamiento crónico diario con dosis elevadas de aspirina (>325 mg/día) o tratamiento con fármacos anti-inflamatorios no esteroideos (que inhiben la función plaquetaria a dosis utilizadas para el tratamiento de enfermedades inflamatorias crónicas).
    15. Haber recibido algún fármaco, agente o procedimiento en investigación, o haber participado en otro estudio de investigación durante las 4 semanas anteriores al comienzo del tratamiento con la medicación del estudio
    16. Condiciones psicológicas, familiares y geográficas que no puedan permitir un adecuado seguimiento y adherencia con el protocolo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de respuesta patológica completa: desaparición de todas las lesiones diana y ausencias de células tumorales en la pieza resecada.
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state43
    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 Decision2007-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
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