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    Clinical Trial Results:
    A randomised trial to determine the impact of timing of surgery and chemotherapy in newly diagnosed patients with advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma

    Summary
    EudraCT number
    2007-004429-45
    Trial protocol
    GB  
    Global end of trial date
    16 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jul 2016
    First version publication date
    09 Jul 2016
    Other versions
    Summary report(s)
    Chorus Lancet paper
    Chorus Lancet paper - Supplementary Appendix

    Trial information

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    Trial identification
    Sponsor protocol code
    CHORUS
    Additional study identifiers
    ISRCTN number
    ISRCTN74802813
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MRC Clinical Trials Unit at UCL
    Sponsor organisation address
    Aviation House, 125 Kingsway, London, United Kingdom, WC2B 6NH
    Public contact
    General enquiries office, MRC Clinical Trials Unit at UCL, 0044 020 7670 4700, enquiries@ctu.mrc.ac.uk
    Scientific contact
    General enquiries office, MRC Clinical Trials Unit at UCL, 0044 020 7670 4700, enquiries@ctu.mrc.ac.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
    31 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of neoadjuvant chemotherapy i.e. chemotherapy given before and after primary surgery compared to standard surgery followed by chemotherapy
    Protection of trial subjects
    National ethical and regulatory approvals were obtained in the UK and New Zealand, with local approvals obtained at each centre. The IDMC and independent Trial Steering Committees oversaw the running of the trial. All participating centres were public hospitals that regularly undertook treatment of ovarian cancer with multidisciplinary teams that included specialist surgeons, oncologists, and pathologists.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Mar 2004
    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: 537
    Country: Number of subjects enrolled
    New Zealand: 13
    Worldwide total number of subjects
    550
    EEA total number of subjects
    537
    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)
    260
    From 65 to 84 years
    284
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment ran from 5th March 2004 to 26th August 2010.

    Pre-assignment
    Screening details
    At screening, all women had a clinical assessment, an imaging test (a CT or MRI scan of the abdomen and pelvis, and a radiograph of the chest), and concentrations of serum tumour markers measured (CA125 and CEA).

    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
    Primary surgery
    Arm description
    Primary surgery followed by six cycles of chemotherapy.
    Arm type
    Active comparator

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The recommended treatment doses as defined in the protocol are: • Single-agent Carboplatin either o Target AUC5 x (51Cr-EDTA clearance + 25)mg or o Target AUC6 x (calculated GFR or 24-hour urinary clearance + 25)mg • Carboplatin in combination with Paclitaxel o Paclitaxel 175mg/m2 o Carboplatin either -Target AUC5 x (51Cr-EDTA clearance + 25)mg or -Target AUC6 x (calculated GFR or 24-hour urinary clearance + 25)

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The recommended treatment doses as defined in the protocol are: Carboplatin in combination with Paclitaxel o Paclitaxel 175mg/m2 o Carboplatin either -Target AUC5 x (51Cr-EDTA clearance + 25)mg or -Target AUC6 x (calculated GFR or 24-hour urinary clearance + 25)

    Arm title
    Primary chemotherapy
    Arm description
    Three cycles of primary chemotherapy, then surgery, followed by three more cycles of completion chemotherapy.
    Arm type
    Experimental

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The recommended treatment doses as defined in the protocol are: • Single-agent Carboplatin either o Target AUC5 x (51Cr-EDTA clearance + 25)mg or o Target AUC6 x (calculated GFR or 24-hour urinary clearance + 25)mg • Carboplatin in combination with Paclitaxel o Paclitaxel 175mg/m2 o Carboplatin either -Target AUC5 x (51Cr-EDTA clearance + 25)mg or -Target AUC6 x (calculated GFR or 24-hour urinary clearance + 25)

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The recommended treatment doses as defined in the protocol are: Carboplatin in combination with Paclitaxel o Paclitaxel 175mg/m2 o Carboplatin either -Target AUC5 x (51Cr-EDTA clearance + 25)mg or -Target AUC6 x (calculated GFR or 24-hour urinary clearance + 25)

    Number of subjects in period 1
    Primary surgery Primary chemotherapy
    Started
    276
    274
    Completed
    276
    274

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Primary surgery
    Reporting group description
    Primary surgery followed by six cycles of chemotherapy.

    Reporting group title
    Primary chemotherapy
    Reporting group description
    Three cycles of primary chemotherapy, then surgery, followed by three more cycles of completion chemotherapy.

