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    Clinical Trial Results:
    COUGAR-02: A randomised phase III study of docetaxel vs active symptom control in patients with relapsed oesophago-gastric adenocarcinoma

    Summary
    EudraCT number
    		 2006-005046-37
    Trial protocol
    		 GB  
    Global end of trial date
    28 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    COUGAR-02
    Additional study identifiers
    ISRCTN number
    		 ISRCTN13366390
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cambridge University Hospitals NHS Foundation Trust
    Sponsor organisation address
    Hills Road, Cambridge University Hospitals NHS Foundation Trus, United Kingdom, CB2 0QQ
    Public contact
    Prasanna Kapilan , Cambridge clinical trials unit (CCTU), +44 1223 596 474 , Prasanna.kapilan@addenbrookes.nhs.uk
    Scientific contact
    Hugo Ford , Cambridge University Hospitals NHS Foundation Trust, hugo.ford@addenbrookes.nhs.uk
    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 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether chemotherapy with docetaxel improves survival in patients with advanced gastric cancer previously treated with platinum/fluoropyrimidine or raltitrexed therapy.
    Protection of trial subjects
    The study was approved by a Research Ethics Committee and received authorisation from the Medicines and Healthcare Products Regulatory Authority. Patients received verbal and written information prior to consenting to the trial and had the time to consider their participation and opportunity to ask questions. Patient data and samples were anonymised so that their information was kept confidential.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    01 Apr 2008
    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
    United Kingdom: 168
    Worldwide total number of subjects
    168
    EEA total number of subjects
    168
    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)
    82
    From 65 to 84 years
    86
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between April 2008 to April 2012 a total of 168 patients were randomised from 30 sites across the UK.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 356 [1]
    Number of subjects completed
    		 168

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 71
    Reason: Number of subjects
    		 Not meeting inclusion criteria: 77
    Reason: Number of subjects
    		 Other reasons: 40
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 356 patients screened and 168 patients enrolled to receive protocol treatment.
    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Docetaxel + active symptom control
    Arm description
    		 Docetaxel 75mg/m2 IV every 3 weeks for up to 6 cycles + active symptom control
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    N/A
    Other name
    TAXOTERE
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    "Docetaxel was administered as an intravenous infusion over 1 hour at a dose of 75mg/m2 in 250ml sodium chloride 0.9% solution or 5 % glucose solution every 3 weeks for a maximum of 6 cycles."

    Arm title
    		 active symptom control
    Arm description
    		 active symptom control - may include radiotherapy, analgesia, anti-emetics, steroids.
    Arm type
    		 Active symptom control

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Docetaxel + active symptom control active symptom control
    Started
    84
    84
    Received Allocated Intervention
    77
    78
    Did not receive Allocated Intervention
    7 [2]
    6 [3]
    Completed
    19
    30
    Not completed
    65
    54
         Unacceptable Toxicity / Died
    27
    32
         died
    3
    -
         Consent withdrawn by subject
    2
    5
         entered phase I
    -
    7
         progressive disease
    -
    1
         patient decision (wanted CT)
    -
    4
         delay >21 days
    5
    -
         Lost to follow-up
    -
    2
         Poor Performance Status / Declined Further Assessm
    1
    2
         patient admitted
    1
    -
         Lack of efficacy
    26
    1
    Notes
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 356 patients screened and 168 patients enrolled to receive protocol treatment.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 356 patients screened and 168 patients enrolled to receive protocol treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Docetaxel + active symptom control
    Reporting group description
    		 Docetaxel 75mg/m2 IV every 3 weeks for up to 6 cycles + active symptom control

    Reporting group title
    active symptom control
    Reporting group description
    		 active symptom control - may include radiotherapy, analgesia, anti-emetics, steroids.

