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    Summary
    EudraCT Number:2013-001630-18
    Sponsor's Protocol Code Number:INOX-EGJ
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-06-20
    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 number2013-001630-18
    A.3Full title of the trial
    Multicentre phase 2 study of neoadjuvant oxaliplatin and capecitabine followed by chemo-radiotherapy in patients with locally advanced carcinoma of esphago-gastric junction.
    Studio multicentrico di fase II, di chemioterapia di induzione con Oxaliplatino e Capecitabina seguito da chemio-radioterapia con intento neoadiuvante in pazienti affetti da carcinoma della giunzione esofago-gastrica localmente avanzato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicentre phase 2 study of neoadjuvant oxaliplatin and capecitabine followed by chemo-radiotherapy in patients with locally advanced carcinoma of esphago-gastric junction.
    Studio multicentrico di fase II, di chemioterapia di induzione con Oxaliplatino e Capecitabina seguito da chemio-radioterapia con intento neoadiuvante in pazienti affetti da carcinoma della giunzione esofago-gastrica localmente avanzato.
    A.3.2Name or abbreviated title of the trial where available
    INduction Oxaliplatin and Xeloda in Esophago-Gastric Junction cancer
    A.4.1Sponsor's protocol code numberINOX-EGJ
    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 SponsorIstituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione “G.Pascale”
    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 supportnone
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione “G.Pascale”
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street Addressvia M. Semmola
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number+390815903571
    B.5.5Fax number+390817702938
    B.5.6E-mailmarilina.piccirillo@usc-intnapoli.net
    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.2.1.2Country 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 nameoxaliplatin
    D.3.4Pharmaceutical form Powder 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/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number130
    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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    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 namecapecitabine
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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
    Locally advanced carcinoma (squamous or adenocarcinoma) of the esophago-gastric junction Siewert type I and II
    Carcinoma (adenocarcinoma o carcinoma squamoso) della giunzione esofago-gastrica tipo I e II secondo Siewert localmente avanzato
    E.1.1.1Medical condition in easily understood language
    Locally advanced esophago-gastric junction carcinoma
    Carcinoma della giunzione esofago-gastrica 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10056267
    E.1.2Term Gastroesophageal cancer
    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 activity in terms of pathological complete response rate (pCR) of a neoadjuvant treatment with XELOX followed by chemo-RT in patients with locally advanced (stage IB-III) carcinoma of the esophagogastric junction .
    Valutare l’attività in termini di percentuale di risposte complete patologiche (pCR) di un trattamento ad intento neoadiuvante con XELOX seguito da chemio-RT in pazienti affetti da carcinoma della giunzione esofago-gastrica localmente avanzato (stadio IB-III).
    E.2.2Secondary objectives of the trial
    • To evaluate:
    objective response rate
    toxicity
    rate of R0 resections
    progression-free survival (PFS)
    overall survival (OS)

    • To validate the predictive role of early metabolic changes of the tumor measured by PET / CT
    • To evaluate the prognostic role of the immunocompetent cell subsets CD4, CD8, CD20, CD57, CD68
    • Valutare:
    o tasso di risposte obiettive
    o tossicità
    o tasso di resezioni R0
    o sopravvivenza libera da progressione (PFS)
    o sopravvivenza globale (OS)

    • Validare il ruolo predittivo dei cambiamenti metabolici precoci a carico della neoplasia misurati con esame PET/TC
    • Valutare il ruolo prognostico di sottopopolazioni cellulari immunocompetenti CD4, CD8, CD20, CD57, CD68
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria

    - Carcinoma of the esophagogastric junction Siewert type I and II locally advanced (T2-3-4, N +) documented by histology and / or cytology
     Age ≥ 18 and ≤ 75 years
     Presence of at least one target lesion according to RECIST
     Performance Status ECOG = 0-1
     Adequate bone marrow , hepatic and renal function
     Estimated life expectancy> 3 months
     Written informed consent
























     Carcinoma of the esophagogastric junction Siewert type I and II sec locally advanced (T2-3-4, N +) documented by histology and / or cytology
     Age ≥ 18 years and ≤ 75 years
     Presence of measurable target lesions according to RECIST
     Performance Status ECOG = 0-1
     Lack of significant changes in bone marrow function, hepatic and renal
     estimated life expectancy> 3 months
     Written informed consent























