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    Clinical Trial Results:
    PHASE II TRIAL OF PALLIATIVE EPIRUBICIN, OXALIPLATIN & CAPECITABINE (EOX) CHEMOTHERAPY COMBINED WITH OMEGA-3 FISH OIL INFUSION (OMEGAVEN) IN PATIENTS WITH OESOPHAGO-GASTRIC CARCINOMA

    Summary
    EudraCT number
    2011-003950-24
    Trial protocol
    GB  
    Global end of trial date
    31 Jul 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Mar 2019
    First version publication date
    20 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EOX1.4
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01870791
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University Hospitals of Leicester NHS Trust
    Sponsor organisation address
    Infirmary Square, Leicester, United Kingdom, LE1 5WW
    Public contact
    Prof David Bowrey, University Hospitals of Leicester NHS Trust, djb57@le.ac.uk
    Scientific contact
    Prof David Bowrey, University Hospitals of Leicester NHS Trust, djb57@le.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety profile of intravenous omega-3 fatty acid emulsion combined with standard palliative chemotherapy (EOX) in patients with incurable gastric or oesophageal carcinoma.
    Protection of trial subjects
    Review by study sponsor of safety profile of treatment after each participant
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    11
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment ran between 05/01/2012 and 07/31/2013

    Pre-assignment
    Screening details
    The study recruited adult patients referred to the University Hospitals of Leicester NHS Trust, UK with confirmed diagnoses of inoperable esophageal, gastroesophageal junctional or gastric adenocarcinoma, eligible for palliative chemotherapy. Treatment intent was determined at the weekly multi-disciplinary team meeting by the clinical team

    Pre-assignment period milestones
    Number of subjects started
    21
    Number of subjects completed
    21

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Palliative chemotherapy and Omegaven
    Arm description
    Participants received palliative chemotherapy with intravenous epirubicin (50 mg/m2) and oxaliplatin (130 mg/m2) every 21 days and oral capecitabine (1,250 mg/m2) daily for 21 days, in addition to Omegaven® as a once weekly at a rate of 2 ml/kg body weight for 4 hr
    Arm type
    Experimental

    Investigational medicinal product name
    Omegaven
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Omegaven®was infused once weekly at a rate of 2 ml/kg body weight for 4 hr

    Number of subjects in period 1
    Palliative chemotherapy and Omegaven
    Started
    21
    Completed
    20
    Not completed
    1
         Physician decision
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Palliative chemotherapy and Omegaven
    Reporting group description
    Participants received palliative chemotherapy with intravenous epirubicin (50 mg/m2) and oxaliplatin (130 mg/m2) every 21 days and oral capecitabine (1,250 mg/m2) daily for 21 days, in addition to Omegaven® as a once weekly at a rate of 2 ml/kg body weight for 4 hr

    Reporting group values
    Palliative chemotherapy and Omegaven Total
    Number of subjects
    21 21
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    67 (47 to 80) -
    Gender categorical
    Units: Subjects
        Female
    5 5
        Male
    16 16
    Subject analysis sets

    Subject analysis set title
    Palliative chemotherapy and Omegaven
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Patients receiving palliative EOX chemotherapy and weekly Omegaven infusion

    Subject analysis sets values
    Palliative chemotherapy and Omegaven
    Number of subjects
    21
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    67 (47 to 80)
    Gender categorical
    Units: Subjects
        Female
    5
        Male
    16

    End points

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    End points reporting groups
    Reporting group title
    Palliative chemotherapy and Omegaven
    Reporting group description
    Participants received palliative chemotherapy with intravenous epirubicin (50 mg/m2) and oxaliplatin (130 mg/m2) every 21 days and oral capecitabine (1,250 mg/m2) daily for 21 days, in addition to Omegaven® as a once weekly at a rate of 2 ml/kg body weight for 4 hr

    Subject analysis set title
    Palliative chemotherapy and Omegaven
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Patients receiving palliative EOX chemotherapy and weekly Omegaven infusion

    Primary: Safety profile of Omegaven

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    End point title
    Safety profile of Omegaven [1]
    End point description
    To assess the effect, tolerability (side effects) and feasibility of use (number of participants requiring dose delays and/or treatment withdrawal)
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a proof of principle trial, primarily assessing the safety profile of Omegaven in this patient participant group.
    End point values
    Palliative chemotherapy and Omegaven
    Number of subjects analysed
    Units: adverse events
    20
    No statistical analyses for this end point

    Secondary: Radiological response rate

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    End point title
    Radiological response rate
    End point description
    Objective response rate as assessed by RECIST criteria
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    Palliative chemotherapy and Omegaven
    Number of subjects analysed
    15
    Units: RECIST criteria
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any adverse event observed during the study period was reported to the study sponsor
    Adverse event reporting additional description
    Adverse events were reported according to the CTCAE v 4.03
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Palliative chemotherapy and Omegaven
    Reporting group description
    Participants received palliative chemotherapy with intravenous epirubicin (50 mg/m2) and oxaliplatin (130 mg/m2) every 21 days and oral capecitabine (1,250 mg/m2) daily for 21 days, in addition to Omegaven® as a once weekly at a rate of 2 ml/kg body weight for 4 hr

    Serious adverse events
    Palliative chemotherapy and Omegaven
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Palliative chemotherapy and Omegaven
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 20 (85.00%)
    Immune system disorders
    Grade 3 or 4 chemotherapy related toxicities
    Additional description: All grade 3 or 4 chemotherapy related toxicities were recorded, and these are presented below (the commonest was neutropenia)
         subjects affected / exposed
    17 / 20 (85.00%)
         occurrences all number
    17

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/30711967
    http://www.ncbi.nlm.nih.gov/pubmed/27342748
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