    Reporting group values
    		 Docetaxel + active symptom control active symptom control Total
    Number of subjects
    		 84 84 168
    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)
    		 41 41 82
        From 65-84 years
    		 43 43 86
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 65 (28 to 84) 66 (36 to 84) -
    Gender categorical
    Docetaxel 75mg/m2 IV every 3 weeks for up to 6 cycles + active symptom control
    Units: Subjects
        Female
    		 15 17 32
        Male
    		 69 67 136
    ECOG PS
    ECOG Performance Status
    Units: Subjects
        T0
    		 24 22 46
        T1
    		 46 50 96
        T2
    		 14 12 26
    Disease status
    Disease status
    Units: Subjects
        Local advanced
    		 11 10 21
        metastatic disease
    		 73 74 147
    Site of primary disease
    Site of primary disease
    Units: Subjects
        Oesophagus
    		 18 15 33
        OG junction
    		 27 32 59
        Stomach
    		 39 37 76
    Time between end of previous chemotherapy and documented disease progression
    Time between end of previous chemotherapy and documented disease progression
    Units: Subjects
        During treatment
    		 36 36 72
        Within 3 months from end of treatment
    		 27 22 49
        Within 3-6 months from end of treatment
    		 21 26 47
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised 168 patients are included in the analysis

    Subject analysis sets values
    		 ITT
    Number of subjects
    168
    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)
    82
        From 65-84 years
    86
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Docetaxel 75mg/m2 IV every 3 weeks for up to 6 cycles + active symptom control
    Units: Subjects
        Female
    32
        Male
    136
    ECOG PS
    ECOG Performance Status
    Units: Subjects
        T0
    46
        T1
    96
        T2
    26
    Disease status
    Disease status
    Units: Subjects
        Local advanced
    21
        metastatic disease
    147
    Site of primary disease
    Site of primary disease
    Units: Subjects
        Oesophagus
    33
        OG junction
    59
        Stomach
    76
    Time between end of previous chemotherapy and documented disease progression
    Time between end of previous chemotherapy and documented disease progression
    Units: Subjects
        During treatment
    72
        Within 3 months from end of treatment
    49
        Within 3-6 months from end of treatment
    47

    End points

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    End points reporting groups
    Reporting group title
    Docetaxel + active symptom control
    Reporting group description
    		 Docetaxel 75mg/m2 IV every 3 weeks for up to 6 cycles + active symptom control

    Reporting group title
    active symptom control
    Reporting group description
    		 active symptom control - may include radiotherapy, analgesia, anti-emetics, steroids.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised 168 patients are included in the analysis

    Primary: Primary

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    End point title
    		 Primary
    End point description
    End point type
    Primary
    End point timeframe
    Patients were assessed every 3 weeks for first 18 weeks and every 6 weeks thereafter for up to 1 year. After 1 year, patients were reviewed every 3 months until death.
    End point values
    		 Docetaxel + active symptom control active symptom control ITT
    Number of subjects analysed
    84
    84
    0 [1]
    Units: Months
    median (confidence interval 95%)
        Overall survival
    5.2 (4.1 to 5.9)
    3.6 (3.3 to 4.4)
    ( to )
    Notes
    [1] - this is not applicable for combining both groups.
    Statistical analysis title
    		 Overall survival
    Statistical analysis description
    Overall survival
    Comparison groups
    Docetaxel + active symptom control v active symptom control
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 0.92

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    For patients on the Docetaxel + Active symptom control arm of the study (Arm A) AEs will be monitored and recorded from randomisation until 21 days after the last administration of study drug. For patients on the Active symptom control arm of the stud
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 National Cancer Inst
    Dictionary version
    3
    Reporting groups
    Reporting group title
    active symptom control
    Reporting group description
    		 active symptom control - may include radiotherapy, analgesia, anti-emetics, steroids.

    Serious adverse events
    		 active symptom control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 84 (0.00%)
         number of deaths (all causes)
    81
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 active symptom control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 84 (0.00%)
    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: Adverse events reported are given in the publication attached.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24332238
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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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