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    Clinical Trial Results:
    Radiosensitizing Chemotherapy (Irinotecan) with Stereotactic Body Radiation Therapy for the Treatment of Inoperable Liver and/or Lung Metastases of Colorectal Cancer

    Summary
    EudraCT number
    		 2006-005440-87
    Trial protocol
    		 FR  
    Global end of trial date
    31 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2022
    First version publication date
    29 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BRD 06/9-R
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01220063
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    INSTITUT DE CANCEROLOGIE DE L'OUEST
    Sponsor organisation address
    15 rue André Boquel, ANGERS 02, France, 49055
    Public contact
    Marine TIGREAT, INSTITUT DE CANCEROLOGIE DE L'OUESTT, +33 240679747, promotionrc@ico.unicancer.fr
    Scientific contact
    Marine TIGREAT, INSTITUT DE CANCEROLOGIE DE L'OUEST, +33 240679747, promotionrc@ico.unicancer.fr
    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
    30 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary outcome was the objective local response rate as per RECIST 1.0.
    Protection of trial subjects
    The sponsor contracted with insurance to cover all risk related to the trial. The study protocol has been approved by the French drug regulatory agency (ANSM) and the French ethical committee (CPP Ouest V). Every investigator approved in writing to conduct patients’ treatment and monitoring in accordance with the protocol. Patient under protection within the meaning of the French legislation were not eligible to the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 4 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 47
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    21
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient signed consent on 10/19/2007 and was included on 10/2007. The last patient was included on 6/26/2014.

    Pre-assignment
    Screening details
    		 During a standard consultation, the medical oncologist presents the study to the patient with liver or lung metatases of colorectal cancer. He gives the patient the consent form to participate in the study. Patients will be able to sign ICF after a reflection period if they deem it necessary or on the day the information is given. Once the cons

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

    Arms
    Arm title
    		 Irinotecan + SBRT
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAMPTO
    Investigational medicinal product code
    Other name
    Irinotecan
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Two weekly 40mg/m2 intravenous infusions

    Number of subjects in period 1
    		Irinotecan + SBRT
    Started
    47
    Completed
    47

    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
    		 47 47
    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)
    		 21 21
        From 65-84 years
    		 26 26
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 69.4 (46 to 84) -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 27 27

    End points

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    End points reporting groups
    Reporting group title
    Irinotecan + SBRT
    Reporting group description
    		 -

    Primary: Primary efficacy endpoint

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    End point title
    		 Primary efficacy endpoint [1]
    End point description
    End point type
    Primary
    End point timeframe
    one year
    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: Single arm - No stastistical analyse was performed
    End point values
    		 Irinotecan + SBRT
    Number of subjects analysed
    47
    Units: percent
        number (confidence interval 84.2%)
    84.2 (69.7 to 92.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From consent until 30 days after the end of traitment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC-AE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 44 (15.91%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Budd-Chiari syndrome
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sepsis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 44 (88.64%)
    General disorders and administration site conditions
    anorexia
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Asthenia
         subjects affected / exposed
    13 / 44 (29.55%)
         occurrences all number
    16
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    17 / 44 (38.64%)
         occurrences all number
    20
    Vomiting
         subjects affected / exposed
    8 / 44 (18.18%)
         occurrences all number
    9
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2009
    Update the list of investigators
    29 Sep 2009
    - Modification of the no inclusion criteria - Evaluation of the response to M6 and not to M3 - Extension of inclusion until 28/01/2014
    20 Dec 2011
    - Increased radiation therapy dose from 40 to 48 Gy - Extension of inclusion until December 2014
    19 Jun 2012
    - Update the list of investigator(s) - Update of the sponsor’s contact details
    16 Jul 2013
    - Update the list of investigator(s)
    21 Jan 2014
    - Extension of inclusion until 19/06/2014 - Increase the number of patient to include - Update the list of investigator(s)

    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
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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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