    Reporting group values
    Primary surgery Primary chemotherapy Total
    Number of subjects
    276 274 550
    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)
    128 132 260
        From 65-84 years
    145 139 284
        85 years and over
    3 3 6
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    66 (57 to 72) 65 (59 to 71) -
    Gender categorical
    Units: Subjects
        Female
    276 274 550
        Male
    0 0 0
    FIGO stage
    Clinical FIGO stage
    Units: Subjects
        FIGO stage III
    206 206 412
        FIGO stage IV
    70 68 138

    End points

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    End points reporting groups
    Reporting group title
    Primary surgery
    Reporting group description
    Primary surgery followed by six cycles of chemotherapy.

    Reporting group title
    Primary chemotherapy
    Reporting group description
    Three cycles of primary chemotherapy, then surgery, followed by three more cycles of completion chemotherapy.

    Primary: Overall survival

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    End point title
    Overall survival
    End point description
    End point type
    Primary
    End point timeframe
    OS at data cut-off of 31st May 2014.
    End point values
    Primary surgery Primary chemotherapy
    Number of subjects analysed
    276
    274
    Units: Months
        median (confidence interval 95%)
    22.6 (18.6 to 25.9)
    21.4 (21 to 28.7)
    Statistical analysis title
    Overall survival
    Statistical analysis description
    Hazard ratio to assess non-inferiority. Upper limit of 90% CI needs to exclude 1.18 to meet pre-specified criteria for non-inferiority.
    Comparison groups
    Primary surgery v Primary chemotherapy
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    90%
         sides
    1-sided
         lower limit
    -
         upper limit
    0.98

    Secondary: Progression Free Survival

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    End point title
    Progression Free Survival
    End point description
    PFS measured from date of randomisation to date of death or confirmed progression. Patients without a date of death are censored at the date they were last known to be alive and progression free.
    End point type
    Secondary
    End point timeframe
    PFS up to data cut-off point of 31st May 2014.
    End point values
    Primary surgery Primary chemotherapy
    Number of subjects analysed
    276
    274
    Units: Months
        median (confidence interval 95%)
    10.7 (9.7 to 11.9)
    12 (10.6 to 13.1)
    Statistical analysis title
    PFS
    Statistical analysis description
    Hazard ratio of PFS.
    Comparison groups
    Primary surgery v Primary chemotherapy
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    1.09

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse event reporting was scheduled throughout follow-up, but summaries are focussed on the treatment period due to the scarcity of reporting after that point.
    Adverse event reporting additional description
    Specific SAE's are listed if >1% of patients in either arm were affected. All other SAE's are grouped under "Other". Non-serious adverse events were not routinely reported, other than through chemotherapy toxicity reports, and are not included here.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Primary surgery
    Reporting group description
    Primary surgery followed by six cycles of chemotherapy.

    Reporting group title
    Primary chemotherapy
    Reporting group description
    Three cycles of primary chemotherapy, then surgery, followed by three more cycles of completion chemotherapy.

    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: Non-serious adverse events were not routinely collected, other than reporting through chemotherapy toxicities, and are not included here.
    Serious adverse events
    Primary surgery Primary chemotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    67 / 251 (26.69%)
    75 / 253 (29.64%)
         number of deaths (all causes)
    231
    220
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 251 (1.20%)
    4 / 253 (1.58%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    4 / 251 (1.59%)
    4 / 253 (1.58%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    5 / 251 (1.99%)
    5 / 253 (1.98%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shortness of breath
         subjects affected / exposed
    7 / 251 (2.79%)
    5 / 253 (1.98%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Other events
         subjects affected / exposed
    44 / 251 (17.53%)
    45 / 253 (17.79%)
         occurrences causally related to treatment / all
    11 / 64
    11 / 74
         deaths causally related to treatment / all
    1 / 10
    0 / 5
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    16 / 251 (6.37%)
    22 / 253 (8.70%)
         occurrences causally related to treatment / all
    4 / 19
    5 / 26
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Abdominal pain
         subjects affected / exposed
    10 / 251 (3.98%)
    9 / 253 (3.56%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    7 / 251 (2.79%)
    7 / 253 (2.77%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowel obstruction
         subjects affected / exposed
    3 / 251 (1.20%)
    7 / 253 (2.77%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Constipation
         subjects affected / exposed
    6 / 251 (2.39%)
    9 / 253 (3.56%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    8 / 251 (3.19%)
    6 / 253 (2.37%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    4 / 251 (1.59%)
    6 / 253 (2.37%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    5 / 251 (1.99%)
    8 / 253 (3.16%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Primary surgery Primary chemotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)

    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/26002111
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