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    Summary
    EudraCT Number:2013-005087-25
    Sponsor's Protocol Code Number:NeoPAN01-2013
    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:2014-04-01
    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 number2013-005087-25
    A.3Full title of the trial
    Gemcitabine plus nab-paclitaxel versus folfirinox as neoadjuvant treatment in patients with potentially resectable pancreatic carcinoma. NeoPAN Study
    Tratamiento Neoadyuvante con gemcitabina mas nabpaclitaxel versus folfirinox en pacientes con carcinoma de páncreas potencialmente resecable. Estudio NeoPAN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gemcitabine plus nab-paclitaxel versus folfirinox in patients with potentially resectable pancreatic carcinoma.
    Tratamiento con gemcitabina mas nabpaclitaxel frente a folfirinox en pacientes con cáncer de páncreas potencialmente operable.
    A.3.2Name or abbreviated title of the trial where available
    NeoPAN
    NeoPAN
    A.4.1Sponsor's protocol code numberNeoPAN01-2013
    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 SponsorFUNDACION HOSPITAL DE MADRID
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Hospital de Madrid
    B.5.2Functional name of contact pointDr. Rafael álvarez
    B.5.3 Address:
    B.5.3.1Street AddressOña, 10
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28050
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917567984
    B.5.6E-mailralvarezgallego@hmhospitales.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 Gemcitabine
    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 Powder for solution for infusion
    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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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 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.IMP: 2
    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 Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe 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 Powder for solution for infusion
    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 INNPACLITAXEL ALBUMIN-BOUND
    D.3.9.1CAS number 33069-62-4
    D.3.9.3Other descriptive namePACLITAXEL ALBUMIN-BOUND
    D.3.9.4EV Substance CodeSUB127678
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    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 Oxaliplatin
    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 Concentrate for solution for infusion
    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 INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 4
    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 IRINOTECAN HYDROCHLORIDE
    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 Concentrate for solution for infusion
    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 INNIRINOTECAN HYDROCHLORIDE
    D.3.9.1CAS number 136572-09-3
    D.3.9.3Other descriptive nameIRINOTECAN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02772MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 5
    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 Fluorouracil
    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 nameFluorouracil
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluorouracil
    D.3.9.1CAS number 51-21-8
    D.3.9.3Other descriptive name5-FLOUROURACIL
    D.3.9.4EV Substance CodeSUB27520
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 6
    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 Leucovorin
    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 Powder and solution for 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 INNFolinic acid
    D.3.9.1CAS number 1492-18-8
    D.3.9.3Other descriptive nameLEUCOVORIN
    D.3.9.4EV Substance CodeSUB50064
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Potentially resectable pancreatic cancer
    Carcinoma de páncreas potencialmente resecable
    E.1.1.1Medical condition in easily understood language
    Pancreatic cancer which can be surgically resected.
    Cancer de páncreas que puede ser operado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10033608
    E.1.2Term Pancreatic cancer resectable
    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 evaluate the variation of the elastographic index between patients treated with Gemcitabine plus nab-paclitaxel and patients treated with FOLFIRINOX
    Comprobar la variación en el índice de elastografía entre los pacientes tratados con gemcitabina mas nabpaclitaxel y los tratados con FOLFIRINOX
    E.2.2Secondary objectives of the trial
    - To compare Cancer Associated Fibroblasts (CAF) density in the tumor samples between both arms
    - To assess tumor response by RECIST criteria in both arms
    - To determine the surgery rates in both arms and rates of R0 resections (R0 is defined as complete resection with no tumor within 1 mm of resection margins) in both arms.
    - Histological response (according to Ryan criteria) in both arms.
    - Progression-free survival in both arms.
    - Overall survival in both treatment groups
    - To measure tumor vascularization changes by MisoPet before and after treatment with FOLFIRINOX and with Gemcitabine plus nab-paclitaxel, and their correlation with vascularization of the surgical sample in both arms.
    - Determine CA19.9 decrease in patients treated with FOLFIRINOX and patients treated with Gemcitabine plus nab-paclitaxel at the end of the neoadyuvant treatment.
