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    Clinical Trial Results:
    A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

    Summary
    EudraCT number
    		 2011-005537-39
    Trial protocol
    		 IT  
    Global end of trial date
    31 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Nov 2019
    First version publication date
    14 Nov 2019
    Other versions
    Summary report(s)
    		 LEGA Clinical Study Results

    Trial information

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    Trial identification
    Sponsor protocol code
    LEGA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02076594
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fondazione GISCAD
    Sponsor organisation address
    Via Gattinoni, 4, Vanzago (MI), Italy, 20010
    Public contact
    SILVIA ROTA, Fondazione Giscad, +39 02 84968409, CENTROTRIALGISCAD@YAHOO.IT
    Scientific contact
    SILVIA ROTA, Fondazione Giscad, +39 02 84968409, CENTROTRIALGISCAD@YAHOO.IT
    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 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the therapeutic efficacy of Docetaxel, Oxaliplatin and Capecitabine (low-TOX) vs. Epirubicin, Oxaliplatin and Capecitabine (EOX) as measured by the duration of Progression Free Survival (PFS)in patient with locally advanced/metastatic gastric cancer.
    Protection of trial subjects
    Study Protocol foresees that therapies considered necessary for the patient's well being might be given at the discretion of the Investigator, i.e chronic treatments for concomitant medical conditions, as well as agents required for life-threatening medical problems.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jan 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 169
    Worldwide total number of subjects
    169
    EEA total number of subjects
    169
    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)
    102
    From 65 to 84 years
    67
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study inclusion and exclusion criteria were assessed during the screening period, i.e within 28 days of study drug start. Recruitment was initiated in each country/at each site after respective legal and ethical approval.

    Pre-assignment
    Screening details
    		 169 patients were enrolled in the study. Among the whole enrolled population, five patients have never been treated so the total number of patients randomized and treated amounts to 164 units (82 per arm).

    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 1
    Arm description
    		 All patient treated with Docetaxel, Oxaliplatin and Capecitabine (low-TOX)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel + Oxaliplatin + Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    The treatment consisted of: -Docetaxel administered at 35 mg/ m2, intravenous at days 1 and 8 by 1-hour infusion; -Oxaliplatin administered at 80 mg/ m2, intravenous at day 1 by 2-hour infusion; -Capecitabine administered at 750 mg/ m2 (oral tablets of 500 and 150 mg) x2 daily for 2 weeks, followed by one week rest. Cycles were repeated every 3 weeks

    Arm title
    		 Arm 2
    Arm description
    		 All patient treated with Epirubicin + Oxaliplatin +Capecitabine (EOX)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Epirubicin + Oxaliplatin +Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    The treatment consisted of: -Epirubicin administered at 50 mg/ m2, intravenous on day 1 by 2-hour infusion; -Oxaliplatin administered at 130 mg/ m2, intravenous on day 1 by 2-hour infusion. -Capecitabine administered at 625 mg/ m2 (oral tablets of 500 and 150 mg) x2 daily for 3 weeks. Cycles were repeated every 3 weeks.

    Number of subjects in period 1 [1]
    		Arm 1 Arm 2
    Started
    82
    82
    Completed
    34
    37
    Not completed
    48
    45
         Progression disease
    23
    14
         Interruption in study drug administration for more
    5
    3
         Physician decision
    9
    -
         Investigator's decision
    -
    6
         Consent withdrawn by subject
    -
    5
         Initiation of new anticancer therapy
    2
    -
         Toxicity
    4
    10
         Death
    1
    3
         Intercurrent illness
    1
    1
         Patient's decision
    2
    3
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Among the whole enrolled population (169 patients), five patients have never been treated so the total number of patients randomized and treated amounts to 164 units (82 per arm).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 All patient treated with Docetaxel, Oxaliplatin and Capecitabine (low-TOX)

    Reporting group title
    Arm 2
    Reporting group description
    		 All patient treated with Epirubicin + Oxaliplatin +Capecitabine (EOX)

