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    Summary
    EudraCT Number:2013-003046-17
    Sponsor's Protocol Code Number:BAY88-8223/16506
    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:2013-12-05
    Trial results View 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 number2013-003046-17
    A.3Full title of the trial
    A re-treatment safety study of radium-223 dichloride in subjects with
    castration-resistant prostate cancer with bone metastases who received an initial course of six doses of radium-223 dichloride 50 kBq/kg every four weeks
    Estudio de seguridad de la repetición del tratamiento de dicloruro de radio 223 en pacientes con cáncer de próstata resistente a la castración con metástasis ósea que recibieron un ciclo inicial de seis dosis de dicloruro de radio 223 de 50 kBq/kg cada cuatro semanas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating the safety of radium-223 dichloride, given as a 50kBq/kg dose every four weeks to patients with castration-resistant prostate cancer that has spread to bone, who have already been treated with a course of six doses of radium-223 dichloride 50kBq/kg every four weeks.
    Estudio para investigar la seguridad de dicloruro de radio 223, con una dosis de 50 kBq/kg cada cuatro semanas a pacientes con cáncer de próstata resistente a la castración que se ha propagado al hueso, y que ya habían sido tratados con ciclo de seis dosis de dicloruro de radio 223 de 50 kBq/kg cada cuatro semanas
    A.4.1Sponsor's protocol code numberBAY88-8223/16506
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref:"EU CTR"/ Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 No
    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 nameRadium-223 Dichloride
    D.3.2Product code BAY88-8223
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNRadium-223 dichloride
    D.3.9.1CAS number 444811-40-9
    D.3.9.2Current sponsor codeBAY 88-8223
    D.3.9.3Other descriptive nameRADIUM-223 CHLORIDE
    D.3.9.4EV Substance CodeSUB73831
    D.3.10 Strength
    D.3.10.1Concentration unit kBq/ml kilobecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Yes
    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
    Castration Resistant Prostate cancer patients with bone metastases
    Cáncer de próstata resistente a la castración con metástasis ósea
    E.1.1.1Medical condition in easily understood language
    Patients with prostate cancer which has spread to the bone
    Pacientes con cáncer de Próstata que ha pasado a los huesos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036916
    E.1.2Term Prostate cancer stage D
    E.1.2System Organ Class 100000004864
    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 safety of re-treatment with up to 6 doses of radium-223 dichloride 50 kBq/kg given every 4 weeks in subjects with castration-resistant prostate cancer (CRPC) with bone metastases who received an initial course of 6 doses of radium-223 dichloride 50 kBq/kg.
    Evaluar la seguridad de la repetición del tratamiento con un máximo de 6 dosis de dicloruro de radio 223 de 50 kBq/kg administradas cada 4 semanas en pacientes con cáncer de próstata resistente a la castración (CPRC) con metástasis ósea, que recibieron un ciclo inicial de 6 dosis de dicloruro de radio 223 de 50 kBq/kg.
    E.2.2Secondary objectives of the trial
    - Radiological progression free survival
    - Time to radiological bone progression
    - Total alkaline phosphatase (ALP) response rate
    - Time to total ALP progression
    - Percentage change in total ALP
    - Prostate specific antigen (PSA) response rate
    - Time to PSA progression
    - Overall survival
    - Pain response rate
    - Time to pain progression
    - Time to first skeletal related event (SRE)
    - SRE-free survival
    - La supervivencia libre de progresión radiológica.
    - El tiempo hasta la progresión ósea radiológica.
    - La tasa de respuesta de la fosfatasa alcalina (FA) total.
    - El tiempo hasta la progresión de la FA total.
    - El cambio del porcentaje de la FA total.
    - La tasa de respuesta del antígeno específico prostático (PSA).
    - El tiempo hasta la progresión del PSA.
    - La supervivencia global.
    - La tasa de respuesta al dolor.
    - El tiempo hasta la progresión del dolor.
    - El tiempo hasta el primer acontecimiento relacionado con los huesos (SRE).
    - La supervivencia libre de SRE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically confirmed adenocarcinoma of the prostate at any given point in time during disease history

    - CRPC (castration-resistant prostate cancer) with clinical or radiologically confirmed bone progression

