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    Clinical Trial Results:
    HEXVIX® VERUS WHITE LIGHT GUIDED TURB FOR EORTC SCORE INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER FOLLOWED BY ATTENUATED INTRAVESICAL ADJUVANT CHEMOTHERAPY.

    Summary
    EudraCT number
    		 2009-012275-98
    Trial protocol
    		 DE   AT  
    Global end of trial date
    30 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2022
    First version publication date
    03 Nov 2022
    Other versions
    Summary report(s)
    		 The Helena Study

    Trial information

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    Trial identification
    Sponsor protocol code
    HELENA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Regensburg
    Sponsor organisation address
    Franz-Josef-Strauss-Allee 11, Regensburg, Germany, 93053
    Public contact
    Dr. Josef Reisinger, multi-service-monitoring, 0049 9413782498, josef.reisinger@multi-service-monitoring.de
    Scientific contact
    Dr. Josef Reisinger, multi-service-monitoring, 0049 9413782498, josef.reisinger@multi-service-monitoring.de
    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
    17 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to compare the recurrence-free survival in patients with intermediate risk non-muscle invasive bladder cancer undergoing Hexvix® assisted transurethral resection of the bladder (TURB) and subsequently treated with one immediate intravesical chemotherapy instillation versus standard white-light TURB and subsequently treated with immediate and maintenance intravesical chemotherapy
    Protection of trial subjects
    see publication
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2010
    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
    Austria: 28
    Country: Number of subjects enrolled
    Germany: 101
    Worldwide total number of subjects
    129
    EEA total number of subjects
    129
    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)
    129
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total of 7 European University hospitals and tertiary medical centres, respectively (6 German and 1 Austrian) 247 patients were randomized from July 2010 to December 2016. Final analysis included 129 patients with intermediate risk non-muscle invasive bladder cancer.

    Pre-assignment
    Screening details
    		 Screening and Inclusion: • Cystoscopy report • Review of clinical files/history • Clinical examination • IV urography, ultrasound of the urinary tract or CT scan of upper urinary tract • Blood chemistry • Hematology • Urine analysis and culture in case of suspected infection • Urine pregnancy test for women of child-bearing age • Informed consent

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 WL-TURB
    Arm description
    		 WL-TURB with immediate intravesical chemotherapy followed by maintenance chemotherapy
    Arm type
    		 see above

    Investigational medicinal product name
    Mitomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    20 mg Mitomycin weekly for 6 weeks

    Arm title
    		 Hexvix Turb
    Arm description
    		 Patients in group 2 received Hexvix® TURB with immediate intravesical chemotherapy only
    Arm type
    		 see above

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		WL-TURB Hexvix Turb
    Started
    62
    67
    Completed
    62
    67

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    WL-TURB
    Reporting group description
    		 WL-TURB with immediate intravesical chemotherapy followed by maintenance chemotherapy

    Reporting group title
    Hexvix Turb
    Reporting group description
    		 Patients in group 2 received Hexvix® TURB with immediate intravesical chemotherapy only

    Reporting group values
    		 WL-TURB Hexvix Turb Total
    Number of subjects
    		 62 67 129
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 62 67 129
        85 years and over
    		 0 0 0
    Gender categorical
    hier text
    Units: Subjects
        Female
    		 13 15 28
        Male
    		 49 52 101
    Subject analysis sets

    Subject analysis set title
    test
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    hier text

    Subject analysis sets values
    		 test
    Number of subjects
    3
    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:
        
    ( )
    Gender categorical
    hier text
    Units: Subjects
        Female
    2
        Male
    2

    End points

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    End points reporting groups
    Reporting group title
    WL-TURB
    Reporting group description
    		 WL-TURB with immediate intravesical chemotherapy followed by maintenance chemotherapy

    Reporting group title
    Hexvix Turb
    Reporting group description
    		 Patients in group 2 received Hexvix® TURB with immediate intravesical chemotherapy only

    Subject analysis set title
    test
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    hier text

    Primary: RFS after 12 months

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    End point title
    		 RFS after 12 months [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 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: See attached document for results
    End point values
    		 WL-TURB Hexvix Turb
    Number of subjects analysed
    62
    67
    Units: whole
    62
    67
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    A total of 37 serious adverse events (SAEs) were documented throughout the trial whereas 6 were related to study treatment.
    Adverse event reporting additional description
    No diferences regarding number of SAEs, relationship to study treatment, severity or outcome were found between the treatment arms.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3
    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 attached document for results

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Feb 2016
    - removal of secondary endpoint: To demonstrate that Hexvix®-guided follow-up cystoscopy enhances detection of tumour recurrence as demonstrated by white-light cystoscopy followed by Hexvix®- guided cystoscopy in one patient serving as control (white-light cystoscopy) and case (Hexvix®-cystoscopy) and documentation of additional lesions visible by Hexvix®-cystoscopy in all patients regardless of treatment arm. - prolongation of inclusion period - prolongation of follow-up period

    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/34002265
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