    Reporting group values
    		 Arm 1 Arm 2 Total
    Number of subjects
    		 82 82 164
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 45 54 99
        From 65-84 years
    		 37 28 65
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 64.0 (33.0 to 84.0) 61.0 (35.0 to 77.0) -
    Gender categorical
    Units: Subjects
        Female
    		 29 30 59
        Male
    		 53 52 105
    ECOG
    Units: Subjects
        Zero
    		 62 64 126
        One
    		 20 16 36
        Missing
    		 0 2 2
    Disease Extent at Study Entry
    Units: Subjects
        Locally advanced unresectable
    		 12 5 17
        Metastatic
    		 70 77 147
    Histological disease classification
    Units: Subjects
        Diffuse
    		 27 19 46
        Intestinal
    		 29 25 54
        Mix
    		 5 6 11
        Other
    		 19 28 47
        Missing
    		 2 4 6
    Histopathological Grade
    Units: Subjects
        G1
    		 1 1 2
        G2
    		 15 9 24
        G3
    		 34 51 85
        G4
    		 1 2 3
        GX
    		 9 1 10
        Unknown
    		 22 18 40
    Type of Prior Therapies Regimen
    Units: Subjects
        Surgery Alone
    		 19 14 33
        Surgery + Chemotherapy
    		 9 8 17
        Radiotherapy
    		 2 0 2
        Surgery + Chemotherapy + Radiotherapy
    		 4 1 5
        Unknown/Not Done
    		 48 59 107

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 All patient treated with Docetaxel, Oxaliplatin and Capecitabine (low-TOX)

    Reporting group title
    Arm 2
    Reporting group description
    		 All patient treated with Epirubicin + Oxaliplatin +Capecitabine (EOX)

    Subject analysis set title
    All patient treated with Docetaxel + Oxaliplatin +Capecitabine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Arm 1_All subject treated with Docetaxel + Oxaliplatin + Capecitabine (low-TOX)

    Subject analysis set title
    All patient treate with Epirubicin + Oxaliplatin +Capecitabine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Arm 2_All patient treated with Epirubicin + Oxaliplatin +Capecitabine

    Primary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Progression Free Survival (PFS) was defined as the time from randomization to the date of local or regional progression, distant metastasis, second primary malignancy or death from any cause, whichever comes first.
    End point type
    Primary
    End point timeframe
    The time from randomization to the date of local or regional progression, distant metastasis, second primary malignancy or death from any cause, whichever comes first.
    End point values
    		 All patient treated with Docetaxel + Oxaliplatin +Capecitabine All patient treate with Epirubicin + Oxaliplatin +Capecitabine
    Number of subjects analysed
    82
    82
    Units: Months
        median (confidence interval 95%)
    6.3 (5.0 to 7.8)
    6.3 (5.0 to 8.1)
    Statistical analysis title
    		 Survival curves comparison
    Comparison groups
    All patient treated with Docetaxel + Oxaliplatin +Capecitabine v All patient treate with Epirubicin + Oxaliplatin +Capecitabine
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.983
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - Log-Rank Test stratified by performance status

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall Survival (OS) is defined as the time from randomization to the date of death from any cause. Subjects who have not died while on study or have been lost to follow up were consored at the last contact date.
    End point type
    Secondary
    End point timeframe
    Overall Survival (OS) is defined as the time from randomization to the date of death or date when the patient is lastly known alive.
    End point values
    		 All patient treated with Docetaxel + Oxaliplatin +Capecitabine All patient treate with Epirubicin + Oxaliplatin +Capecitabine
    Number of subjects analysed
    82
    82
    Units: Months
        median (confidence interval 95%)
    11.5 (8.6 to 15.0)
    12.4 (9.1 to 19.2)
    Statistical analysis title
    		 Survival curves comparison
    Comparison groups
    All patient treate with Epirubicin + Oxaliplatin +Capecitabine v All patient treated with Docetaxel + Oxaliplatin +Capecitabine
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.838
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - Log-Rank test stratified by performance status

    Secondary: Objective Response Rate (CR+PR)

