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    Summary
    EudraCT Number:2016-000696-25
    Sponsor's Protocol Code Number:FOLRT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-000696-25
    A.3Full title of the trial
    INDUCTION FOLFIRINOX AND RADIOCHEMOTHERAPY IN LOCALLY ADVANCED PANCREATIC ADENOCARCINOMA
    FOLFIRINOX DI INDUZIONE E
    RADIO-CHEMIOTERAPIA CONCOMITANTE
    NELL¿ADENOCARCINOMA DEL PANCREAS LOCALMENTE AVANZATO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INDUCTION CHEMOTHERAPY FOLLOWED BY RADIOCHEMOTHERAPY IN PANCREATIC ADENOCARCINOMA
    CHEMIOTERAPIA DI INDUZIONE E RADIOCHEMIOTERAPIA NEL TRATTAMENTO DEL CARCINOMA PANCREATICO LOCALMENTE AVANZATO
    A.3.2Name or abbreviated title of the trial where available
    FOLRT
    FOLRT
    A.4.1Sponsor's protocol code numberFOLRT
    A.5.4Other Identifiers
    Name:FOLRTNumber:FOLRT
    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 SponsorUNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
    B.1.3.4CountryItaly
    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 supportUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.5.2Functional name of contact pointU.O. DI RADIOTERAPIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA ALVARO DEL PORTILLO 200
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00128
    B.5.3.4CountryItaly
    B.5.4Telephone number06225418080
    B.5.5Fax number06225411989
    B.5.6E-mailm.fiore@unicampus.it
    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 FLUOROURACILE TEVA - 5 G/100 ML SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 100 ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUOROURACILE
    D.3.9.1CAS number 51-21-8
    D.3.9.2Current sponsor code120915
    D.3.9.3Other descriptive nameFLUOROURACILE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 GEMBIN - 40 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 25 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS ITALY S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameGEMCITABINA
    D.3.4Pharmaceutical form 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 INNGEMCITABINA CLORIDRATO
    D.3.9.1CAS number 95058-81-4
    D.3.9.2Current sponsor code120915
    D.3.9.3Other descriptive nameGEMCITABINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 OXALIPLATINO KABI - 5 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 20 ML
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI ONCOLOGY PLC
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameOXALIPLATINO
    D.3.2Product code 39170028
    D.3.4Pharmaceutical form 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 INNOXALIPLATINO
    D.3.9.1CAS number 63121-00-6
    D.3.9.2Current sponsor code120915
    D.3.9.3Other descriptive nameOxaliplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number85
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 MYLAN GENERICS - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 25 ML
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameIRINOTECANO
    D.3.4Pharmaceutical form 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 CLORIDRATO TRIIDRATO
    D.3.9.1CAS number 100286-90-6
    D.3.9.2Current sponsor code120915
    D.3.9.3Other descriptive nameIrinotecan
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 CALCIO LEVOFOLINATO TEVA - 175 MG POLVERE PER SOLUZIONE PER INFUSIONE 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameCALCIO LEVOFOLINATO
    D.3.4Pharmaceutical form 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 INNCALCIO LEVOFOLINATO
    D.3.9.1CAS number 1492-18-8
    D.3.9.2Current sponsor code120915
    D.3.9.3Other descriptive nameLEVOFOLINATE CALCIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 FLUOROURACILE TEVA - 5 G/100 ML SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 100 ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namefluorouracile
    D.3.4Pharmaceutical form Powder and solvent 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 INNFLUOROURACILE
    D.3.9.1CAS number 51-21-8
    D.3.9.2Current sponsor code120915
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    LOCALLY ADVANCED PANCREATIC CANCER
    NEOPLASIA DEL PANCREAS LOCALMENTE AVANZATA
    E.1.1.1Medical condition in easily understood language
    LOCALLY ADVANCED PANCREATIC CANCER
    TUMORE DEL PANCREAS IN STADIO LOCALMENTE AVANZATO
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001141
    E.1.2Term Adenocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    FEASIBILITY AND EFFICACY OF THE TREATMENT
    FATTIBILITA' ED EFFICACIA DEL TRATTAMENTO
    E.2.2Secondary objectives of the trial
    SURVIVAL AND RESPONSE RATE
    SOPRAVVIVENZA E RISPOSTE OBIETTIVE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Only patients that met the following inclusion criteria were included in the treatment protocol: proven cytological or histological diagnosis of PDAC; age between 18 and 75 years; no previous RCT; 0-I ECOG performance status; adequate cardiac, liver and kidney function and a good bone marrow reserve. Patients were included if they had borderline resectable or unresectable pancreatic tumours.
