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    Summary
    EudraCT Number:2006-005499-42
    Sponsor's Protocol Code Number:AVACROSS.ML20008
    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:2007-01-23
    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 number2006-005499-42
    A.3Full title of the trial
    Tratamiento de inducción con XELOX-Bevacizumab en el adenocarcinoma localmente avanzado de recto: Estudio fase II
    A.4.1Sponsor's protocol code numberAVACROSS.ML20008
    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 SponsorACROSS (Associació Catalana de Recerca Oncològica i les seves implicacions Sanitàries i Socials)
    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 25 mg/ml concentrado para solución para perfusión
    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.3.11 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
    Adenocarcinoma localmente avanzado de recto.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10009951
    E.1.2Term Colon cancer NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinación del índice de respuestas patológicas completas.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios se detallan a continuación:

    - Porcentaje de resecciones completas (R0)
    - Evaluación de la toxicidad
    - Morbilidad quirúrgica
    - Valoración de las recidivas locales y a distancia
    - Intervalo libre de enfermedad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Todos los pacientes que se vayan a incluir en el estudio cumplirán los siguientes criterios:

    1. Edad igual o superior a 18 años.

    2. Confirmación histológica de adenocarcinoma de recto localmente avanzado y definido como tumor cuyo borde inferior está localizado a < o =12 cm del margen anal, medido por rectoscopia, con alguno de los siguientes criterios de riesgo, evaluados mediante RMN pélvica:
    - Tumor T3 de 1/3 inferior de recto
    - Tumor de 1/3 medio de recto, cuyo borde tumoral se encuentre < o = 2 mms. del
    margen de resección circunferencial (MRC) (amenaza del MRC)
    - N+ cuyo borde o margen se encuentre a < o = 2 mms. del MRC (amenaza del MRC)
    - Tumor o N+ que infiltra directamente el MRC
    - Tumor T4 (OPERABLE)
    - Cualquier T3N+

    Entendemos por N+, cualquier implante/adenopatía mesorrectal que cumpla al
    menos uno de estos 2 criterios:
    - o que su tamaño sea = ó > 6 mms. medido siempre en los planos AXIALES y
    tomando el eje corto como diámetro a medir.
    - o cualquier implante/adenopatía mesorrectal, independientemente de su tamaño,
    que presente unos contornos, márgenes o límites irregulares.

    3. Índice de Karnofsky > o = 70% y esperanza de vida superior a los 6 meses.

    4. Función renal, hepática y medular adecuada, según los siguientes criterios:
    - Neutrófilos (RAN) >o = 1.5 x 109/l.
    - Plaquetas >o =100 x 109/l.
    - Hemoglobina >o = 9 g/dl (puede ser transfundida para mantener o superar
    este nivel).
    - INR < o =1,5.
    - Bilirrubina total < o =1,5 veces el límite superior de la normalidad (LSN).
    - ALAT (SGPT) y/o ASAT (SGOT) < o =2,5 x LSN ó < o =5 x ULN en caso de metástasis
    hepáticas.
    - FA < o = 2,5 x LSN ó < o = 5 x ULN en caso de metástasis hepáticas, ó < o =10 x ULN en caso de metástasis óseas.
    - Aclaramiento de creatinina > o = 30 ml/min (calculado con al fórmula de Cockroft-Gault) o creatinina sérica < o =1,5 veces el límite superior de normalidad (LSN).

    5. Pacientes capaces de comprender los requerimientos del estudio, y desear participar en él, durante todo el estudio.

    6. Pacientes que hayan otorgado su libre consentimiento para participar en el estudio.
    E.4Principal exclusion criteria
    La presencia de alguno de los siguientes criterios de exclusión impedirá que los pacientes puedan ser incluidos en el estudio:

    1. Metástasis a distancia.

    2. Antecedentes de neoplasia infiltrante previa.

    3. Cualquier antecedente cardiológico, aunque esté compensado en la actualidad; incluye hallazgos del ECG clinicamente significativos (p. ejem. QTc*440 mseq (varones), 460 mseq (mujeres) ó bloqueo AV (2º grado, etc).

    4. Hipertensión no controlada (>150/100 mm de Hg con tratamiento crónico).

    5. Tratamiento previo con Radioterapia o con cualquiera de los fármacos en estudio.

    6. Otra enfermedad neoplásica durante los últimos cinco años (excepto carcinomas
    curados de células basales de la piel y de cervix in situ).

    7. Historia o indicios, en la exploración física de enfermedades del sistema nervioso
    central (tumor cerebral primario, convulsiones no controladas con tratamiento médico
    estándar, metástasis cerebrales o cualquier tipo o historia de ictus).

    8. Historia de incapacidad psiquiátrica que el investigador considere clínicamente
    significativa, que impida al paciente otorgar el consentimiento informado o interfiera con el cumplimiento de la ingesta de la medicación oral.

    9. Falta de integridad física del tracto gastrointestional superior, síndrome de mala
    absorción o incapacidad para tomar medicación oral.

    10. Trasplante alogénico que requieran tratamiento inmunosupresor.

    11. Fracturas óseas no cicatrizadas, heridas o úlceras severas.

    12. Antecedentes de diátesis hemorrágica o coagulopatía.

    13. Infecciones intercurrentes no controladas, severas u otras enfermedades
    concomitantes severas y no controladas.

    14. Historia de reacciones adversas severas inesperadas al tratamiento con
    fluoropirimidinas o déficit conocido de dihidropirimidina deshidrogenasa (DPD).

    15. Procedimientos de cirugía mayor, biopsias abiertas o lesiones traumáticas significativas dentro de los 28 días anteriores al comienzo del tratamiento del estudio. Aspirados con aguja fina en los 7 días anteriores al comienzo del estudio. Procedimientos de cirugía mayor que necesariamente tenga que realizarse durante el curso del estudio.

    16. Uso reciente o actual (dentro de los diez días anteriores al comienzo del tratamiento del estudio) de anticoagulantes orales o parenterales a dosis completas o agentes trombolíticos. El uso de dosis bajas de warfarina está permitido, con un INR < o =1.5.

    17. Tratamiento crónico diario con dosis altas de aspirina (>325 mg/día) o tratamiento con fármacos anti-inflamatorios no esteroideos.

    18. Haber participado en otro ensayo clínico durante las 4 semanas anteriores al comienzo del estudio.

    19. Mujeres embarazadas o en periodo de lactancia. Las mujeres en edad fértil deberan utilizar métodos anticonceptivos eficaces a lo largo del estudio y hasta 6 meses después de la última administración del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la eficacia de la combinación con BVZ, capecitabina y oxaliplatino en el tratamiento de inducción seguido de un tratamiento concomitante de RT, capecitabina y bevacizumab.
    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 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 concerned14
    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 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) 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 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 state44
    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 Decision2007-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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