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    End point title
    		 Objective Response Rate (CR+PR)
    End point description
    Objective tumor response rate (ORR) is defined as the number of subjects whose best response to treatment achieved during study is CR (completed response) or PR (partial response), as evaluated by the RECIST 1.1 criteria, over the number of randomized patients.
    End point type
    Secondary
    End point timeframe
    During all study period
    End point values
    		 All patient treated with Docetaxel + Oxaliplatin +Capecitabine All patient treate with Epirubicin + Oxaliplatin +Capecitabine
    Number of subjects analysed
    82
    82
    Units: percent
        number (confidence interval 95%)
    24.4 (16.4 to 34.7)
    32.9 (23.7 to 43.7)
    Statistical analysis title
    		 Treatment response comparison
    Statistical analysis description
    Analysis performed by Mantel-Haenszlel Chi-Square Test controlling for ECOG Performance Status
    Comparison groups
    All patient treated with Docetaxel + Oxaliplatin +Capecitabine v All patient treate with Epirubicin + Oxaliplatin +Capecitabine
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.209
    Method
    		 Mantel-Haenszel
    Confidence interval

    Secondary: Disease control rate (DCR)

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    End point title
    		 Disease control rate (DCR)
    End point description
    Disease control rate (DCR) is defined as the number of subjects whose best response is CR (Complete Response) ,PR (Partial Response) or SD (Stable Disease) lasting = or > 12 weeks, over the number of randomized patients.
    End point type
    Secondary
    End point timeframe
    During all study period
    End point values
    		 All patient treated with Docetaxel + Oxaliplatin +Capecitabine All patient treate with Epirubicin + Oxaliplatin +Capecitabine
    Number of subjects analysed
    82
    82
    Units: percent
        number (confidence interval 95%)
    67.1 (56.3 to 76.3)
    68.3 (57.6 to 77.4)
    Statistical analysis title
    		 Treatment response comparison
    Statistical analysis description
    Analysis performed by Mantel-Haenszel Chi-Square Test controlling for ECOG Performance Status
    Comparison groups
    All patient treate with Epirubicin + Oxaliplatin +Capecitabine v All patient treated with Docetaxel + Oxaliplatin +Capecitabine
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.975
    Method
    		 Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During all study period and followed until 28 days after the last dose of investigational product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Arm1
    Reporting group description
    		 -