    1) diagnosi cito-istologica di adenocarcinoma del pancreas;
    2) valutazione della resecabilità rispettando i seguenti principi:
    - assenza di metastasi a distanza
    - assenza di diffusione peritoneale
    - grado di coinvolgimento vascolare (stadio T3/T4)
    3) nessun trattamento precedente chemioterapico o radioterapico del distretto addominale;
    4) età compresa tra i 18 ed i 75 anni;
    5) performance status = 0-I (ECOG);
    6) assenza di patologie cardiovascolari che controindichino il trattamento; in particolare assenza di insufficiente compenso emodinamico, ipertensione severa incontrollata (PA diastolica > 95 mmHg), aritmie oltre il grado II (WHO), ed in ogni caso cardiopatia ¿ Classe II NYHA;
    7) adeguata riserva midollare: neutrofili > 2.0 x 103/L, piastrine > 100 x 103/L, emoglobina > 10 g/dl;
    8) adeguata funzione renale: creatininemia < 1.5 mg/dl, azotemia < 1.5 volte il limite superiore massimo. La valutazione della clearance della creatinina sarà effettuata per valori di creatinina > 1.5 mg/dl. I pazienti sono eleggibili se i valori della clearance della creatinina > 40 ml/mn;
    9) adeguata funzione epatica: ASAT < 2 volte il limite superiore massimo;
    10) assenza d’infezioni incontrollate in atto;
    11) assenza di stato di gravidanza e/o d’allattamento; l’assenza dello stato di gravidanza, nelle donne in età fertile, dovrà essere dimostrato dalla negatività di un generico test di gravidanza, eseguito non oltre 72 ore prima dell’inizio del trattamento;
    12) consenso informato scritto.
    E.4Principal exclusion criteria
    The exclusion criteria were: resectable and metastatic disease; previous or concomitant malignant disease; one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, Pa O2¿<¿65 mmHg, Pa CO2¿>¿40 mmHg, mental disability.
    1) esame istologico negativo per adenocarcinoma del pancreas;
    2) presenza di carcinosi peritoneale;
    3) presenza di metastasi a distanza;
    4) precedente trattamento chemioterapico o radioterapico del distretto addominale;
    5) età < 18 o > 75 anni;
    6) performance status = 2 (ECOG);
    7) altre patologie neoplastiche pregresse e/o concomitanti o gravi malattie concomitanti e/o intercorrenti anche di tipo psichiatrico;
    8) presenza di cardiopatia in fase attiva: insufficiente compenso emodinamico, ipertensione incontrollata, aritmie superiori al grado II WHO; scompenso cardiaco > Classe II NYHA; presenza di insufficienza respiratoria totale;
    9) inadeguata riserva midollare: conta assoluta dei neutrofili < 2000/ mm3, piastrine <100.000 mm3, emoglobina <10 g/dl;
    10) inadeguata funzione renale: creatininemia > 1.5 mg/dl, azotemia > 1.5 volte il limite superiore massimo. I pazienti sono ineleggibili se i valori della clearance della creatinina < 40 ml/min;
    11) inadeguata funzione epatica: ASAT > 2 volte il limite superiore massimo;
    12) Pa O2 < 65 mmHg; Pa CO2 > 40 mmHg;
    13) infezioni incontrollate in atto;
    14) stato di gravidanza e/o di allattamento;
    15) assenza di consenso informato scritto;
    16) infermità mentale.
    E.5 End points
    E.5.1Primary end point(s)
    FEASIBILITY
    FATTIBILITA'
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 MONTHS
    18 MESI
    E.5.2Secondary end point(s)
    EFFICACY (SURVIVAL AND RESPONSE RATE)
    EFFICACIA (SOPRAVVIVENZA E TASSO DI RISPOSTE OBIETTIVE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 MONTHS
    18 MESI
    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 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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days73
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days73
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    STANDARD OF CARE
    STANDARD OF CARE
    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 Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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