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    Clinical Trial Results:
    behandling af patienter med avanceret rectumcancer med capecitabin og oxaliplatin før under og efter kurativt intenderet strålebehandling, samt tillæg af cetuximab til patienter der er K-RAS vild-type

    Summary
    EudraCT number
    		 2009-010976-94
    Trial protocol
    		 DK  
    Global end of trial date
    11 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    gi0901
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00964457
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Herlev Ringvej 75, Herlev, Denmark, 2730
    Public contact
    Finn Ole Larsen, Department of Oncolocgy Herelv Hospital, +45 38682329, finn.ole.larsen@regionh.dk
    Scientific contact
    Finn Ole Larsen, Department of Oncolocgy Herelv Hospital, +45 38682329, finn.ole.larsen@regionh.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
    11 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    evaluate response to the treatment
    Protection of trial subjects
    Eligibility criteria and standard safety monitoring
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    26
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient were recruited at single site (Herlev Hospital) in Denmark from Aug 2009 to Jun 2012

    Pre-assignment
    Screening details
    		 Rectum cancer T3 or T4, performance status 0-1

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    open label trial without comparator arm

    Arms
    Arm title
    		 Study treatment
    Arm description
    		 Capecitabine + Oxaliplatin + radiation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    650 mg /m2 x 2 daily (16 weeks)

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m2 every 2 weeks ( 6 weeks before and 4 weeks after radiation), during radiation the dose was 50 mg/m2 every week (6 weeks)

    Number of subjects in period 1
    		Study treatment
    Started
    52
    Completed
    51
    Not completed
    1
         Adverse event, serious fatal
    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
    		 52 52
    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))
    		 65 (41 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 31 31

    End points

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    End points reporting groups
    Reporting group title
    Study treatment
    Reporting group description
    		 Capecitabine + Oxaliplatin + radiation

    Primary: Response rate

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    End point title
    		 Response rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    At end of treatment (16 weeks)
    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: Phase 2 design of trial, without comperator
    End point values
    		 Study treatment
    Number of subjects analysed
    52
    Units: number of patients
        CR
    0
        PR
    34
        SD
    2
        PD
    0
        Not assesable
    16
    No statistical analyses for this end point

    Secondary: Overall survival rate

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    End point title
    		 Overall survival rate
    End point description
    End point type
    Secondary
    End point timeframe
    5 years after treatment start
    End point values
    		 Study treatment
    Number of subjects analysed
    52
    Units: percent
    65
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment start to 30 days after last treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Study treatment
    Reporting group description
    		 Capecitabine + Oxaliplatin + radiation

    Serious adverse events
    		 Study treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 52 (1.92%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Study treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 52 (44.23%)
    Nervous system disorders
    Neurotoxicity
    Additional description: grade 3
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
    Additional description: grade 3
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhoea
    Additional description: grade 3 and grade 4
         subjects affected / exposed
    12 / 52 (23.08%)
         occurrences all number
    12
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
    Additional description: grade 3
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences all number
    3

    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.
    NA

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27743742
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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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