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    Clinical Trial Results:
    Catheter based adjuvant intraperitoneal chemotherapy for carcinomatosis.

    Summary
    EudraCT number
    2014-000882-34
    Trial protocol
    BE  
    Global end of trial date
    12 Nov 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jul 2021
    First version publication date
    28 Jul 2021
    Other versions
    Summary report(s)
    Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2014/002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, University Hospital Ghent, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, University Hospital Ghent, +32 93320500, hiruz.ctu@uzgent.be
    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
    12 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the feasibility and safety of adjuvant, catheter based intraperitoneal chemotherapy in patients with minimal residual disease after cytoreductive surgery for carcinomatosis from GI origin.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    1
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    2 patients were screened from 05-06-2014 till 12-11-2015. 2 patients were enrolled and randomised. 0 patients were included and completed the trial. End of trial notification was dated 12-11-2015 (last patient last visit) and submitted to EC and CA 12/12/2017.

    Pre-assignment
    Screening details
    INCLUSION CRITERIA: Peritoneal carcinomatosis from GI origin (appendix, colon, small bowel, stomach) - Resectable disease - No or minimal systemic or extra-abdominal disease or metastatic spread - Written informed consent

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Baseline
    Arm description
    Baseline data for the study, as the study only has 1 arm.
    Arm type
    Baseline arm

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Treatment
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    5-fluorouracil
    Investigational medicinal product code
    Other name
    Fluracedyl
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    5-fluorouracil 600 mg/m2 biweekly, total of 9 cycles

    Number of subjects in period 1
    Baseline Treatment
    Started
    2
    2
    Completed
    2
    0
    Not completed
    0
    2
         Adverse event, serious fatal
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Reporting group values
    Overall Trial Total
    Number of subjects
    2 2
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    1 1
        From 65-84 years
    1 1
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    2 2

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    Baseline data for the study, as the study only has 1 arm.

    Reporting group title
    Treatment
    Reporting group description
    -

    Primary: termination of IP chemotherapy due to complications or adverse events.

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    End point title
    termination of IP chemotherapy due to complications or adverse events. [1]
    End point description
    End point type
    Primary
    End point timeframe
    Until end oif treatment due to complications or adverse events
    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: No statistical analysis available.
    End point values
    Baseline Treatment
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: N/A
    Notes
    [2] - Baseline arm.
    [3] - Drop-out of patients.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Baseline
    Reporting group description
    Baseline data for the study, as the study only has 1 arm.

    Reporting group title
    Treatment
    Reporting group description
    Treatment arm that received 5-fluorouracil (Fluracedyl) 600 mg/m2 intraperitoneal.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were recorded for the participating patients.
    Serious adverse events
    Baseline Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    exploratieve laparotomy: surgical stenting
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Death
    Additional description: Disease progression - rapidly failing health - death
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Baseline Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)

    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.
    2 patients prematurely discontinued. Only 2 patients were included because the potential number of suitable candidates that could be a candidate for this therapy was overestimated.
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