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    Clinical Trial Results:
    A randomized multicenter phase II trial of a sequential chemotherapy of nab-paclitaxel + gemcitabine followed by FOLFIRI.3 versus nab-paclitaxel + gemcitabine in first line of pancreatic adenocarcinoma

    Summary
    EudraCT number
    		 2014-004449-28
    Trial protocol
    		 FR  
    Global end of trial date
    31 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Aug 2025
    First version publication date
    03 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PRODIGE 37
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02827201
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fédération Francophone de Cancérologie Digestive (FFCD)
    Sponsor organisation address
    7 Boulevard Jeanne d’Arc, BP 87900, Dijon, France, 21079
    Public contact
    Marie Moreau, Fédération Francophone de Cancérologie Digestive (FFCD), +33 0755676632, marie.moreau@u-bourgogne.fr
    Scientific contact
    Marie Moreau, Fédération Francophone de Cancérologie Digestive (FFCD), +33 0755676632, marie.moreau@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
    20 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Patient rate in live and without radiological and/or clinical progression at 6 months after randomization
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki, ICH requirements and Good Clinical Practice guidelines; it received authorization from the French national medicines agency (ASNM), and independent ethics committee. The study was registered in clinical trials.gov (NCT02827201). All patients provided their written informed consent before the initiation of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Apr 2015
    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: 127
    Worldwide total number of subjects
    127
    EEA total number of subjects
    127
    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)
    52
    From 65 to 84 years
    75
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between November 2015 and November 2016, 127 patients were enrolled in the trial by 36 french centres.

    Pre-assignment
    Screening details
    		 Baseline computerised tomography (CT) scan, or magnetic resonance imaging (MRI), was performed within 3 weeks before the start of treatment. In the week preceding the start of treatment, patients underwent medical history evaluation, physical examination, assessment of health-related quality of life (QoL), electrocardiogram, biological assessment.

    Period 1
    Period 1 title
    Baseline period (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 A : GN + FOLFIRI.3
    Arm description
    		 gemcitabine + nab-paclitaxel + FOLFIRI.3 =FIRGEMAX arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate and solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m2 I.V. for 30 min for a total of six doses on days 1, 8, 15, 29, 36 and 43

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2 months of nab-paclitaxel (125 mg/m2) I.V. for 30 min immediately followed by gemcitabine (1000 mg/m2) I.V. for 30 min, for a total of six doses on days 1, 8, 15, 29, 36 and 43.

    Investigational medicinal product name
    FOLFIRI.3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    After 2 months of nab-paclitaxel + Gemcitabine, FOLFIRI.3 sequence : irinotecan 90 mg/m2 I.V. for 60 min on D1, together with folinic acid 400 mg/m2 given as a 2-h I.V. infusion, immediately followed by continuous fluorouracil (5-FU) infusion at a dose of 2000 mg/m2 over a 46-h period, and irinotecan, 90 mg/m2 I.V. for 60 min repeated on D3 at the end of the 5-FU infusion. The chemotherapy cycles were repeated every 14 days for 2 months. This sequence (gemcitabine + nab-paclitaxel followed by FOLFIRI.3) was repeated until disease progression or limiting toxicity.

    Arm title
    		 arm B : GN
    Arm description
    		 gemcitabine + nab-paclitaxel (standard first-line therapy)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel = 125 mg/m2 I.V. for 30 min. Gemcitabine + nab-paclitaxel were given until disease progression, unacceptable toxicity or patient refusal.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate and solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine = 1000 mg/m2 I.V. for 30 min. gemcitabine + nab-paclitaxel were given until disease progression, unacceptable toxicity or patient refusal.

    Number of subjects in period 1
    		arm A : GN + FOLFIRI.3 arm B : GN
    Started
    64
    63
    Completed
    62
    60
    Not completed
    2
    3
         Patient not treated
    1
    1
         Death
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    arm A : GN + FOLFIRI.3
    Reporting group description
    		 gemcitabine + nab-paclitaxel + FOLFIRI.3 =FIRGEMAX arm

    Reporting group title
    arm B : GN
    Reporting group description
    		 gemcitabine + nab-paclitaxel (standard first-line therapy)

