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    Clinical Trial Results:
    A multi-centre phase II study using Carboplatin AUC-10 for metastatic seminoma with IGCCCG good prognosis disease - therapy directed by initial metabolic response on PET-CT [CAR-PET]

    Summary
    EudraCT number
    2009-009882-33
    Trial protocol
    GB  
    Global end of trial date
    13 Oct 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Sep 2018
    First version publication date
    06 Sep 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TE-2009-01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02272816
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Barts Health NHS Trust
    Sponsor organisation address
    Joint Research Management Office (JRMO), 5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    Dr Jonathan Shamash, Centre for Experimental Cancer Medicine, QMUL, bci-carpet@qmul.ac.uk
    Scientific contact
    Dr Jonathan Shamash, Barts Health NHS Trust, Jonathan.Shamash@bartshealth.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
    13 Oct 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety, efficacy and toxicity of carboplatin AUC-10 in metastatic seminoma in a multi centre setting.
    Protection of trial subjects
    Participant safety was continuously monitored through reporting of adverse events and laboratory assessments. Requirements for platelets, white blood cells and neutrophil levels for treatment to proceed were specified in the protocol with guidance on management in the event that these parameters were below the required levels. A Trial Steering Committee (TSC) convened periodically throughout the trial to review the conduct of the clinical trial to ensure continuing patient safety.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    47
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients with metastatic chemotherapy and radiotherapy naïve seminoma who had International Germ Cell Cancer Collaborative Group (IGCCCG) good prognosis disease (i.e. no non-pulmonary visceral metastases) were recruited into the study at two centres in London, United Kingdom between Feb - 2012 and Apr - 2015.

    Pre-assignment
    Screening details
    48 patients were screened for the study and all were found to be eligible and were recruited into the study.

    Pre-assignment period milestones
    Number of subjects started
    48
    Number of subjects completed
    48

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

    Arms
    Arm title
    Carboplatin AUC-10
    Arm description
    Carboplatin AUC-10 according to the Calvert formula (10 x (GFR (ml/min) + 25) mg
    Arm type
    Experimental

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin AUC 10 according to the Calvert formula (10 x (GFR (ml/min) + 25) mg was given in 5% glucose over 1 hour every 21 days. A PET-CT scan was carried out on day 17-21 of the first cycle. The PET - CT scans were centrally reviewed. If the PET - CT scan showed a complete response (Deauville ≤3) the patient would stop treatment after 3 cycles. If the PET – CT showed persistent activity (Deauville >3), then patients went on to have 4 cycles in total

    Number of subjects in period 1
    Carboplatin AUC-10
    Started
    48
    Completed
    48

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    On study
    Reporting group description
    -

    Reporting group values
    On study Total
    Number of subjects
    48 48
    Age categorical
    Age at time of enrolment.
    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)
    47 47
        From 65-84 years
    1 1
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    48 48
    Primary tumour
    Units: Subjects
        Testis
    46 46
        Mediastinum
    1 1
        Retroperitoneum
    1 1
    Sites of metastases
    Units: Subjects
        Lung
    2 2
        Lymph nodes
    29 29
        Other
    9 9
        Not recorded
    8 8
    ECOG PS
    Eastern Cooperative Oncology Group Performance Status. 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. 3 - Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours.
    Units: Subjects
        ECOG PS = 0
    41 41
        ECOG PS = 1
    2 2
        ECOG PS = 2
    0 0
        ECOG PS = 3
    0 0
        Not recorded
    5 5
    Stage of disease
    Units: Subjects
        2A
    13 13
        2B
    23 23
        2C
    11 11
        N/A (Mediastinal)
    1 1
    Tumour marker: Alpha-fetoprotein
    Units: Subjects
        Normal
    48 48
        Elevated
    0 0
    Tumour marker: Beta-Human Chorionic Gonadotropin
    Units: Subjects
        Normal
    36 36
        Elevated
    12 12
    Tumour marker: Lactate dehydrogenase
    Units: Subjects
        Normal
    34 34
        Elevated (< 3xULN)
    11 11
        Elevated (≥ 3xULN)
    2 2
        Not recorded
    1 1
    Glomerular Filtration Rate
    EDTA clearance (43 subjects) or estimated creatinine clearance determined by Cockcroft-Gault equation (5 subjects).
    Units: Subjects
        25 - 120 ml/min
    35 35
        > 120 ml/min
    13 13

    End points

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    End points reporting groups
    Reporting group title
    Carboplatin AUC-10
    Reporting group description
    Carboplatin AUC-10 according to the Calvert formula (10 x (GFR (ml/min) + 25) mg

    Primary: Progression Free Survival

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    End point title
    Progression Free Survival [1]
    End point description
    Number of subjects progression free at 2 years from registration.
    End point type
    Primary
    End point timeframe
    2 years from registration.
    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: It is not possible to enter statistical analysis as at least 2 comparison groups are required for this.
    End point values
    Carboplatin AUC-10
    Number of subjects analysed
    48
    Units: Subjects
        Progression free
    46
        Progressed
    2
    No statistical analyses for this end point