    - Treatment with 6 injections of radium-223 dichloride 50 kBq/kg and no evidence of progression to bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) during the first course of treatment

    - Re-treatment with radium-223 dichloride is indicated based on one or
    more of the following:
    o Radiological progression (according to PCWG2 criteria) in bone after the initial course of radium-223 dichloride treatment or
    o Clinical progression defined as:
    - Confirmed rising PSA (2 subsequent values showing PSA increase, at least 1 week apart) after the initial course of radium-223 dichloride treatment or
    - Substantial worsening of pain after the initial course of radium-223 dichloride treatment (increase of ? 2 in the worst pain score of the Brief Pain Inventory Short Form [BPI-SF], where baseline is the value measured at the end of treatment visit of the initial course of radium-223 dichloride treatment) (Scher HI, et al. J Clin Oncol. 2008;26:1148-59)

    - Signed written informed consent prior to participating in any study related procedures. Willing and able to comply with the protocol, including follow-up visits and examinations
    - Adenocarcinoma de la próstata confirmado desde el punto de vista histológico o citológico en cualquier momento durante los antecedentes de la enfermedad.

    - CPRC ( Cáncer de próstata resistente a la castración) con confirmación clínica o radiológica de progresión ósea.

    - Tratamiento con 6 inyecciones de dicloruro de radio 223 de 50 kBq/kg y ningún indicio de progresión ósea (de acuerdo con los criterios estipulados por el Grupo de Trabajo 2 de Ensayos Clínicos sobre Cáncer de Próstata [PCWG2]) durante el primer ciclo de tratamiento.

    - Repetición del tratamiento con dicloruro de radio 223 sobre la base de uno o más de los siguientes criterios:
    -- Progresión radiológica ósea (de acuerdo con los criterios estipulados por el PCWG2) después del ciclo inicial de tratamiento con dicloruro de radio 223, o
    -- La progresión clínica,definica como:
    ---- Aumento del PSA confirmado (2 valores consecutivos que muestran un aumento del PSA obtenidos al menos con 1 semana de diferencia) después del ciclo inicial de tratamiento con dicloruro de radio 223, o bien
    ---- Empeoramiento sustancial del dolor después del ciclo inicial de tratamiento con dicloruro de radio 223 (aumento de ? 2 en la puntuación del máximo dolor según el Inventario breve del dolor ? Formulario abreviado [BPI-SF], en el cual el valor inicial se mide en la visita de finalización del tratamiento del ciclo inicial de tratamiento con dicloruro de radio 223) (Scher HI, et al. J Clin Oncol. 2008;26:1148-59).

    - Consentimiento informado por escrito firmado antes de participar en cualquier procedimiento relacionado con el estudio. Buena disposición y capacidad para cumplir con el protocolo, que incluye las visitas y los exámenes de seguimiento.
    E.4Principal exclusion criteria
    - History of a radium-223 dichloride-related serious adverse event (SAE) or CTCAE Grade 3 or 4 adverse event (AE) during or after the initial course of radium-223 dichloride treatment that led to the discontinuation of treatment

    - Less than 30 days from the last dose administered in the initial course of radium-223 dichloride treatment

    - Visceral metastases 1 cm or greater in largest diameter and / or requiring local or systemic therapeutic intervention, as assessed by abdominal and pelvic magnetic resonance imaging (MRI) / computed tomography (CT) scan and / or chest X-ray within 30 days of the start of treatment

    - Lymphadenopathy with lymph nodes exceeding 6 cm in short-axis diameter and / or requiring local or systemic therapeutic intervention. Enlarged lymph nodes of any size if the lymphadenopathy is thought to be a contributor to concurrent hydronephrosis

    - Current central nervous system (CNS) metastases

    - Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget?s disease of bone)

    - Treatment with chemotherapy after the initial course of radium-223 dichloride treatment

    - Prior hemibody external radiotherapy

    - Prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186, or rhenium-188

    - Any other serious illness or medical conditions
    -- Crohn?s disease or ulcerative colitis
    -- History of documented bone marrow dysplasia
    -- Unmanageable fecal incontinence

    - Imminent or established spinal cord compression based on clinical findings and / or MRI that has not yet been treated

    - Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
    - Antecedentes de un acontecimiento adverso grave relacionado con el dicloruro de radio 223 (AAG) o de un acontecimiento adverso (AA) de grado 3 o 4 relacionado con el dicloruro de radio 223 (según los Criterios Terminológicos Comunes para los Acontecimientos Adversos, versión 4.03) durante o después del ciclo inicial de tratamiento con dicloruro de radio 223 que provocó la interrupción del tratamiento con dicloruro de radio 223.

