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    Clinical Trial Results:
    Nal-IRI/LV5-FU VERSUS PACLITAXEL AS SECOND-LINE THERAPY IN PATIENTS WITH METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA

    Summary
    EudraCT number
    		 2017-004730-28
    Trial protocol
    		 FR  
    Global end of trial date
    30 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2026
    First version publication date
    02 Jan 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PRODIGE 62
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03719924
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fédération Francophone de Cancérologie Digestive
    Sponsor organisation address
    7 bd Jeanne d'Arc, Dijon, France,
    Public contact
    Head of Biostatistics, Fédération Francophone de Cancérologie Digestive (FFCD), +33 380393483, karine.le-malicot@u-bourgogne.fr
    Scientific contact
    Clinical project manager, Fédération Francophone de Cancérologie Digestive (FFCD), +33 380393483, lila.gaba@u-bourgogne.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
    29 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the survival of patients at 9 months
    Protection of trial subjects
    This trial was conducted in accordance with the New European Directive 2001/20/EC. The investigator undertook to obtain the patient's consent for the clinical and biological studies in writing, after providing adequate information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Mar 2019
    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: 106
    Worldwide total number of subjects
    106
    EEA total number of subjects
    106
    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)
    51
    From 65 to 84 years
    55
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Between March 7th, 2019 and July 5th, 2023, 106 patients in 43 centers were randomized (53 patients in each arm)

    Pre-assignment
    Screening details
    		 Main inclusion criteria were patients aged 18 years or older, histologically proven mESCC, with progression or intolerance after 1st line platinum-based CT. Patients with resectable disease treated with surgery and pre- or post-operative CT could be included if a metastatic recurrence occurred within 6 month after end of treatment

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bras A - Nal-IRI plus LV5FU
    Arm description
    		 Patients received the 5FU Nal-IRI regimen with folinic acid 400 mg/ m2 in a 2-hour intravenous (IV) infusion, continuous 5FU 2400 mg/m2 in a 46-hour IV infusion and nal-iri at 70 mg/m² in a 2-hour IV infusion, every 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    5FU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    continuous 5FU 2400 mg/m2 in a 46-hour IV infusion every 14 days

    Investigational medicinal product name
    Nal-Iri
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    nal-iri at 70 mg/m² in a 2-hour IV infusion, every 14 days

    Arm title
    		 Bras B - Paclitaxel
    Arm description
    		 In the control arm, paclitaxel was administered at a dose of 80 mg/m2 at day 1, day 8 and day 14 of a 28-day cycle
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered at a dose of 80 mg/m2 at day 1, day 8 and day 14 of a 28-day cycle

    Number of subjects in period 1
    		Bras A - Nal-IRI plus LV5FU Bras B - Paclitaxel
    Started
    53
    53
    Completed
    50
    51
    Not completed
    3
    2
         Not treatedreated
    -
    2
         Not treated
    3
    -
    Period 2
    Period 2 title
    Treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bras A - Nal-IRI plus LV5FU
    Arm description
    		 Patients received the 5FU Nal-IRI regimen with folinic acid 400 mg/ m2 in a 2-hour intravenous (IV) infusion, continuous 5FU 2400 mg/m2 in a 46-hour IV infusion and nal-iri at 70 mg/m² in a 2-hour IV infusion, every 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    5FU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    continuous 5FU 2400 mg/m2 in a 46-hour IV infusion every 14 days

    Investigational medicinal product name
    Nal-Iri
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    nal-iri at 70 mg/m² in a 2-hour IV infusion, every 14 days

    Investigational medicinal product name
    5FU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    continuous 5FU 2400 mg/m2 in a 46-hour IV infusion every 14 days

    Arm title
    		 Bras B - Paclitaxel
    Arm description
    		 In the control arm, paclitaxel was administered at a dose of 80 mg/m2 at day 1, day 8 and day 14 of a 28-day cycle
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered at a dose of 80 mg/m2 at day 1, day 8 and day 14 of a 28-day cycle

    Number of subjects in period 2
    		Bras A - Nal-IRI plus LV5FU Bras B - Paclitaxel
    Started
    50
    51
    Completed
    50
    51
    Period 3
    Period 3 title
    Safety Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bras A - Nal-IRI plus LV5FU/5FU
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    5FU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    continuous 5FU 2400 mg/m2 in a 46-hour IV infusion every 14 days

    Arm title
    		 Bras B - Paclitaxel
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered at a dose of 80 mg/m2 at day 1, day 8 and day 14 of a 28-day cycle

    Number of subjects in period 3
    		Bras A - Nal-IRI plus LV5FU/5FU Bras B - Paclitaxel
    Started
    49
    52
    Completed
    49
    52

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bras A - Nal-IRI plus LV5FU
    Reporting group description
    		 Patients received the 5FU Nal-IRI regimen with folinic acid 400 mg/ m2 in a 2-hour intravenous (IV) infusion, continuous 5FU 2400 mg/m2 in a 46-hour IV infusion and nal-iri at 70 mg/m² in a 2-hour IV infusion, every 14 days.

