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    Clinical Trial Results:
    COMPARISON OF 2 CHEMOTHERAPY REGIMENS IN NON SMALL CELL LUNG CANCER PATIENTS RELAPSING AFTER SURGERY AND PERI OPERATIVE CHEMOTHERAPY A RANDOMIZED PHASE III STUDY.

    Summary
    EudraCT number
    		 2007-001997-97
    Trial protocol
    		 FR  
    Global end of trial date
    30 Nov 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Nov 2016
    First version publication date
    23 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IFCT-0702
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00535275
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IFCT
    Sponsor organisation address
    10 rue de la Grange-Batelière, PARIS, France,
    Public contact
    Sponsor, IFCT, contact@ifct.fr
    Scientific contact
    Sponsor, IFCT, contact@ifct.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
    31 Jan 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Determine the best chemotherapy option in progressive disease patients initially treated with perioperative chemotherapy and surgery Progression free survival will be the end point of this 2 arms study: • docetaxel alone • docetaxel cisplatin
    Protection of trial subjects
    Reductions of dose of the treatment
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Nov 2007
    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
    France: 88
    Worldwide total number of subjects
    88
    EEA total number of subjects
    88
    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)
    60
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period : 22/11/2007 to 02/08/2012. Territory : France

    Pre-assignment
    Screening details
    		 Patients previously treated with surgery and peri operative chemotherapy for a Non small cell lung cancer (at least 2 full cycles of a platinum containing regimen)

    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
    		 Arm B : Monotherapy
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    docetaxel: 75 mg/ m2 D1, every 3 weeks (D1 – D22) in a 60 minutes infusion.

    Arm title
    		 Arm A : Bitherapy
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    docetaxel: 75 mg/ m2 D1, every 3 weeks (D1 – D22) in a 60 minutes infusion.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    cisplatin* 75 mg/m2 at D1 - Cycles of 21 days

    Number of subjects in period 1
    		Arm B : Monotherapy Arm A : Bitherapy
    Started
    44
    44
    Completed
    27
    22
    Not completed
    17
    22
         Adverse event, serious fatal
    1
    2
         Patient refusal
    -
    1
         Adverse event, non-fatal
    3
    9
         Unspecified
    -
    3
         Lack of efficacy
    13
    7

    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
    		 88 88
    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)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 60 60
        From 65-84 years
    		 28 28
        85 years and over
    		 0 0
        Adults
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 61.79 (41.62 to 75.61) -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 68 68

    End points

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    End points reporting groups
    Reporting group title
    Arm B : Monotherapy
    Reporting group description
    		 -

    Reporting group title
    Arm A : Bitherapy
    Reporting group description
    		 -

    Primary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    End point type
    Primary
    End point timeframe
    Time between the date of randomisation and the date of progression
    End point values
    		 Arm B : Monotherapy Arm A : Bitherapy
    Number of subjects analysed
    44
    44
    Units: Months
        median (confidence interval 95%)
    5.6 (4 to 7.3)
    8 (5.3 to 10.4)
    Statistical analysis title
    		 Progression free survival
    Comparison groups
    Arm A : Bitherapy v Arm B : Monotherapy
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Response rate

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    End point title
    		 Response rate
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Arm B : Monotherapy Arm A : Bitherapy
    Number of subjects analysed
    44
    44
    Units: Percentage
    6
    24
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Median follow up was 34,3 months
    End point values
    		 Arm B : Monotherapy Arm A : Bitherapy
    Number of subjects analysed
    44
    44
    Units: Months
        median (confidence interval 95%)
    12.4 (8.2 to 19.6)
    16 (10.1 to 23.9)
    No statistical analyses for this end point

    Secondary: Quality of life EVA2

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    End point title
    		 Quality of life EVA2
    End point description
    Percentage of patient with improvement between baseline and EVA2
    End point type
    Secondary
    End point timeframe
    Between baseline and EVA2 (6 weeks after randomization)
    End point values
    		 Arm B : Monotherapy Arm A : Bitherapy
    Number of subjects analysed
    38
    35
    Units: Percentage
        Global health status
    30
    24
        Functional scales
    11
    27
        Physical functioning
    0
    24
        Role functioning
    17
    30
        Emotional functioning
    25
    45
        Cognitive functioning
    31
    21
        Social functioning
    20
    21
        Fatigue
    19
    21
        Nausea and vomiting
    17
    12
        Pain
    30
    30
        Dyspnoea
    22
    24
        Insomnia
    18
    24
        Appetite loss
    22
    15
        Constipation
    19
    15
        Diarrhoea
    11
    6
        Financial difficulties
    3
    6
    No statistical analyses for this end point

