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    Clinical Trial Results:
    Induction chemotherapy with Carboplatin and Navelbine Oral® followed by concomitant Navelbine Oral® and irradiation in local-regionally advanced non-small cell lung cancer. A randomized phase II study.

    Summary
    EudraCT number
    		 2008-008920-34
    Trial protocol
    		 DK  
    Global end of trial date
    21 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2020
    First version publication date
    27 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    09.01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00887783
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J. B. Winsløwsvej 2, Indgang 140, kælderen, Odense, Denmark, 5000
    Public contact
    Olfred Hansen, Odense University Hospital, 0045 24241588, olfred.hansen@rsyd.dk
    Scientific contact
    Olfred Hansen, Odense University Hospital, 0045 24241588, olfred.hansen@rsyd.dk
    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 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial is to test a convenient chemotherapy schedule with an oral formulation of radio-sensitizing Navelbine in concurrent chemo-radiotherapy in radical treatment of inoperable locally advanced non small cell lung cancer (stage IIB-IIIB) with radiotherapy. The trial is a randomized phase II study with two doses of radiotherapy. The primary objective of the study is examine the combination of Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) or 66 Gy (2 Gy x 33, 5 F á week) starting 3 weeks after two cycles of inductions chemotherapy with Navelbine oral and Carboplatin. Primary endpoint: - Local failure free survival at 9 months after start of radiotherapy
    Protection of trial subjects
    Strict planning of radiotherapy observing clear constraints on normal tissue. Frequent clinical follow-up within the trial observing any side adverse effects and risk of relapse.
    Background therapy
    		 .
    Evidence for comparator
    		 .
    Actual start date of recruitment
    01 May 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 117
    Worldwide total number of subjects
    117
    EEA total number of subjects
    117
    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)
    55
    From 65 to 84 years
    62
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The inclusion criteria were histologically or cytologically confirmed NSCLC, clinical American Joint Committee of Cancer stage (the seventh edition) IIB–IIIB, performance status (PS) <2 on the ECOG scale, weight

    Pre-assignment
    Screening details
    		 Patients refered to the participating centers was screened for the study.

    Period 1
    Period 1 title
    Induction
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 Induction chemotherapy
    Arm description
    		 All patients were treated with two cycles of carboplatin day 1 and navelbine day 1 and day 8
    Arm type
    		 Standard

    Investigational medicinal product name
    Navelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Navelbine 60 mg m2 - possible to increase dose to 80 mg m2

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2 cycles of induction therapy - 3 weeks cycles

    Number of subjects in period 1
    		Induction chemotherapy
    Started
    117
    Interim analyses
    117
    Completed
    117
    Period 2
    Period 2 title
    Randomized
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 60 GY
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Navelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Radiotherapy 60 GY, concommittant vinorelbin 50mg Sunday, Tuesday and Thursday

    Arm title
    		 66GY
    Arm description
    		 Radiotherapy 60 GY, concommittant vinorelbin 50mg Sunday, Tuesday and Thursday
    Arm type
    		 Experimental

    Investigational medicinal product name
    Navelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg Sunday, Tuesday and Thursday during RT

    Number of subjects in period 2
    		60 GY 66GY
    Started
    59
    58
    Completed
    59
    58

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Induction
    Reporting group description
    		 -

    Reporting group values
    		 Induction Total
    Number of subjects
    		 117 117
    Age categorical
    Overall study population
    Units: Subjects
        Overall study population
    		 117 117
    Age continuous
    Age distribution
    Units: years
        median (full range (min-max))
    		 65.5 (44 to 82) -
    Gender categorical
    Gender distribution
    Units: Subjects
        Female
    		 49 49
        Male
    		 68 68

    End points

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    End points reporting groups
    Reporting group title
    Induction chemotherapy
    Reporting group description
    		 All patients were treated with two cycles of carboplatin day 1 and navelbine day 1 and day 8
    Reporting group title
    60 GY
    Reporting group description
    		 -

    Reporting group title
    66GY
    Reporting group description
    		 Radiotherapy 60 GY, concommittant vinorelbin 50mg Sunday, Tuesday and Thursday

    Primary: Local progression free interval after start of RT.

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    End point title
    		 Local progression free interval after start of RT. [1]
    End point description
    Local progression free interval 9 month after start of RT measured on PET CT
    End point type
    Primary
    End point timeframe
    Local progression free interval 9 month after start of RT.
    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: Analysis in doi.org/10.1016
    End point values
    Number of subjects analysed
    Units: PETCT
    median (full range (min-max))
        Local tumor control
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From randomization until EOT
    Adverse event reporting additional description
    An AE was defined as any adverse medical event in a patient or subject taking a medical treatment regardless of the causal relationship to the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTC-AE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    66GY
    Reporting group description
    		 Study arm

    Reporting group title
    60GY
    Reporting group description
    		 Study arm

    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: Analysis in doi.org/10.1016
    Serious adverse events
    		 66GY 60GY
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 58 (8.62%)
    3 / 59 (5.08%)
         number of deaths (all causes)
    47
    50
         number of deaths resulting from adverse events
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Esophagitis and pneumonitis
    Additional description: CTCAE grade 4-5
         subjects affected / exposed
    5 / 58 (8.62%)
    3 / 59 (5.08%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 66GY 60GY
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 59 (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.
    The study was a chemo-radiation study including cancerpatients with an expected 3 years survival 20%.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28410809
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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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