    - Menos de 30 días a partir de la última dosis administrada en el ciclo inicial de tratamiento con dicloruro de radio 223

    -Metástasis viscerales de 1 cm o más grandes en su diámetro mayor y/o que requieran intervención terapéutica local o sistémica de acuerdo con las evaluaciones realizadas con exploraciones mediante resonancia magnética (RM)/tomografía computerizada (TC) del abdomen y la pelvis y/o radiografía de tórax dentro de los 30 días del inicio del tratamiento.

    - Linfadenopatía con ganglios linfáticos que excedan los 6 cm de diámetro en el eje menor y/o que requieran intervención terapéutica local o sistémica. Ganglios linfáticos agrandados de cualquier tamaño si se cree que la linfadenopatía contribuye a la hidronefrosis concurrente.

    - Metástasis actuales del sistema nervioso central (SNC).

    - Afecciones crónicas asociadas al crecimiento óseo anormal no neoplásico (por ejemplo, enfermedad ósea de Paget confirmada).

    - Tratamiento con quimioterapia después del ciclo inicial de tratamiento con dicloruro de radio 223.

    - Radioterapia externa hemicorporal previa.

    - Radioterapia sistémica anterior con estroncio-89, samario-153, renio-186 o renio-188.

    - Cualquier otra enfermedad o afección médica grave:
    -- Enfermedad de Crohn o colitis ulcerosa.
    -- Antecedentes de displasia de la médula ósea documentada.
    -- Incontinencia fecal incontrolable.

    - Compresión inminente o establecida de la médula espinal basada en hallazgos clínicos y/o RM que aún no ha recibido tratamiento.

    - Otra neoplasia maligna tratada dentro de los últimos 3 años (excepto cáncer de piel no melanómico o cáncer de vejiga superficial de bajo grado de malignidad).
    E.5 End points
    E.5.1Primary end point(s)
    1) Number of participants with either treatment-related AEs (adverse events) or SAEs (serious adverse events)

    2) Number of participants with Radium-223 dichloride-related SAEs in the active follow-up period

    3) Change in complete blood count

    4) Number of participants who discontinue Radium-223 dichloride treatment due to treatment emergent AEs or death
    1) Número de participante con AA y AAG surgidos durante el tratamiento.

    2) Número de participantes con AA relacionados con el dicloruro de radio 223 durante el período de seguimiento activo.

    3) Cambios en el HC.

    4) Interrupción prematura del dicloruro de radio 223 debido a AA surgidos durante el tratamiento o la muerte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Up to 7 months - Treatment 2 (Day 1, 8, 15, 22), Day 1 of Treatment 2,3,4,5,6

    2) Up to 2 years after last treatment - q4 weeks for 12 weeks then q12 weeks until 2 years post-last dose and end of follow-up

    3) Up to 2.5 years - screen, visit 2-10 then q4 weeks for 12 weeks then q12 weeks until 2 years post-last dose and end of follow-up

    4) Up to 7 months
    1) Hasta 7 meses_ Tratamiento 2( Día 1,8,15,22) del tratamiento 2,3,4,5,6

    2) Hasta 2 años después del último tratamiento- cada 4 semanas durante 12 semanas, después cada 12 semanas hasta 2 años tras la última dose y fin de seguimiento.

    3) Hasta 2 años y medio: selección, visita 2-10, después cada 4 semanas durante 12 semanas, después cada 12 semanas hasta 2 años tras la última dosis y fin de seguimiento.