    Secondary: Quality of life EVA3

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    End point title
    		 Quality of life EVA3
    End point description
    Percentage of patients with improvement between Baseline and EVA3
    End point type
    Secondary
    End point timeframe
    Between randomization and EVA3 (12 weeks after randomization)
    End point values
    		 Arm B : Monotherapy Arm A : Bitherapy
    Number of subjects analysed
    26
    25
    Units: Percentage
        Global health status
    28
    9
        Functional scales
    8
    13
        Physical functioning
    0
    13
        Role functioning
    24
    13
        Emotional functioning
    40
    22
        Cognitive functioning
    24
    13
        Social functioning
    13
    22
        Fatigue
    28
    13
        Nausea and vomiting
    12
    17
        Pain
    36
    26
        Dyspnoea
    12
    17
        Insomnia
    40
    30
        Appetite loss
    20
    9
        Constipation
    12
    13
        Diarrhoea
    4
    4
        Financial difficulties
    4
    9
    No statistical analyses for this end point

    Secondary: Quality of life EVA4

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    End point title
    		 Quality of life EVA4
    End point description
    Percentage of patients with improvement between Baseline and EVA4
    End point type
    Secondary
    End point timeframe
    Bewteen randomization and EVA4 (18 weeks after randomization)
    End point values
    		 Arm B : Monotherapy Arm A : Bitherapy
    Number of subjects analysed
    18
    17
    Units: Percentage
        Global health status
    17
    0
        Functional scales
    17
    12
        Physical functioning
    28
    0
        Role functioning
    22
    6
        Emotional functioning
    22
    14
        Cognitive functioning
    17
    19
        Social functioning
    17
    12
        Fatigue
    39
    25
        Nausea and vomiting
    17
    25
        Pain
    55
    6
        Dyspnoea
    28
    0
        Insomnia
    22
    25
        Appetite loss
    11
    0
        Constipation
    0
    0
        Diarrhoea
    6
    12
        Financial difficulties
    6
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Median follow up was 34.3 months
    Adverse event reporting additional description
    Only grade 3 and 4
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTC
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 44 (40.91%)
    20 / 44 (45.45%)
         number of deaths (all causes)
    32
    36
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Motor activity retarded
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral edema
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    6 / 44 (13.64%)
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    6 / 44 (13.64%)
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Reduced general condition
         subjects affected / exposed
    2 / 44 (4.55%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Fall
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute renal failure
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth irritation
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial fistula
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hemoptysis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 44 (4.55%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnea
         subjects affected / exposed
    2 / 44 (4.55%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    2 / 44 (4.55%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumopathy
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tracheobronchial fistula
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Icterus
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusion
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 44 (93.18%)
    42 / 44 (95.45%)
    Investigations
    Increased gamma glutamyltransferase
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Nervous system disorders
    paresthesia
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 44 (0.00%)
         occurrences all number
    4
    0
    Leukopenia
         subjects affected / exposed
    1 / 44 (2.27%)
    2 / 44 (4.55%)
         occurrences all number
    1
    2
    Neutropenia
         subjects affected / exposed
    32 / 44 (72.73%)
    26 / 44 (59.09%)
         occurrences all number
    32
    26
    Febrile neutropenia
         subjects affected / exposed
    8 / 44 (18.18%)
    3 / 44 (6.82%)
         occurrences all number
    8
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 44 (9.09%)
    1 / 44 (2.27%)
         occurrences all number
    4
    1
    Dehydration
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    Vomiting
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    Diarrhoea
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 44 (0.00%)
         occurrences all number
    4
    0
    Constipation
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    mouth irritation
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Nail disorder
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 May 2009
    M1 tumours (several nodules in the same lung) are allowed to inclusion
    15 Jan 2010
    carboplatine allowed in patient previously treated with a cisplatin dose greater than 320 mg/m2

    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.
    Early termination leading to a small number of subjects analysed

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26059274
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