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    Clinical Trial Results:
    Etude de phase II évaluant un traitement par cisplatine et vinorelbine orale administrés de façon hebdomadaire et radiothérapie concomitante chez le sujet âgé indépendant atteint de cancer broncho-pulmonaire non à petites cellules localisé non opérable.

    Summary
    EudraCT number
    		 2009-012413-21
    Trial protocol
    		 FR  
    Global end of trial date
    17 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 May 2021
    First version publication date
    28 May 2021
    Other versions
    Summary report(s)
    		 Suammary results

    Trial information

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    Trial identification
    Sponsor protocol code
    I08011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01029678
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Limoges
    Sponsor organisation address
    2 Avenue Martin Luther King -, Limoges , France, 87042
    Public contact
    Pr Alain VERGNENEGRE Pricipal Investigator, CHU de Limoges, 33 555056149, alain.vergnenegre@chu-limoges.fr
    Scientific contact
    Pr Alain VERGNENEGRE Pricipal Investigator, CHU de Limoges, 33 555056149, alain.vergnenegre@chu-limoges.fr
    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
    06 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assessment of the Safety of a cisplatine/vinorelbine traitment
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed. All patients gave their consent after full information. Moreover, a DSMB ensured the ethical and safety oversight of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jul 2010
    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
    France: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    0
    From 65 to 84 years
    49
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were enrolled in 16 French participating centers between 19/07/2010 and 27/11/2013.

    Pre-assignment
    Screening details
    		 Main inclusion criteria were: age >70 years; histologically proven NSCLC; unresectable stage IIIAN2 or stage IIIB disease without pleural involvement or supraclavicular lymph-node invasion; PS score 0 or 1. Main exclusion criteria were: active malignancy within the past 5 years, bronchoalveolar, neuroendocrine or composite cancer histology.

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

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Oral vinorelbine 30 mg/m2 for 6 weeks.

    Investigational medicinal product name
    cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weekly IV cisplatin (30 mg/m²)

    Number of subjects in period 1
    		Overall trial
    Started
    49
    Completed
    40
    Not completed
    9
         Consent withdrawn by subject
    1
         Protocol deviation
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 49 49
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (standard deviation)
    		 75.1 ± 4 -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 42 42

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Primary: Number of patients with grade >2 clinically relevant adverse events

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    End point title
    		 Number of patients with grade >2 clinically relevant adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    4 week after end of treatment
    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: See attached paper
    End point values
    		 Overall trial
    Number of subjects analysed
    40
    Units: percent of patients
    20
    No statistical analyses for this end point

    Secondary: Objective response rate (ORR)

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    End point title
    		 Objective response rate (ORR)
    End point description
    Number of patients with complete response, partial responses and with stabilized disease.
    End point type
    Secondary
    End point timeframe
    4 weeks after the end of treatment
    End point values
    		 Overall trial
    Number of subjects analysed
    40
    Units: Percentage of patients
    37
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS).

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    End point title
    		 Progression-free survival (PFS).
    End point description
    End point type
    Secondary
    End point timeframe
    2 years following the last inclusion
    End point values
    		 Overall trial
    Number of subjects analysed
    39
    Units: Month
        median (confidence interval 95%)
    15 (8.7 to 35.2)
    Attachments
    		 overall survival and progression-free survival
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    End point type
    Secondary
    End point timeframe
    2 years after the last inclusion
    End point values
    		 Overall trial
    Number of subjects analysed
    39
    Units: month
        median (confidence interval 95%)
    21.8 (16 to 21.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of inclusions until one month after the end of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Overal trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overal trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 48 (20.83%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to liver
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Injury, poisoning and procedural complications
    Radiation fibrosis
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Vascular graft
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Catheter sepsis
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Bronchial disorder
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Musculoskeletal and connective tissue disorders
    Back pain
         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
    Candida sepsis
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         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: 5%
    Non-serious adverse events
    		 Overal trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 48 (68.75%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 48 (16.67%)
         occurrences all number
    17
    Platelet count decreased
         subjects affected / exposed
    8 / 48 (16.67%)
         occurrences all number
    13
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    16 / 48 (33.33%)
         occurrences all number
    28
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    6 / 48 (12.50%)
         occurrences all number
    10
    Dysphagia
         subjects affected / exposed
    5 / 48 (10.42%)
         occurrences all number
    7
    Esophagitis
         subjects affected / exposed
    11 / 48 (22.92%)
         occurrences all number
    11
    Nausea
         subjects affected / exposed
    12 / 48 (25.00%)
         occurrences all number
    20
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 48 (22.92%)
         occurrences all number
    15
    Dyspnea
         subjects affected / exposed
    5 / 48 (10.42%)
         occurrences all number
    10

    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/21277475
    http://www.ncbi.nlm.nih.gov/pubmed/29858022
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