    - Assessment of CA19.9 early decrease in both arms
    - Comparar la densidad de CAF (fibroblastos activados) entre ambos brazos
    - Valoración de respuesta tumoral mediante criterios RECIST en uno y otro brazo.
    - Tasa de cirugías en ambos brazos y tasa de cirugía R0 (borde de resección a más de 1mm) en ambos brazos.
    - Valoración de respuesta histológica (según adaptación de criterios de Ryan) en uno y otro brazo.
    - Supervivencia libre de progresión en uno y otro brazo
    - Supervivencia Global en cada uno de los brazos
    - Medición de cambios de la vascularización tumoral por MisoPET antes y después del tratamiento en ambos brazos y su correlación con la vascularización en la pieza quirúrgica en ambos brazos.
    - Valoración del descenso de CA19.9 en pacientes tratados con FOLFIRINOX y con GemNabPTX al finalizar el tratamiento neoadyuvante.
    - Valoración del descenso precoz de CA19.9 en pacientes tratados con FOLFIRINOX y con nabpaclitaxel (descenso precoz se considera descenso mayor de 20% en el primer mes de tratamiento)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Patients with cytological or anathomopathological diagnosis of pancreatic carcinoma
    2- The pancreatic tumor is resectable or borderline
    3- Older than 18 years
    4- ECOG performance status 0-1
    5- Adequate hematologic function:
    a. Neutrophils > 1.500
    b. Hemoglobin > 9
    c. Platelets > 100.000
    6- Adequate liver and kidney function:
    a. Bilirubin <= 1,5 ULN
    b. AST <= 3 ULN
    c. ALT ? 3 ULN
    d. Creatinine clearance >= 40ml/min
    7- Signed informed consent
    1.- Pacientes con diagnóstico o citológico anatomopatológico de carcinoma de páncreas
    2.- El tumor de páncreas es resecable o borderline.
    3.- Edad mayor de 18 años
    4.- Buen estado funcional medido como ECOG 0-1
    5.- Adecuado perfil de hemograma:
    - Neutrófilos >1500
    - Hemoglobina > 9
    - Plaquetas >100.000
    6.- Adecuado perfil bioquímico
    - Bilirubina <= 1,5 ULN
    - AST <= 3 ULN
    - ALT <= 3 ULN
    - Aclaramiento de Creatinina >=40ml/min
    7.- Firma de Consentimiento Informado
    E.4Principal exclusion criteria
    1.- Patients unable to complete the study procedures for geographical, psychiatric or social reasons.
    2.- Patients with some physical or psychical condition which contraindicates the study treatment
    3.- Patients with active infection or another significant or autoimmune disease.
    4.- ECOG performance status >= 2.
    5.- Chronic hepatic disease (cirrhosis, chronic hepatitis)
    6.- Another solid or hematologic concurrent tumor or previous tumors for the last 5 years. (except for basal cell carcinoma and skin epidermoid no relapsed tumors)
    7.- Pregnancy or breastfeeding period. Women of child-bearing potential and men have to use contraceptive methods or be surgically sterilized.
    8.- Patients who are taking oral anticoagulants and it cannot be replaced for subcutaneous low molecular weight heparin.
    9.- Distant pancreatic cancer metastasis.
    10.- Patients who have been previously treated for pancreatic carcinoma with radiotherapy, chemotherapy or surgical treatment different from biliary derivation or biopsy.
    11.- Impossibility or contraindication to complete any study procedure (Eco-endoscopy, NMR, MisoPET)
    12.- Prior history of neuropathy or polyneuropathy
    1. Pacientes que no puedan completar los procedimientos del estudio por motivos geográficos, psiquiátricos o razones sociales.
    2. Pacientes con cualquier condición física o psíquica que, a criterio del investigador, contraindique el tratamiento dentro de estudio.
    3. Infección activa u otra enfermedad grave o trastorno autoinmune.
    4. Estado funcional no óptimo medido como ECOG mayor o igual a 2
    5. Enfermedad crónica hepática conocida (cirrosis, hepatitis crónica).
    6. Otros tumores sólidos o hematológicos concurrentes o historia de tumores previos en los últimos 5 años (a excepción de tumores basocelulares o epidermoides de piel no recaídos).
