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    Clinical Trial Results:
    Phase II Randomized Study Measuring the Interest of Pursuing or Not the chemotherapy for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidin/Pt Salt chemotherapy

    Summary
    EudraCT number
    		 2017-003660-13
    Trial protocol
    		 FR  
    Global end of trial date
    16 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E-DIS-2-1705
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03301454
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Oscar Lambret
    Sponsor organisation address
    3 rue Frédéric Combemale – BP307 , LILLE, France, 59020
    Public contact
    Sponsor unit, Centre Oscar Lambret, +33 320295918, promotion@o-lambret.fr
    Scientific contact
    Sponsor unit, Centre Oscar Lambret, +33 320295918, promotion@o-lambret.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
    16 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Estimate the overall survival for patients suffering from non-progressive Esophageal cancer at and after 6 weeks of treatment until progression
    Protection of trial subjects
    This study will be conducted in accordance with the ethical principles of the 1964 Helsinki declaration, revised in 2013 in Fortaleza, with the rules of Good Clinical Practice (GCP) defined by the International Conference on Harmonization (ICH-E6, 17/7/96). The clinical trial may not begin before approval of the Ethics Committees and authorization by competent authorities concerned is obtained
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Aug 2018
    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: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    3
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of the 15 patients recruited in the study, 9 were randomized between 01/10/2018 and 27/01/2022 The study ended prematurely due to very low accrual.

    Pre-assignment
    Screening details
    		 Of the 15 patients included, 9 were randomised between 01/10/2018 and 27/01/2022

    Period 1
    Period 1 title
    Randomised trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Patients included in the randomised trial after 6 cycles of LV5FU2-paclitaxel (N=9)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A - Continuation of chemotherapy
    Arm description
    		 Continuation of chemotherapy until progression + improved supportive care 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - continuous 5-FU over 46h: 3000 mg/m², calcium folinate 400 mg/m² or calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² Day 1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    LV5FU2 + paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Injection
    Dosage and administration details
    Continuation of chemotherapy until progression + improved supportive care 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - continuous 5-FU over 46h: 3000 mg/m², calcium folinate 400 mg/m² or calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² Day 1)

    Arm title
    		 Arm B - Treatment discontinuation
    Arm description
    		 Interruption of chemotherapy + improved supportive care.
    Arm type
    		 Supportive care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Arm A - Continuation of chemotherapy Arm B - Treatment discontinuation
    Started
    4
    5
    Completed
    4
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A - Continuation of chemotherapy
    Reporting group description
    		 Continuation of chemotherapy until progression + improved supportive care 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - continuous 5-FU over 46h: 3000 mg/m², calcium folinate 400 mg/m² or calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² Day 1)

    Reporting group title
    Arm B - Treatment discontinuation
    Reporting group description
    		 Interruption of chemotherapy + improved supportive care.

    Reporting group values
    		 Arm A - Continuation of chemotherapy Arm B - Treatment discontinuation Total
    Number of subjects
    		 4 5 9
    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)
    		 2 1 3
        From 65-84 years
    		 2 4 6
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66.5 (60 to 81) 71 (56 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 0 3 3
        Male
    		 4 2 6
    Histology
    Squamous cell carcinoma of the esophagus
    Units: Subjects
        Squamous cell carcinoma of the esophagus
    		 4 5 9
    Type of metastases
    Type of metastases
    Units: Subjects
        Synchronous
    		 2 2 4
        Metachronous
    		 2 2 4
        Missing data
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Arm A - Continuation of chemotherapy
    Reporting group description
    		 Continuation of chemotherapy until progression + improved supportive care 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - continuous 5-FU over 46h: 3000 mg/m², calcium folinate 400 mg/m² or calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² Day 1)

    Reporting group title
    Arm B - Treatment discontinuation
    Reporting group description
    		 Interruption of chemotherapy + improved supportive care.

    Primary: Overall Survival (not evaluated)

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    End point title
    		 Overall Survival (not evaluated) [1]
    End point description
    The overall survival was not estimated because only 9 patients were recruited in the randomized trial
    End point type
    Primary
    End point timeframe
    The overall survival was not estimated because only 9 patients were recruited in the randomized trial
    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: No statistical analyses for this end point. The overall survival was not estimated because only 9 patients were recruited in the randomized trial
    End point values
    		 Arm A - Continuation of chemotherapy Arm B - Treatment discontinuation
    Number of subjects analysed
    4
    5
    Units: Not applicable
    4
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    A total of 5 events were reported to the pharmaco-vigilance unit including 5 Serious Adverse Events
    Adverse event reporting additional description
    - 2 SAE in initial phase of treatment (chest pain, cardiac decompensation) - 2 SAE after randomisation -1 in arm A (left inguino-scrotal hernia) -1 in arm B (hypokalemia) - 1 case of special situation (administration error with associated adverse event)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Arm A - Continuation of chemotherapy
    Reporting group description
    		 Arm A - Continuation of chemotherapy

    Reporting group title
    Arm B - Treatment discontinuation
    Reporting group description
    		 Arm B - Treatment discontinuation

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only SAEs were recorded because the study was terminated prematurely.
    Serious adverse events
    		 Arm A - Continuation of chemotherapy Arm B - Treatment discontinuation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 5 (20.00%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Calcium levofolinate overdose
    Additional description: CALCIUM LEVOFOLINATE OVERDOSE
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 5 (20.00%)
         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: 0%
    Non-serious adverse events
    		 Arm A - Continuation of chemotherapy Arm B - Treatment discontinuation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 5 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Oct 2018
    - Updated List of centres, -Calcium levolinate dose correction, -modification of study treatment discontinuation criteria, -Updated Subject information sheet, informed consent form -Compliance GDPR
    31 Oct 2019
    - Inclusion criteria modification : testing for DPD deficiency - cardiac monitoring added - Calcium levolinate dose correction, - update study schedule
    02 Oct 2020
    - Updated List of centres - Updated study scheme - clarification of adverse event not to be reported to PV
    20 Apr 2021
    - Updated List of centres, - Updated study scheme - Updated Paclitaxel SPC with impact on protocol
    29 Jul 2021
    - Updated List of centres
    07 Jan 2022
    - Updated List of centres
    09 Mar 2022
    - Updated Fluorouracile SPC with impact on protocol

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Jun 2023
    The study was stopped prematurely due to a lack of recruitment. Indeed, after more than 3 years of recruitment, only 15 patients had been included, and 9 were randomized. As a result, this study will unfortunately not be able to be scientifically exploited.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was stopped prematurely due to a lack of recruitment.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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