    4) Hasta 7 meses.
    E.5.2Secondary end point(s)
    1) Radiological progression free survival

    2) Time to radiological bone progression

    3) Pain response rate (defined as the number of subjects with pain response, divided by the total number of subjects evaluable for pain response)

    4) Time to pain progression (defined as the time in days from the start of treatment until occurrence of the first pain progression event)

    5) Overall survival

    6) Time to first skeletal related event (SRE)

    7) SRE-free survival
    1) Supervivencia libre de progresión radiológica

    2) Tiempo hasta la progresión ósea radiológica

    3) Tasa de respuesta de dolor( definida como el número de pacientes con respuesta de dolor, dividida por la cantidad total de pacientes para los que se puede evaluar una respuesta de dolor.)

    4) Tiempo hasta la progresión del dolor ( se define como el tiempo (en días) desde el inicio del tratamiento hasta la aparición del primer acontecimiento de progresión del dolor)

    5) Supervivencia global

    6) Tiempo hasta el primer acontecimiento relacionado con los huesos.

    7) Supervivencia libre de acontecimientos relacionados con los huesos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)Visit 8, 30 days post-last-dose,q4 weeks for 12 weeks then q12 weeks until 2 years post-last dose & end of follow-up
    2)Visit 8, 30 days post-last-dose,q4 weeks for 12 weeks then q12 weeks until 2 years post-last dose & end of follow-up
    3)Visit 2, 6, 7, 8, 9, 10 and 30 days post-last-dose
    4)Visit 2, 6, 7, 8, 9, 10 and 30 days post-last-dose
    5)Visit 1-10,30 days post-last-dose, q4 weeks for 12 weeks then q12 weeks until 2 years post-last dose and end of follow-up,q6 mo until 7 yrs post-late-dose
    6)Visit 1-10,30 days post-last-dose,q4 weeks for 12 weeks then q12 weeks until 2 years post-last dose & end of follow-up
    7)Visit 1-10,30 days post-last-dose,q4 weeks for 12 weeks then q12 weeks until 2 years post-last dose & end of follow-up
    Refer to protocol section 7.6 for further details
    1)V 8, 30 días tras-última-dosis (T-U-D), cada4 semanas durante 12 semanas, después cada12 semanas hasta 2 años T-U-D y fin periodo seguimiento
    2)V 8, 30 días T-U-D, cada4 semanas durante 12 semanas después cada12 semanas hasta 2 años T-U-D y fin periodo seguimiento
    3)V 2, 6, 7, 8, 9, 10 y 30 días T-U-D
    4) V 2, 6, 7, 8, 9, 10 y 30 días T-U-D
    5)V 1-10,30 días T-U-D, cada 4 semanas durante 12 semanas después c 12 semanas hasta 2 años T-U-D y fin periodo seguimiento, c 6 meses hasta 7 años T-U-D
    6)V 1-10,30 días T-U-D, c4 semanas durante 12 semanas después c 12 semanas hasta 2 años T-U-D y fin periodo seguimiento
    7)V 1-10,30 días T-U-D, c4 semanas durante 12 semanas después cada12 semanas hasta 2 años T-U-D & fin periodo seguimiento
    Ver sección 7.6 Protocolo para más información.
    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 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 No
    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 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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Finland
    Germany
    Ireland
    Israel
    Italy
    Norway
    Spain
    Sweden
    United Kingdom
    United States
    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 paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial 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) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 40
    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)
    Following the last dose of study drug subjects enter the active follow-up phase (clinic visits); monitored every 4 weeks for the first 12 weeks, then every 12 weeks for up to 2 years. Thereafter, subjects enter the extended active follow-up phase (telephone follow-up); follow-up every 6 months for up to 7 years after the last dose of study drug. Other therapies are allowed during the follow-up period. Subjects receiving other anticancer therapy will enter the telephone follow-up group.
    Tras la última dosis del MI, los ptes se incorporarán al período de seguimiento activo (visitas clínicas) y se les hará seguimiento cada 4 semanas durante las primeras 12 y después cada 12 semanas durante un máx de 2 años. Después pasarán al período de seguimiento activo prolongado (seguim telefónico) cada 6 meses durante un máx de 7 años. Se permiten otras terapias durante el periodo de seguimiento. Los ptes que reciban otro tto contra el cáncer entrarán en el grupo de seguimiento telefónico.
    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 Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-12
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