     Carcinoma della giunzione esofago-gastrica tipo I e II sec Siewert localmente avanzato (T2-3-4, N+) documentato mediante esame istologico e/o citologico
     Età ≥ 18 anni e ≤ 75 anni
     Presenza di lesioni target misurabili secondo i criteri RECIST
     Performance Status secondo ECOG = 0-1
     Assenza di rilevanti alterazioni della funzionalità midollare, epatica e renale
     Aspettativa di vita stimata > 3 mesi
     Consenso informato scritto
    E.4Principal exclusion criteria

     Distant metastases
     Previous systemic medical treatment or radiotherapy for neoplastic disease
     Presence of concomitant and / or previous malignancies
     Presence of acute or chronic infectious states requiring systemic medical therapies.
     Significant cardiovascular disease (myocardial infarction, unstable angina, congestive heart failure, arrhythmias) occurred less than 18 months prior to the enrollment
     Cerebro-vascular disorders
     Venous or arterial thromboembolism in place
     Severe respiratory diseases
     Inflammatory Bowel diseases
     Known Seropositivity for HIV
     Acute or chronic HBV or HCV hepatitis
     Peripheral neuropathy of any etiology
     Hepatic or renal impairment
     Any other clinically significant systemic disease that can make the patient unsuitable for study treatment
    - Major surgery ​​less than 28 days, or minor surgical procedure practiced less than 14 days before the start of treatment (excluding the placement of CVC)
     Pregnant or breastfeeding
     Dementia or other significant condition of altered mental status that may affect the ability of understanding of the scope of the study by the patient and the proper granting of informed consent
     Metastasi a distanza
     Precedente trattamento medico sistemico o radioterapico per la malattia neoplastica
     Presenza di concomitanti e/o pregresse neoplasie maligne
     Presenza di stati infettivi acuti o cronici richiedenti terapie mediche sistemiche.
     Significative patologie cardiovascolari (infarto del miocardio, angina instabile, scompenso cardiaco congestizio, aritmie) occorse meno di 18 mesi prima dell’eventuale arruolamento
     Patologie cerebro-vascolari
     Tromboembolie venose o arteriose in atto
     Gravi patologie respiratorie
     Malattie infiammatorie croniche intestinali
     Sieropositività conosciuta per HIV
     Epatite acuta o cronica da HBV o HCV
     Neuropatia periferica di qualsiasi eziologia
     Insufficienza epatica o renale
     Qualsiasi altra patologia sistemica clinicamente rilevante che si ritenga possa rendere il paziente inidoneo al trattamento in studio
     Intervento di chirurgia maggiore effettuato meno di 28 giorni oppure procedura chirurgica minore praticata meno di 14 giorni prima dell’inizio del trattamento (escluso il posizionamento di CVC)
     Stato di gravidanza o allattamento
     Demenza o altra significativa condizione di alterazione dello stato mentale che possa inficiare la capacità di comprensione degli scopi dello studio da parte del paziente e la corretta concessione del consenso informato da parte dello stesso
    E.5 End points
    E.5.1Primary end point(s)
    rate of complete pathologic response
    tasso di risposte patologiche complete
    E.5.1.1Timepoint(s) of evaluation of this end point
    surgery (about 21 weeks from study start)
    intervento chirurgico (circa 21 settimane dalla randomizzazione)
    E.5.2Secondary end point(s)
    objective response rate
    toxicity
    R0 resection rate
    PFS
    OS
    tasso di risposte obiettive; tossicità; tasso di resezioni R0; sopravvivenza libera da progressione (PFS); sopravvivenza globale (OS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    objective response rate: week 20
    toxicity: every week
    R0 resection rate: surgery (about week 21)
    PFS: week 20 and every 3 months later
    OS. death
    tasso di risposte obiettive: settimana 20
    tossicità: ogni settimana
    tasso di resezioni R0: intervento chirurgico (circa 21 settimane dopo la randomizzazione)
    sopravvivenza libera da progressione: settimana 20 e successivamente ogni 3 mesi
    sopravvivenza globale: decesso
    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.8.3 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 concerned10
    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 years3
    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.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state40
    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)
    not different from clinical practice for this condition
    non diverso dalla pratica clinica per la specifica condizione
    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 Decision2013-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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