    Reporting group values
    		 arm A : GN + FOLFIRI.3 arm B : GN Total
    Number of subjects
    		 64 63 127
    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)
    		 30 30 60
        From 65-84 years
    		 34 33 67
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 63.5 (38.3 to 76.0) 64.1 (41.0 to 76.0) -
    Gender categorical
    Units: Subjects
        Female
    		 28 34 62
        Male
    		 36 29 65
    ECOG PS
    Units: Subjects
        PS 0
    		 24 23 47
        PS 1
    		 33 32 65
        PS 2
    		 7 8 15
    Nb of metastatic sites
    Units: Subjects
        One
    		 29 37 66
        > 1
    		 35 26 61
    Previous surgery
    Units: Subjects
        Yes
    		 8 3 11
        No
    		 56 60 116
    Previous radiotherapy
    Units: Subjects
        Yes
    		 0 2 2
        No
    		 64 61 125
    Previous chemotheray
    Units: Subjects
        Yes
    		 7 3 10
        No
    		 57 60 117
    CA 19.9
    Units: UI/mL
        median (full range (min-max))
    		 1346 (0.8 to 131600) 5575 (0.6 to 534806) -
    Subject analysis sets

    Subject analysis set title
    mITT (arm A : GN + FOLFIRI.3)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Randomised patients receiving at least one dose of treatment in arm A

    Subject analysis set title
    mITT (arm B : GN)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Randomised patients receiving at least one dose of treatment in arm B

    Subject analysis sets values
    		 mITT (arm A : GN + FOLFIRI.3) mITT (arm B : GN)
    Number of subjects
    62
    60
    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)
    29
    29
        From 65-84 years
    33
    31
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    63.3 (38.3 to 76.0)
    64.1 (41.0 to 76.0)
    Gender categorical
    Units: Subjects
        Female
    28
    32
        Male
    34
    28
    ECOG PS
    Units: Subjects
        PS 0
    24
    22
        PS 1
    31
    31
        PS 2
    7
    7
    Nb of metastatic sites
    Units: Subjects
        One
    28
    35
        > 1
    34
    25
    Previous surgery
    Units: Subjects
        Yes
    8
    3
        No
    54
    57
    Previous radiotherapy
    Units: Subjects
        Yes
    0
    2
        No
    62
    58
    Previous chemotheray
    Units: Subjects
        Yes
    7
    3
        No
    55
    57
    CA 19.9
    Units: UI/mL
        median (full range (min-max))
    1067 (0.8 to 131600)
    4358.5 (0.6 to 534806)

    End points

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    End points reporting groups
    Reporting group title
    arm A : GN + FOLFIRI.3
    Reporting group description
    		 gemcitabine + nab-paclitaxel + FOLFIRI.3 =FIRGEMAX arm

    Reporting group title
    arm B : GN
    Reporting group description
    		 gemcitabine + nab-paclitaxel (standard first-line therapy)

    Subject analysis set title
    mITT (arm A : GN + FOLFIRI.3)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Randomised patients receiving at least one dose of treatment in arm A

    Subject analysis set title
    mITT (arm B : GN)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Randomised patients receiving at least one dose of treatment in arm B

    Primary: PFS rate at 6 months

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    End point title
    		 PFS rate at 6 months [1]
    End point description
    The primary end point was 6-month PFS rate based on TDM. In the 62 mITT patients in arm A: If 32 or more patients are alive without progression at 6 months, we conclude that the treatment is effective.
    End point type
    Primary
    End point timeframe
    at 6 months post 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: This is a non-comparative study, so there are no inferential statistics.
    End point values
    		 mITT (arm A : GN + FOLFIRI.3) mITT (arm B : GN)
    Number of subjects analysed
    62
    60
    Units: patients
        Yes
    28
    14
        No
    34
    46
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Progression free-survival was measured from the date of randomization to the date of first progression (radiological or clinical) or the date of death from any cause. Alive patients free of progression were censored at the date of the last follow-up visit.
    End point type
    Secondary
    End point timeframe
    until the last follow-up or the apperance of progression or death
    End point values
    		 mITT (arm A : GN + FOLFIRI.3) mITT (arm B : GN)
    Number of subjects analysed
    62
    60
    Units: months
        median (confidence interval 95%)
    6.1 (3.7 to 7.6)
    4.2 (2.4 to 6.0)
    Attachments
    		 PFS_mITT
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival was defined as the time between randomization and death (all causes). Patients alive were censored at the last follow-up.
    End point type
    Secondary
    End point timeframe
    until the end of the follow-up or death (Whatever the cause)
    End point values
    		 mITT (arm A : GN + FOLFIRI.3) mITT (arm B : GN)
    Number of subjects analysed
    62
    60
    Units: months
        median (confidence interval 95%)
    11.8 (8.8 to 15.0)
    11.2 (8.2 to 13.2)
    Attachments
    		 OS_mITT
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    End point type
    Secondary
    End point timeframe
    All tumour assessments carried out between study start and D1 of the last treatment (+1.5 months) received by every patient
    End point values
    		 mITT (arm A : GN + FOLFIRI.3) mITT (arm B : GN)
    Number of subjects analysed
    62
    60
    Units: %
        number (confidence interval 95%)
    40.3 (28.1 to 53.6)
    26.7 (16.1 to 39.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (related and unrelated, expected and unexpected) were collected after each cycles of treatment until the end of the treatment period.
    Adverse event reporting additional description
    Adverse events were analyzed on the population of patients who received at least one dose of treatment and regarding the treatment really received by the patient (Two patients randomized in the GN arm received GN + FOLFIRI.3 and so were analyzed in GN + FOLFIRI.3 for tolerance)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTC
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    arm A : GN + FOLFIRI.3
    Reporting group description
    		 -

