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    Clinical Trial Results:
    Neoadjuvant short-term Intensive Chemoresection versus Standard Adjuvant intravesical instillations in NMIBC - A study on effect and tolerability of neoadjuvant short-term intensive chemoresection and molecular markers for prediction of chemo-response

    Summary
    EudraCT number
    		 2017-001189-98
    Trial protocol
    		 DK  
    Global end of trial date
    01 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2026
    First version publication date
    04 Jan 2026
    Other versions
    Summary report(s)
    		 NICSA summary

    Trial information

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    Trial identification
    Sponsor protocol code
    NICSA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03348969
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 82, Aarhus N, Denmark, 8200
    Public contact
    Jørgen Bjerggaard Jensen, Aarhus Universitets Hospital, 0045 78452617, Bjerggaard@skejby.rm.dk
    Scientific contact
    Jørgen Bjerggaard Jensen, Aarhus Universitets Hospital, 0045 78452617, Bjerggaard@skejby.rm.dk
    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
    10 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to assess the efficacy of a neoadjuvant, short-term, intensive intravesical chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation therapy. We hypothesize that the chemoresection induced in the short-term, intensive intravesical instillation with Mitomycin C will result in a permanent low recurrence rate in patients with NMIBC, not significantly different from patients treated with TURB and standard adjuvant instillation therapy. We also hypothesize that a reduction in number of TURBs will be seen in the intervention group based on avoidance of TURBs in patients with complete chemoresection by the short-term, intensive intravesical instillations.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Oct 2017
    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
    Denmark: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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
    96
    85 years and over
    23

    Subject disposition

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    Recruitment
    Recruitment details
    		 120 participants were enrolled in the study. 1 participant withdrew from the study prior to commencing study related activities or treatment.

    Pre-assignment
    Screening details
    		 357 potential candidates were screened for participation. Participants with a history of Ta low- or high-grade NMIBC were candidates for the study upon recurrence.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Chemoablation
    Arm description
    		 The intervention group received intravesical MMC (40 mg/40 mL) three times a week for 2 weeks and TURBT or office biopsy only if the response was incomplete.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mitomycin C Medac
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravesical solution
    Routes of administration
    Intravesical use
    Dosage and administration details
    40 mg/40 mL mitomycin C, intravesically three times per week for 2 weeks

    Arm title
    		 Control
    Arm description
    		 The control group received TURBT or office biopsy and 6 weekly adjuvant instillations.
    Arm type
    		 Standard of care

    Investigational medicinal product name
    Mitomycin C Medac
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravesical solution
    Routes of administration
    Intravesical use
    Dosage and administration details
    40 mg/40 mL mitomycin C, intravesically once per week for 6 weeks

    Number of subjects in period 1
    		Chemoablation Control
    Started
    59
    61
    End of recruitment
    59
    61
    Completed
    56
    52
    Not completed
    3
    9
         Consent withdrawn by subject
    1
    -
         benign pathology
    -
    2
         patient refusal
    -
    4
         comorbidities
    -
    1
         side effects
    2
    2

    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
    		 120 120
    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
    		 96 96
        85 years and over
    		 23 23
    Age continuous
    control group: 70(65-76) Chemoablation group: 72(66-77)
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 71 (65 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 34 34
        Male
    		 86 86
    Number of Tumours at inclusion
    Units: Subjects
        2-7
    		 98 98
        >8
    		 22 22
    Tumour size, mm
    Units: Subjects
        <5
    		 55 55
        6-10
    		 35 35
        11-20
    		 19 19
        21-30
    		 5 5
        >30
    		 2 2
        not specified
    		 4 4
    Previous BCG treatment
    Units: Subjects
        Yes
    		 13 13
        No
    		 107 107
    Histology before inclusion
    Units: Subjects
        Low Grade
    		 85 85
        High Hrade
    		 35 35

    End points

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    End points reporting groups
    Reporting group title
    Chemoablation
    Reporting group description
    		 The intervention group received intravesical MMC (40 mg/40 mL) three times a week for 2 weeks and TURBT or office biopsy only if the response was incomplete.

    Reporting group title
    Control
    Reporting group description
    		 The control group received TURBT or office biopsy and 6 weekly adjuvant instillations.

    Primary: Procedures

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    End point title
    		 Procedures
    End point description
    End point type
    Primary
    End point timeframe
    5-year follow-up period
    End point values
    		 Chemoablation Control
    Number of subjects analysed
    59
    61
    Units: procedures
    number (not applicable)
        Procedures
    10
    0
        TURBT
    37
    54
    Statistical analysis title
    		 Chi-squared
    Statistical analysis description
    procedure rates
    Comparison groups
    Chemoablation v Control
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: 5 year recurrence free survival

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    End point title
    		 5 year recurrence free survival
    End point description
    5 year Recurrence free survival (RFS)
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    		 Chemoablation Control
    Number of subjects analysed
    59
    61
    Units: patients
    number (confidence interval 95%)
        5 year RFS
    14 (7 to 27)
    28 (18 to 42)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All participants of the study, who receive intravesical treatment with Mitomycin C, will be interviewed in order to describe side effects and adverse events associated with the treatment. Interviews will be conducted using templates from the national
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    overall
    Reporting group description
    		 -

    Serious adverse events
    		 overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 119 (0.00%)
         number of deaths (all causes)
    13
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 119 (50.42%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Dysuria
         subjects affected / exposed
    47 / 119 (39.50%)
         occurrences all number
    47
    Pollakiuria
         subjects affected / exposed
    60 / 119 (50.42%)
         occurrences all number
    60
    Palmar erythema
         subjects affected / exposed
    12 / 119 (10.08%)
         occurrences all number
    12
    Cystitis
         subjects affected / exposed
    8 / 119 (6.72%)
         occurrences all number
    8
    Haematuria
         subjects affected / exposed
    18 / 119 (15.13%)
         occurrences all number
    18
    Incontinence
         subjects affected / exposed
    25 / 119 (21.01%)
         occurrences all number
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 May 2020
    amendment approved for additional analysis methods
    04 Jan 2021
    change of follow-up to follow national standards

    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.
    Relatively small sample size, few HG tumors, and RFS assessed as a secondary endpoint with unblinded cystoscopy, short MMC chemoresection without maintenance and inclusion of fulgurations without biopsy.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32736928
    http://www.ncbi.nlm.nih.gov/pubmed/36223555
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    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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