    Secondary: Metabolic Response Rate

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    End point title
    Metabolic Response Rate
    End point description
    Number of subjects achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after 1 cycle of treatment.
    End point type
    Secondary
    End point timeframe
    21 days
    End point values
    Carboplatin AUC-10
    Number of subjects analysed
    47
    Units: Subjects
        CR
    21
        PR
    26
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    Overall Survival
    End point description
    Number of subjects alive at 2 years from registration.
    End point type
    Secondary
    End point timeframe
    2 years from registration.
    End point values
    Carboplatin AUC-10
    Number of subjects analysed
    48
    Units: Subjects
        Alive
    48
        Deceased
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Start of treatment until 30 days after last dose.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Carboplatin AUC-10
    Reporting group description
    Carboplatin AUC-10 according to the Calvert formula (10 x (GFR (ml/min) + 25) mg

    Serious adverse events
    Carboplatin AUC-10
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 48 (25.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    4 / 48 (8.33%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Hearing impaired
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 48 (6.25%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Calculus bladder
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Carboplatin AUC-10
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 48 (97.92%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    44 / 48 (91.67%)
         occurrences all number
    111
    Pain
         subjects affected / exposed
    6 / 48 (12.50%)
         occurrences all number
    7
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    3 / 48 (6.25%)
         occurrences all number
    4
    Mood swings
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Sunburn
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    34 / 48 (70.83%)
         occurrences all number
    81
    Platelet count decreased
         subjects affected / exposed
    28 / 48 (58.33%)
         occurrences all number
    53
    Weight decreased
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Weight increased
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    27 / 48 (56.25%)
         occurrences all number
    49
    Febrile neutropenia
         subjects affected / exposed
    2 / 48 (4.17%)
         occurrences all number
    2
    Pancytopenia
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    4 / 48 (8.33%)
         occurrences all number
    4
    Hiccups
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 48 (4.17%)
         occurrences all number
    2
    Neuropathy peripheral
         subjects affected / exposed
    6 / 48 (12.50%)
         occurrences all number
    7
    Ear and labyrinth disorders
    Hearing impaired
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Tinnitus
         subjects affected / exposed
    13 / 48 (27.08%)
         occurrences all number
    15
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    17 / 48 (35.42%)
         occurrences all number
    26
    Diarrhoea
         subjects affected / exposed
    7 / 48 (14.58%)
         occurrences all number
    11
    Gastritis
         subjects affected / exposed
    2 / 48 (4.17%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    37 / 48 (77.08%)
         occurrences all number
    70
    Stomatitis
         subjects affected / exposed
    16 / 48 (33.33%)
         occurrences all number
    24
    Vomiting
         subjects affected / exposed
    14 / 48 (29.17%)
         occurrences all number
    19
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    8 / 48 (16.67%)
         occurrences all number
    9
    Rash
         subjects affected / exposed
    3 / 48 (6.25%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    22 / 48 (45.83%)
         occurrences all number
    38
    Infections and infestations
    Infection
         subjects affected / exposed
    4 / 48 (8.33%)
         occurrences all number
    5
    Neutropenic sepsis
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Apr 2012
    - Inclusion criterion 2 amended to specify minimum required glomerular filtration rate of 25ml/min (value was missing). - Inclusion criterion 5 amended to clarify that age range is inclusive of 18 and 75 years. - Full Blood Count added on Cycle 1 Day 13-17 to check blood counts prior to proceeding to cycle 4 (previous version specified only cycle 2-4). - CT scan within 28 days of completing treatment removed as not required.
    29 May 2012
    Change in Sponsor name from Barts and the London NHS Trust to Barts Health NHS Trust.
    19 Dec 2012
    - Removal of requirement for post - treatment PET - CT scan for patients who have complete remission after cycle 1. - Allowable window included for Day 1 procedures on Cycles 2 – 4. - Confirmation that dose banding is not permitted added.
    24 Oct 2013
    - Change in requirements for recording concomitant medications. The IMP for this study was a licensed product, therefore it was not deemed necessary to record concomitant medications administered as supportive care. - Clarification added for when to recalculate Carboplatin dose. The glomerular filtration rate determined by EDTA clearance was only assessed pretreatment. Therefore the dose only needed to be recalculated if serum Creatinine rose >20% above baseline.
    12 Feb 2015
    - Clarification of the process for sending images for central review. - Amendments to the reporting timelines for the central review. - Change in Sponsor's representative. - Addition of urgent safety measure procedures. - Update to the pregnancy reporting procedures.
    21 Sep 2015
    - Exemption of requirement for baseline CT scan if PET-CT scan was done instead if clinician already suspected diagnosis to avoid unnecessary scans for trial subjects.
    10 Oct 2017
    - Reduction of the follow-up period from three years to two years. This decision was made as normally less than 10% of the total recurrences occur beyond 2 years and hence it has now become convention to quote 2 year progression-free survival in germ cell tumour (GCT) studies. This change does not affect the scope or validity of trial results, and was made after review by the Chief Investigator and trial statistician. - The end of the study definition was changed from “the date the last patient has completed his final follow up visit” to “3 months after the date when the last patient has completed his final follow up visit”. This was to allow additional time for data collection, cleaning, and analysis.

    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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