    Reporting group title
    Bras B - Paclitaxel
    Reporting group description
    		 In the control arm, paclitaxel was administered at a dose of 80 mg/m2 at day 1, day 8 and day 14 of a 28-day cycle

    Reporting group values
    		 Bras A - Nal-IRI plus LV5FU Bras B - Paclitaxel Total
    Number of subjects
    		 53 53 106
    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)
    		 25 26 51
        From 65-84 years
    		 28 27 55
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 66.8 (60.6 to 71.7) 65.1 (59.7 to 70.4) -
    Gender categorical
    Units: Subjects
        Female
    		 7 11 18
        Male
    		 46 42 88
    Subject analysis sets

    Subject analysis set title
    mITT set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Analyses of primary and secondary efficacy endpoints were conducted on the modified intention-to-treat population (mITT population), i.e. all patients who had received at least one dose of treatment in the study, regardless of their eligibility criteria

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analyses were conducted on all patients receiving at least one dose of treatment and according to the treatment received

    Subject analysis sets values
    		 mITT set Safety set
    Number of subjects
    101
    101
    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)
    48
    48
        From 65-84 years
    53
    53
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    66 (60 to 71.2)
    66 (60 to 71.2)
    Gender categorical
    Units: Subjects
        Female
    18
    18
        Male
    83
    83

    End points

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    End points reporting groups
    Reporting group title
    Bras A - Nal-IRI plus LV5FU
    Reporting group description
    		 Patients received the 5FU Nal-IRI regimen with folinic acid 400 mg/ m2 in a 2-hour intravenous (IV) infusion, continuous 5FU 2400 mg/m2 in a 46-hour IV infusion and nal-iri at 70 mg/m² in a 2-hour IV infusion, every 14 days.

    Reporting group title
    Bras B - Paclitaxel
    Reporting group description
    		 In the control arm, paclitaxel was administered at a dose of 80 mg/m2 at day 1, day 8 and day 14 of a 28-day cycle
    Reporting group title
    Bras A - Nal-IRI plus LV5FU
    Reporting group description
    		 Patients received the 5FU Nal-IRI regimen with folinic acid 400 mg/ m2 in a 2-hour intravenous (IV) infusion, continuous 5FU 2400 mg/m2 in a 46-hour IV infusion and nal-iri at 70 mg/m² in a 2-hour IV infusion, every 14 days.

    Reporting group title
    Bras B - Paclitaxel
    Reporting group description
    		 In the control arm, paclitaxel was administered at a dose of 80 mg/m2 at day 1, day 8 and day 14 of a 28-day cycle
    Reporting group title
    Bras A - Nal-IRI plus LV5FU/5FU
    Reporting group description
    		 -

    Reporting group title
    Bras B - Paclitaxel
    Reporting group description
    		 -

    Subject analysis set title
    mITT set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Analyses of primary and secondary efficacy endpoints were conducted on the modified intention-to-treat population (mITT population), i.e. all patients who had received at least one dose of treatment in the study, regardless of their eligibility criteria

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analyses were conducted on all patients receiving at least one dose of treatment and according to the treatment received

    Primary: Rate of patients alive 9 months after randomisation[

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    End point title
    		 Rate of patients alive 9 months after randomisation[ [1]
    End point description
    The primary endpoint was defined as the rate of patients alive 9-month after randomization. This rate of patients alive at 9 months was assessed based on the time between the patient's randomization date and the date of death (regardless of the cause). Alive patients were censored at the date of their last news.
    End point type
    Primary
    End point timeframe
    9 months after randomization
    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: The study was a non-comparative study that's why no statistical analysis was done.
    End point values
    		 Bras A - Nal-IRI plus LV5FU Bras B - Paclitaxel
    Number of subjects analysed
    50
    51
    Units: patients
        Patients alive at 9 months
    17
    20
        Patients dead at 9 months
    33
    31
    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
    The progression-free-survival was defined as the time from the randomization to the first clinical/radiological progression (according to RECIST 1.1 criteria) or the date of the death from any cause. Patient alive were censored at the date of the last news.
    End point type
    Secondary
    End point timeframe
    6 months after randomization
    End point values
    		 Bras A - Nal-IRI plus LV5FU Bras B - Paclitaxel
    Number of subjects analysed
    50
    51
    Units: months
        median (inter-quartile range (Q1-Q3))
    2.4 (2.1 to 3.6)
    2.1 (1.9 to 3.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected before each cycle of chemotherapy systematically during the whole protocol of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTC
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Bras A - Nal-IRI plus LV5FU
    Reporting group description
    		 -

    Reporting group title
    Bras B - Paclitaxel
    Reporting group description
    		 -