    Reporting group title
    arm B :GN
    Reporting group description
    		 -

    Serious adverse events
    		 arm A : GN + FOLFIRI.3 arm B :GN
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 64 (56.25%)
    24 / 58 (41.38%)
         number of deaths (all causes)
    53
    54
         number of deaths resulting from adverse events
    4
    5
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    9 / 64 (14.06%)
    5 / 58 (8.62%)
         occurrences causally related to treatment / all
    3 / 9
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    3 / 64 (4.69%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (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
    Bronchopneumopathy
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Lung disorder
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Angiocardiogram
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (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
    Accidental overdose
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac failure
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Myocardial infarction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (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
    Cerebrovascular accident
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Transient ischaemic attack
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone marrow failure
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile bone marrow aplasia
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subileus
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 64 (4.69%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    4 / 64 (6.25%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal obstruction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Biliary tract disorder
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis bullous
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin toxicity
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Campylobacter colitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    4 / 64 (6.25%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 58 (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
    		 arm A : GN + FOLFIRI.3 arm B :GN
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    63 / 64 (98.44%)
    58 / 58 (100.00%)
    Vascular disorders
    Venous thromboembolic event
         subjects affected / exposed
    10 / 64 (15.63%)
    6 / 58 (10.34%)
         occurrences all number
    10
    6
    Hypertension
         subjects affected / exposed
    1 / 64 (1.56%)
    3 / 58 (5.17%)
         occurrences all number
    1
    3
    General disorders and administration site conditions
    Dyspepsia
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    Fatigue
         subjects affected / exposed
    52 / 64 (81.25%)
    45 / 58 (77.59%)
         occurrences all number
    52
    45
    Fever
         subjects affected / exposed
    24 / 64 (37.50%)
    18 / 58 (31.03%)
         occurrences all number
    24
    18
    Oedema of the limbs
         subjects affected / exposed
    16 / 64 (25.00%)
    14 / 58 (24.14%)
         occurrences all number
    16
    14
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    6 / 64 (9.38%)
    4 / 58 (6.90%)
         occurrences all number
    6
    4
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    Epistaxis
         subjects affected / exposed
    6 / 64 (9.38%)
    3 / 58 (5.17%)
         occurrences all number
    6
    3
    Cough
         subjects affected / exposed
    2 / 64 (3.13%)
    7 / 58 (12.07%)
         occurrences all number
    2
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    Depression
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    Insomnia
         subjects affected / exposed
    3 / 64 (4.69%)
    4 / 58 (6.90%)
         occurrences all number
    3
    4
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    54 / 64 (84.38%)
    42 / 58 (72.41%)
         occurrences all number
    54
    42
    Aspartate aminotransferase increased
         subjects affected / exposed
    52 / 64 (81.25%)
    39 / 58 (67.24%)
         occurrences all number
    52
    39
    Bilirubin increased
         subjects affected / exposed
    19 / 64 (29.69%)
    14 / 58 (24.14%)
         occurrences all number
    19
    14
    Creatinine increased
         subjects affected / exposed
    5 / 64 (7.81%)
    2 / 58 (3.45%)
         occurrences all number
    5
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    22 / 64 (34.38%)
    15 / 58 (25.86%)
         occurrences all number
    22
    15
    Hemoglobin increased
         subjects affected / exposed
    3 / 64 (4.69%)