    Reporting group title
    Arm 2
    Reporting group description
    		 -

    Serious adverse events
    		 Arm1 Arm 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 82 (29.27%)
    15 / 82 (18.29%)
         number of deaths (all causes)
    59
    55
         number of deaths resulting from adverse events
    0
    2
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Condition aggravated
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fatigue
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    generalized oedema
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 82 (3.66%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachypnoea
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (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
    Cerebral ischaemia
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 82 (3.66%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eyelid ptosis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 82 (4.88%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 82 (0.00%)
    2 / 82 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 82 (3.66%)
    3 / 82 (3.66%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (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
    Back pain
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Candidiasis
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm1 Arm 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 82 (95.12%)
    74 / 82 (90.24%)
    Investigations
    Weight decreased
         subjects affected / exposed
    8 / 82 (9.76%)
    3 / 82 (3.66%)
         occurrences all number
    11
    3
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    9 / 82 (10.98%)
    4 / 82 (4.88%)
         occurrences all number
    24
    5
    Neuropathy peripheral
         subjects affected / exposed
    16 / 82 (19.51%)
    15 / 82 (18.29%)
         occurrences all number
    36
    36
    Paraesthesia
         subjects affected / exposed
    3 / 82 (3.66%)
    5 / 82 (6.10%)
         occurrences all number
    7
    18
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    20 / 82 (24.39%)
    28 / 82 (34.15%)
         occurrences all number
    49
    71
    Leukopenia
         subjects affected / exposed
    10 / 82 (12.20%)
    21 / 82 (25.61%)
         occurrences all number
    22
    47
    Lymphopenia
         subjects affected / exposed
    4 / 82 (4.88%)
    9 / 82 (10.98%)
         occurrences all number
    8
    18
    Neutropenia
         subjects affected / exposed
    18 / 82 (21.95%)
    33 / 82 (40.24%)
         occurrences all number
    37
    79
    Thrombocytopenia
         subjects affected / exposed
    3 / 82 (3.66%)
    10 / 82 (12.20%)
         occurrences all number
    6
    19
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    39 / 82 (47.56%)
    29 / 82 (35.37%)
         occurrences all number
    116
    71
    Mucosal inflammation
         subjects affected / exposed
    18 / 82 (21.95%)
    6 / 82 (7.32%)
         occurrences all number
    39
    9
    Oedema peripheral
         subjects affected / exposed
    5 / 82 (6.10%)
    3 / 82 (3.66%)
         occurrences all number
    8
    3
    Pyrexia
         subjects affected / exposed
    11 / 82 (13.41%)
    9 / 82 (10.98%)
         occurrences all number
    16
    10
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    8 / 82 (9.76%)
    0 / 82 (0.00%)
         occurrences all number
    14
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    18 / 82 (21.95%)
    17 / 82 (20.73%)
         occurrences all number
    31
    35
    Constipation
         subjects affected / exposed
    14 / 82 (17.07%)
    13 / 82 (15.85%)
         occurrences all number
    23
    20
    Diarrhoea
         subjects affected / exposed
    38 / 82 (46.34%)
    24 / 82 (29.27%)
         occurrences all number
    76
    37
    Dyspepsia
         subjects affected / exposed
    5 / 82 (6.10%)
    2 / 82 (2.44%)
         occurrences all number
    6
    2
    Dysphagia
         subjects affected / exposed
    5 / 82 (6.10%)
    2 / 82 (2.44%)
         occurrences all number
    9
    6
    Nausea
         subjects affected / exposed
    37 / 82 (45.12%)
    31 / 82 (37.80%)
         occurrences all number
    72
    61
    Vomiting
         subjects affected / exposed
    25 / 82 (30.49%)
    21 / 82 (25.61%)
         occurrences all number
    37
    30
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 82 (8.54%)
    3 / 82 (3.66%)
         occurrences all number
    10
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    10 / 82 (12.20%)
    9 / 82 (10.98%)
         occurrences all number
    29
    40
    Erythema
         subjects affected / exposed
    12 / 82 (14.63%)
    1 / 82 (1.22%)
         occurrences all number
    22
    3
    Nail disorder
         subjects affected / exposed
    5 / 82 (6.10%)
    0 / 82 (0.00%)
         occurrences all number
    14
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    22 / 82 (26.83%)
    9 / 82 (10.98%)
         occurrences all number
    54
    31
    Rash
         subjects affected / exposed
    8 / 82 (9.76%)
    1 / 82 (1.22%)
         occurrences all number
    14
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 82 (2.44%)
    5 / 82 (6.10%)
         occurrences all number
    2
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    19 / 82 (23.17%)
    11 / 82 (13.41%)
         occurrences all number
    44
    19
    Hypocalcaemia
         subjects affected / exposed
    6 / 82 (7.32%)
    1 / 82 (1.22%)
         occurrences all number
    7
    2
    Hypoalbuminaemia
         subjects affected / exposed
    5 / 82 (6.10%)
    2 / 82 (2.44%)
         occurrences all number
    7
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2013
    This is an administrative amendment to notify that effective from November 1, 2012, Nerviano Medical Sciences S.r.l. (NMS), CRO delegated for the experimentation, conferred its business branch, including the activities carried out by its Business Unit - Department of Clinical Development "Milano International Oncology" (MIO), to the company CLIOSS Srl. Therefore, all the activities previously delegated to MIO have been transferred to CLIOSS Srl. The documents Protocol and Informed Consent have been modified with the new name of the CRO.
    12 Jun 2015
    The substantial amendment to the protocol was necessary due to the recruitment of fewer patients than expected in all the centers involved. The primary endpoint was changed: the analysis focused on disease-free survival (PFS) based on suggestions from the Regulatory Authority.

    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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