    7. Embarazo o lactancia. Las mujeres que estén en edad fértil deben aceptar usar un método anticonceptivo si no son quirúrgicamente estériles.
    8. Pacientes que estén recibiendo anticoagulación oral y no se pueda modificar por heparina de bajo peso subcutánea.
    9. Metástasis a distancia de adenocarcinoma de páncreas
    10. Haber recibido tratamiento previo para carcinoma de páncreas ya sea radioterapia, quimioterapia o tratamiento quirúrgico diferente a derivación biliar o intervención para obtener muestra.
    11.- Imposibilidad o contraindicación para realizar cualquier procedimiento del estudio (ECOendoscopia, RMN, MisoPET)
    12.- Antecedente de neuropatía o polineuropatía previa
    E.5 End points
    E.5.1Primary end point(s)
    The means of the difference in elastographic values before and after treatment in both arms will be compared
    Se comparará la media de diferencia del valor de elastografía antes y después del tratamiento en cada uno de los brazos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before and after both arms treatment
    Antes y después del tratamiento
    E.5.2Secondary end point(s)
    - PET-TAC.- 18FDG-PET will be used for measure SUV max (Standard Uptake Value max) for pancreatic lesion. EORTC criteria will be following in order to assess PET response.
    - CA19.9 response
    - Thorax-abdomen-pelvis TAC with iv contrast. RECIST 1.1 criteria will be followed. For response evaluation: ((Post-basal value ? basal value)/basal value) x 100. The following definitions will be used for assess the response. Complete response (CR) if the target lesion disappears; Partial response (PT) if the target lesion decreases at least 30%; Disease progression (DP) if the target lesion increases 20% or more. Stable disease (SD) if the lesion cannot be included in DP or PT categories. If the target lesion cannot be measure correctly it will be no gradable (NG).
    - MISO-PET to assess the tumor vascularization.
    - Assessment of tumor sample: 1.- Resection margins which could be R0, R1 or R2. 2.- Regression degree of the histological response by the following scale: (0) No tumor; (1) tumor cells, isolated tumor nests; (2) frequent tumor nests; (3) minimal response; (4) no response.
    - PET-TAC.- Se realizará 18FDG-PET-TAC para medir el SUV max (Standard Uptake Value max) de la lesión pancreática. Se seguirán criterios de la EORTC para la valoración de la respuesta por PET.
    - Respuesta de CA19.9
    - TAC de torax-abdomen-pelvis e incluirá contraste intravenoso. Se seguirán criterios RECIST 1.1. Para evaluar la respuesta : ((Valor posbasal ? valor basal)/valor basal) x 100. Respuesta completa (RC) si la lesión desaparece; Respuesta parcial (RP) si la lesión se reduce más de un 30%, Progresión de la enfermedad (PE) si la lesión aumenta al menos el 20%, Enfermedad estable (EE) si no llega a valores de PE ni RP. Si la lesión no se puede medir correctamente será no evaluable (NE).
    - MISO-PET para evaluar a vascularización del tumor
    - Valoración de la pieza tumoral: 1.- Borde de resección que puede evaluarse como R0, R1, R2. 2.- Grado de regresión de la respuesta histológica usando la siguiente escala: (0) No tumor; (1) Células, nidos tumorales aislados; (2) Nidos tumorales frecuentes; (3) Mínima respuesta; (4) Ausencia de respuesta
    E.5.2.1Timepoint(s) of evaluation of this end point
    PET-TAC, CA19.9 response, MISO-PET, Thorax-abdomen-pelvis TAC - Before and after treatment
    Assessment of tumor simple - After treatment
    PET-TAC, Respuesta de CA19.9, MISO-PET, TAC de tórax-abdomen-pelvis - Antes y después de los dos brazos de tratamiento
    Valoración de la pieza tumoral - Después del tratamiento
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months21
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    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
    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 Decision2014-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-04
    P. End of Trial
    P.End of Trial StatusOngoing
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