Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 14:09:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA