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    Clinical Trial Results:
    A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide with Radiotherapy in Diffuse Pontine Gliomas

    Summary
    EudraCT number
    		 2007-001768-60
    Trial protocol
    		 GB  
    Global end of trial date
    24 Jan 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Dec 2019
    First version publication date
    17 Feb 2019
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    Wrong upload provided
    Summary report(s)
    		 BS TEM ESR 17Feb2014

    Trial information

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    Trial identification
    Sponsor protocol code
    CNS 2007 04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor ID : RG_09-200
    Sponsors
    Sponsor organisation name
    University of Birmingham
    Sponsor organisation address
    Edgbaston , Birmingham , United Kingdom, B15 2TT
    Public contact
    Nicola Fenwick , University of Birmingham , reg@trials.bham.ac.uk
    Scientific contact
    Nicola Fenwick , University of Birmingham , reg@trials.bham.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
    17 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the time to death in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low dose oral Temozolomide and radiation therapy, followed by up to 12 months maintenance therapy with extended low dose Temozolomide. • To assess the quality of life in patients with diffuse pontine gliomas during and after the above treatment.
    Protection of trial subjects
    The study was reviewed and approved by East Midlands Research Ethics Committee (REC) 07/MRE04/38 The patients and/or parents provided written consent to participate in the study after a full explanation was been given of the treatment options. If the patient was a minor, the treatment was explained to, and consent received from, his or her parent or guardian. Additionally the child received an age appropriate explanation and could give assent as well if he/she was able to do so. The right of a patient or parents/guardian to refuse to participate without giving reasons was respected.
    Background therapy
    		 Radiotherapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jan 2008
    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: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    35
    Adolescents (12-17 years)
    6
    Adults (18-64 years)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 43 patients were recruited between 07-Feb-2008 and 07-Jul-2010 from 16 UK centres.

    Pre-assignment
    Screening details
    		 Inclusion Criteria a) Newly diagnosed diffuse intrinsic lesion centred in the pons on MRI imaging. No requirement for histological diagnosis. b) Age between 2 and 21 years c)Karnofsky Performance Status (KPS) or a Lansky play score of 60 d) Adequate neutrophil and platelet count

    Period 1
    Period 1 title
    Registration (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BSG Treatment: Temozolomide with radiotherapy
    Arm description
    		 Temozolomide at a low dose of 75 mg/m2 administered daily for 6 weeks during radiotherapy (7 days per week), starting up to 72 hours prior to the first dose of radiotherapy. Temozolomide administered at 75 mg/m2/day for 6 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Temozolomide be administered at 75 mg/m2/day for 6 weeks. All doses rounded up to the nearest 5mg to accommodate capsule strength, and given with a glass of water after a minimum 2 hour fast. If the child was unable to swallow capsules then the capsules may be opened and diluted in apple juice prior to swallowing.

    Number of subjects in period 1
    		BSG Treatment: Temozolomide with radiotherapy
    Started
    43
    Completed
    43

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BSG Treatment: Temozolomide with radiotherapy
    Reporting group description
    		 Temozolomide at a low dose of 75 mg/m2 administered daily for 6 weeks during radiotherapy (7 days per week), starting up to 72 hours prior to the first dose of radiotherapy. Temozolomide administered at 75 mg/m2/day for 6 weeks

    Reporting group values
    		 BSG Treatment: Temozolomide with radiotherapy Total
    Number of subjects
    		 43 43
    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)
    		 35 35
        Adolescents (12-17 years)
    		 6 6
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    BSG Treatment: Temozolomide with radiotherapy
    Reporting group description
    		 Temozolomide at a low dose of 75 mg/m2 administered daily for 6 weeks during radiotherapy (7 days per week), starting up to 72 hours prior to the first dose of radiotherapy. Temozolomide administered at 75 mg/m2/day for 6 weeks

    Subject analysis set title
    Treatment Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients entered in to the study.

    Primary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Median survival times to tumour progression and to death after study entry. The response rate will be summarised and compared to historical controls treated with standard radiotherapy alone.
    End point type
    Primary
    End point timeframe
    Until death
    End point values
    		 BSG Treatment: Temozolomide with radiotherapy Treatment Analysis Set
    Number of subjects analysed
    43
    43
    Units: patient
        number (not applicable)
    43
    43
    Statistical analysis title
    		 Overall survival
    Comparison groups
    BSG Treatment: Temozolomide with radiotherapy v Treatment Analysis Set
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.23
    Method
    		 likelihood Bayesian
    Confidence interval
    Notes
    [1] - Study design: This trial was originally designed as a Case-Morgan design. This method was chosen to allow the trial to stop early for futility. It was a single arm study, testing a null hypothesis of 50% overall survival at 9 months against an alternate hypothesis of 70%. The level of significance for the study was set at a 1-tailed alpha of 0.05. There was one intermediate analysis for futility, which did not result in the trial stopping. The primary hypothesis test in the study was a 1-ta

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Patients were observed for safety for 30 days following the last dose of temozolomide
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTACE
    Dictionary version
    4
    Frequency threshold for reporting non-serious adverse events: 0%
    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: 43 patients were registered in to the study - for all of which non-serious adverse events were recorded. See attached publication and end of study report for further information. 19 Serious Adverse Reactions were recorded for 17 patients. See attached publication and end of study report for further information.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Mar 2008
    Treatment updated from 12 months to 12 cycles. Duration of follow-up amended. QOL elements updated. Change in timing of start of radiotherapy.
    01 May 2010
    Contact details updated to the Cancer Research UK Clinical Trials Unit. Change to SAE reporting contact details.

    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/24011536
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