    5 / 58 (8.62%)
         occurrences all number
    3
    5
    Neutrophil count decreased
         subjects affected / exposed
    45 / 64 (70.31%)
    36 / 58 (62.07%)
         occurrences all number
    45
    36
    Lymphocyte count decreased
         subjects affected / exposed
    19 / 64 (29.69%)
    5 / 58 (8.62%)
         occurrences all number
    19
    5
    Polynuclear neutrophils increased
         subjects affected / exposed
    54 / 64 (84.38%)
    47 / 58 (81.03%)
         occurrences all number
    54
    47
    Weight loss
         subjects affected / exposed
    9 / 64 (14.06%)
    9 / 58 (15.52%)
         occurrences all number
    9
    9
    Platelet count decreased
         subjects affected / exposed
    43 / 64 (67.19%)
    38 / 58 (65.52%)
         occurrences all number
    43
    38
    Hypoalbuminaemia
         subjects affected / exposed
    15 / 64 (23.44%)
    8 / 58 (13.79%)
         occurrences all number
    15
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 64 (6.25%)
    7 / 58 (12.07%)
         occurrences all number
    4
    7
    Dysgeusia
         subjects affected / exposed
    5 / 64 (7.81%)
    5 / 58 (8.62%)
         occurrences all number
    5
    5
    Paresthesia
         subjects affected / exposed
    22 / 64 (34.38%)
    23 / 58 (39.66%)
         occurrences all number
    22
    23
    Neuropathy peripheral
         subjects affected / exposed
    15 / 64 (23.44%)
    16 / 58 (27.59%)
         occurrences all number
    15
    16
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    58 / 64 (90.63%)
    55 / 58 (94.83%)
         occurrences all number
    58
    55
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    5 / 64 (7.81%)
    1 / 58 (1.72%)
         occurrences all number
    5
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    15 / 64 (23.44%)
    18 / 58 (31.03%)
         occurrences all number
    15
    18
    Diarrhoea
         subjects affected / exposed
    45 / 64 (70.31%)
    35 / 58 (60.34%)
         occurrences all number
    45
    35
    Stomach pain
         subjects affected / exposed
    6 / 64 (9.38%)
    2 / 58 (3.45%)
         occurrences all number
    6
    2
    Abdominal pain
         subjects affected / exposed
    24 / 64 (37.50%)
    15 / 58 (25.86%)
         occurrences all number
    24
    15
    Mucitis
         subjects affected / exposed
    14 / 64 (21.88%)
    12 / 58 (20.69%)
         occurrences all number
    14
    12
    Nausea
         subjects affected / exposed
    42 / 64 (65.63%)
    30 / 58 (51.72%)
         occurrences all number
    42
    30
    Vomiting
         subjects affected / exposed
    30 / 64 (46.88%)
    21 / 58 (36.21%)
         occurrences all number
    30
    21
    Oral mucositis
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    31 / 64 (48.44%)
    32 / 58 (55.17%)
         occurrences all number
    31
    32
    Hyperhidrosis
         subjects affected / exposed
    0 / 64 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    3
    Skin dryness
         subjects affected / exposed
    4 / 64 (6.25%)
    3 / 58 (5.17%)
         occurrences all number
    4
    3
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    8 / 64 (12.50%)
    3 / 58 (5.17%)
         occurrences all number
    8
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 64 (7.81%)
    3 / 58 (5.17%)
         occurrences all number
    5
    3
    Myalgia
         subjects affected / exposed
    6 / 64 (9.38%)
    6 / 58 (10.34%)
         occurrences all number
    6
    6
    Infections and infestations
    Bronchial infection
         subjects affected / exposed
    1 / 64 (1.56%)
    9 / 58 (15.52%)
         occurrences all number
    1
    9
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    38 / 64 (59.38%)
    26 / 58 (44.83%)
         occurrences all number
    38
    26
    Hyperglycaemia
         subjects affected / exposed
    4 / 64 (6.25%)
    3 / 58 (5.17%)
         occurrences all number
    4
    3
    Hyperkalaemia
         subjects affected / exposed
    14 / 64 (21.88%)
    4 / 58 (6.90%)
         occurrences all number
    14
    4
    Hypocalcaemia
         subjects affected / exposed
    9 / 64 (14.06%)
    4 / 58 (6.90%)
         occurrences all number
    9
    4
    Hypokalaemia
         subjects affected / exposed
    9 / 64 (14.06%)
    4 / 58 (6.90%)
         occurrences all number
    9
    4
    Hyponatraemia
         subjects affected / exposed
    15 / 64 (23.44%)
    8 / 58 (13.79%)
         occurrences all number
    15
    8

    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/32623182
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