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    Clinical Trial Results:
    Intraoperative intraperitoneal chemoperfusion to treat peritoneal minimal residual disease in stage III ovarian cancer: a randomized phase II trial.

    Summary
    EudraCT number
    		 2015-000418-23
    Trial protocol
    		 BE  
    Global end of trial date
    25 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jun 2024
    First version publication date
    06 Jun 2024
    Other versions
    Summary report(s)
    		 Final Study Report
    Protocol
    ClinicalTrials.gov
    Summary attachment

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2015/002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Ghent
    Sponsor organisation address
    C. Heymanslaan 10, Gent, Belgium, 9000
    Public contact
    Bimetra Clinics, Ghent University Hospital, +32 93320500, bimetra.clinics@uzgent.be
    Scientific contact
    Bimetra Clinics, Ghent University Hospital, +32 93320500, bimetra.clinics@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
    25 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the effect of cytoreductive surgery (CRS) and efficacy of cisplatin-based intraoperative intraperitoneal chemoperfusion (IPEC) in patients with primary or recurrent serous epithelial ovarian cancer (OC), in order to treat peritoneal minimal residual disease (pMRD).
    Protection of trial subjects
    See attachment Final Status Report
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2016
    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: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 See attachement Final Study Report

    Pre-assignment
    Screening details
    		 See attachement Final Study Report

    Period 1
    Period 1 title
    Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 low dose, normothermic
    Arm description
    		 CRS + normothermic (37°C) intraoperative intraperitoneal chemoperfusion, with 100mg/m² Cisplatin during 90min + adjuvant chemotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPEC with Cisplatin (75mg/m²)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for intravesical solution
    Routes of administration
    Other use
    Dosage and administration details
    See attachements

    Arm title
    		 high dose, normothermic
    Arm description
    		 CRS + normothermic (37°C) intraoperative intraperitoneal chemoperfusion, with 75mg/m² Cisplatin during 90min + adjuvant chemotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPEC with Cisplatin (100mg/m²)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    Intraperitoneal normotherm (37°C) administration of Cisplatin (100mg/m²), during 90min

    Arm title
    		 low dose, hyperthermic
    Arm description
    		 CRS + hyperthermic (41°C) intraoperative intraperitoneal chemoperfusion, with 75mg/m² Cisplatin during 90min + adjuvant chemotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hypertherm IntraPEritoneal Chemotherapy with Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    Intraperitoneal hypertherm (41°C) administration of Cisplatin (75mg/m²), during 90min

    Arm title
    		 high dose, hyperthermic
    Arm description
    		 CRS + hyperthermic (41°C) intraoperative intraperitoneal chemoperfusion, with 100mg/m² Cisplatin during 90min + adjuvant chemotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    HIPEC with Cisplatin (100mg/m²)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Other use
    Dosage and administration details
    Intraperitoneal hypertherm (41°C) administration of Cisplatin (100mg/m²), during 90min

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: zie attachments
    Number of subjects in period 1 [2]
    		low dose, normothermic high dose, normothermic low dose, hyperthermic high dose, hyperthermic
    Started
    16
    12
    13
    13
    Completed
    16
    12
    13
    13
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: see attachments

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    low dose, normothermic
    Reporting group description
    		 CRS + normothermic (37°C) intraoperative intraperitoneal chemoperfusion, with 100mg/m² Cisplatin during 90min + adjuvant chemotherapy

    Reporting group title
    high dose, normothermic
    Reporting group description
    		 CRS + normothermic (37°C) intraoperative intraperitoneal chemoperfusion, with 75mg/m² Cisplatin during 90min + adjuvant chemotherapy

    Reporting group title
    low dose, hyperthermic
    Reporting group description
    		 CRS + hyperthermic (41°C) intraoperative intraperitoneal chemoperfusion, with 75mg/m² Cisplatin during 90min + adjuvant chemotherapy

    Reporting group title
    high dose, hyperthermic
    Reporting group description
    		 CRS + hyperthermic (41°C) intraoperative intraperitoneal chemoperfusion, with 100mg/m² Cisplatin during 90min + adjuvant chemotherapy

    Primary: Primary

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    End point title
    		 Primary [1]
    End point description
    End point type
    Primary
    End point timeframe
    1 tumor nodule will be immediately fixed in liquid nitrogen after cytoreductive surgery and chemoperfusion. Frozen sections will be ablated through study completion
    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: See attachments
    End point values
    		 low dose, normothermic high dose, normothermic low dose, hyperthermic high dose, hyperthermic
    Number of subjects analysed
    16
    12
    13
    13
    Units: LA-ICP-MS
        number (not applicable)
    16
    12
    13
    13
    No statistical analyses for this end point

    Secondary: Secondary

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    End point title
    		 Secondary
    End point description
    End point type
    Secondary
    End point timeframe
    Surgical morbidity and mortality will be measured using Dindo-Clavien classification This will be estimated with the Dindo-Clavien classification [Time Frame: Within 30 days after surgery and intraoperative intraperitoneal chemoperfusion] Cancer-spec
    End point values
    		 low dose, normothermic high dose, normothermic low dose, hyperthermic high dose, hyperthermic
    Number of subjects analysed
    16
    12
    13
    13
    Units: Subjects
    16
    12
    13
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: See attachments

    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
    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.

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