    Serious adverse events
    		 Bras A - Nal-IRI plus LV5FU Bras B - Paclitaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 49 (53.06%)
    15 / 52 (28.85%)
         number of deaths (all causes)
    33
    31
         number of deaths resulting from adverse events
    5
    4
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight loss
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinusal Tachycardia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac Thoracic pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    4 / 49 (8.16%)
    6 / 52 (11.54%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Fever
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Discomfort
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (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
    5 / 49 (10.20%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomach pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastro-intestinal hemorraghe
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Inflammation of the lining of the small intestine
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (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
    2 / 49 (4.08%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Voice alteration
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonite
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Enterocolitis infectious
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site infection
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary infection
         subjects affected / exposed
    3 / 49 (6.12%)
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatremia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bras A - Nal-IRI plus LV5FU Bras B - Paclitaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 49 (97.96%)
    51 / 52 (98.08%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    10 / 49 (20.41%)
    14 / 52 (26.92%)
         occurrences all number
    10
    14
    Bilirubin increased
         subjects affected / exposed
    2 / 49 (4.08%)
    5 / 52 (9.62%)
         occurrences all number
    2
    5
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    15 / 49 (30.61%)
    18 / 52 (34.62%)
         occurrences all number
    15
    18
    White blood cell count decreased
         subjects affected / exposed
    15 / 49 (30.61%)
    17 / 52 (32.69%)
         occurrences all number
    15
    17
    Lymphocytes decreased
         subjects affected / exposed
    8 / 49 (16.33%)
    21 / 52 (40.38%)
         occurrences all number
    8
    21
    Weight loss
         subjects affected / exposed
    6 / 49 (12.24%)
    3 / 52 (5.77%)
         occurrences all number
    6
    3
    Phosphatases alcalines increased
         subjects affected / exposed
    8 / 49 (16.33%)
    16 / 52 (30.77%)
         occurrences all number
    8
    16
    Platelets decreased
         subjects affected / exposed
    8 / 49 (16.33%)
    9 / 52 (17.31%)
         occurrences all number
    8
    9
    Nervous system disorders
    Dysgueusia
         subjects affected / exposed
    5 / 49 (10.20%)
    3 / 52 (5.77%)
         occurrences all number
    5
    3
    Neuropathy peripheral sensitive
         subjects affected / exposed
    16 / 49 (32.65%)
    25 / 52 (48.08%)
         occurrences all number
    16
    25
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    29 / 49 (59.18%)
    36 / 52 (69.23%)
         occurrences all number
    29
    36
    General disorders and administration site conditions
    Non cardiac thoracic pain
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 52 (5.77%)
         occurrences all number
    2
    3
    Fatigue
         subjects affected / exposed
    29 / 49 (59.18%)
    35 / 52 (67.31%)
         occurrences all number
    29
    35
    Fever
         subjects affected / exposed
    5 / 49 (10.20%)
    6 / 52 (11.54%)
         occurrences all number
    5
    6
    Limb edema
         subjects affected / exposed
    1 / 49 (2.04%)
    4 / 52 (7.69%)
         occurrences all number
    1
    4
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    6 / 49 (12.24%)
    7 / 52 (13.46%)
         occurrences all number
    6
    7
    Diarrhoea
         subjects affected / exposed
    34 / 49 (69.39%)
    17 / 52 (32.69%)
         occurrences all number
    34
    17
    Abdominal pain
         subjects affected / exposed
    9 / 49 (18.37%)
    1 / 52 (1.92%)
         occurrences all number
    9
    1
    Stomach pain
         subjects affected / exposed
    1 / 49 (2.04%)
    6 / 52 (11.54%)
         occurrences all number
    1
    6
    Dysphagia
         subjects affected / exposed
    8 / 49 (16.33%)
    12 / 52 (23.08%)
         occurrences all number
    8
    12
    Mucositis
         subjects affected / exposed
    9 / 49 (18.37%)
    9 / 52 (17.31%)
         occurrences all number
    9
    9
    Nausea
         subjects affected / exposed
    24 / 49 (48.98%)
    16 / 52 (30.77%)
         occurrences all number
    24
    16
    Vomiting
         subjects affected / exposed
    13 / 49 (26.53%)
    9 / 52 (17.31%)
         occurrences all number
    13
    9
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    9 / 49 (18.37%)
    9 / 52 (17.31%)
         occurrences all number
    9
    9
    Cough
         subjects affected / exposed
    5 / 49 (10.20%)
    8 / 52 (15.38%)
         occurrences all number
    5
    8
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 52 (5.77%)
         occurrences all number
    2
    3
    Musculoskeletal and connective tissue disorders
    Dorsalgia
         subjects affected / exposed
    2 / 49 (4.08%)
    5 / 52 (9.62%)
         occurrences all number
    2
    5
    Myalgia
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 52 (7.69%)
         occurrences all number
    2
    4
    Infections and infestations
    Bronchial infection
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 52 (5.77%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    18 / 49 (36.73%)
    10 / 52 (19.23%)
         occurrences all number
    18
    10
    Hyperkaliemia
         subjects affected / exposed
    4 / 49 (8.16%)
    5 / 52 (9.62%)
         occurrences all number
    4
    5
    Hypoalbuminemia
         subjects affected / exposed
    6 / 49 (12.24%)
    7 / 52 (13.46%)
         occurrences all number
    6
    7
    Hypocalcemia
         subjects affected / exposed
    4 / 49 (8.16%)
    3 / 52 (5.77%)
         occurrences all number
    4
    3
    Hyponatremia
         subjects affected / exposed
    5 / 49 (10.20%)
    3 / 52 (5.77%)
         occurrences all number
    5
    3

    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/4087608
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