Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Etude de phase II randomisée chez des patients porteurs d’un cancer épidermoïde métastatique de l’œsophage évaluant l’intérêt de la poursuite ou non d’un traitement cytotoxique chez des patients non progressifs après 6 semaines de chimiothérapie

    Summary
    EudraCT number
    		 2010-021439-16
    Trial protocol
    		 FR  
    Global end of trial date
    12 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    E-DIS-1006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01248299
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Oscar Lambret
    Sponsor organisation address
    3 Rue Frédéric Combemale, Lille, France, 59000
    Public contact
    Marie VANSEYMORTIER, Centre Oscar Lambret, 33 320295918, promotion@o-lambret.fr
    Scientific contact
    Antoine Adenis, Centre Oscar Lambret, 33 467612442, antoine.Adenis@icm.unicancer.f
    Sponsor organisation name
    Centre Oscar Lambret
    Sponsor organisation address
    3 Rue Frédéric Combemale, Lille, France, 59000
    Public contact
    Marie VANSEYMORTIER, Centre Oscar Lambret, 33 320295918, promotion@o-lambret.fr
    Scientific contact
    Antoine ADENIS, Centre Oscar Lambret, 33 467612442, Antoine.Adenis@icm.unicancer.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
    12 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate overall survival
    Protection of trial subjects
    This clinical trial will be conducted in accordance with the protocol, the ethical principles laid down by the 18th World Medical Assembly (Helsinki, 1964) and all applicable amendments laid down by the World Medical Assemblies, the International Conference on Harmonization (ICH) consolidated Guideline E6 for Good Clinical Practice (CPMP/ICH/135/95), and all applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jan 2011
    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: 105
    Worldwide total number of subjects
    105
    EEA total number of subjects
    105
    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)
    61
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 105 patients were included in the initial part between 03/01/2011 and 09/02/2015 in 13 french centers. 67 patients were randomised between 07/03/2011 and 24/03/2015: 34 in arm A (continue CT) and 33 in arm B (stop CT).

    Pre-assignment
    Screening details
    		 A total of 106 patients are needed to allow the randomisation of 31 patients in each treatment arm.

    Period 1
    Period 1 title
    Initial phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Initial part
    Arm description
    		 Study chemotherapy during the initial part was at the choice of the investigator: FU-CDDP (2 cures expected), or LV5FU2-CDDP (3 cures expected), or FOLFOX (3 cures expected), or TFP 4b (2 cures expected). During the initial part, chemotherapy lasts 6 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Investigational medicinal product name
    Calcium Levofolinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Investigational medicinal product name
    Fluoro-uracile
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Number of subjects in period 1
    		Initial part
    Started
    105
    Completed
    101
    Not completed
    4
         Protocol deviation
    4
    Period 2
    Period 2 title
    Randomisation phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-CONT
    Arm description
    		 Patients randomised in this CT-CONT arm continue the same chemotherapy as the chemotherapy receiveid in the initial arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Investigational medicinal product name
    Calcium Levofolinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Investigational medicinal product name
    Fluoro-uracile
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Protocole FU-CDDP J1 à J5 Fluoro-uracile 800 mg/m² J1 ou J2 CisPlatine 75 mg/m² Tous les 21 jours Protocole LV5FU2-CDDP J1 et J2 Elvorine 200 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J2 CisPlatine 50 mg/m² Tous les 14 jours Protocole FOLFOX J1 Oxaliplatine 85 mg/m² sur 2h J1 et J2 Fluoro-uracile 400 mg/m² bolus J1 et J2 Fluoro-uracile 600 mg/m² continu sur 22h J1 et J2 Elvorine 500 mg/m² Tous les 14 jours Protocole TPF J1 et J8 Docetaxel 30 mg/m² J1 CisPlatine 60 mg/m² En continu Fluoro-uracile 200 mg/m² /j Tous les 21 jours Ou J1 Docetaxel 50 mg/m² J1 CisPlatine 70 mg/m² J1 à J5 Fluoro-uracile 700 mg/m² /j

    Arm title
    		 CT-DISC
    Arm description
    		 Patients randomised in this CT-DISC arm did not received any treatment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Not randomised
    Arm description
    		 Some patients were not randomised due to progression during the initial part of the study
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		CT-CONT CT-DISC Not randomised
    Started
    34
    33
    34
    Completed
    34
    33
    34

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Initial part
    Reporting group description
    		 Study chemotherapy during the initial part was at the choice of the investigator: FU-CDDP (2 cures expected), or LV5FU2-CDDP (3 cures expected), or FOLFOX (3 cures expected), or TFP 4b (2 cures expected). During the initial part, chemotherapy lasts 6 weeks

    Reporting group values
    		 Initial part Total
    Number of subjects
    		 105 105
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (43 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 89 89

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Initial part
    Reporting group description
    		 Study chemotherapy during the initial part was at the choice of the investigator: FU-CDDP (2 cures expected), or LV5FU2-CDDP (3 cures expected), or FOLFOX (3 cures expected), or TFP 4b (2 cures expected). During the initial part, chemotherapy lasts 6 weeks
    Reporting group title
    CT-CONT
    Reporting group description
    		 Patients randomised in this CT-CONT arm continue the same chemotherapy as the chemotherapy receiveid in the initial arm

    Reporting group title
    CT-DISC
    Reporting group description
    		 Patients randomised in this CT-DISC arm did not received any treatment

    Reporting group title
    Not randomised
    Reporting group description
    		 Some patients were not randomised due to progression during the initial part of the study

    Subject analysis set title
    ITT randomised
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised are analyzed (67 patients: 34 in CT-CONT arm and 33 patient in CT-DISC arm)

    Primary: Overall survival

    		 Close Top of page
    End point title
    		 Overall survival
    End point description
    End point type
    Primary
    End point timeframe
    median overall survival in months
    End point values
    		 CT-CONT CT-DISC ITT randomised
    Number of subjects analysed
    34
    33
    67
    Units: months
        number (confidence interval 95%)
    8.5 (6.6 to 12)
    8.8 (5.9 to 13.4)
    8.5 (6.2 to 9.9)
    Statistical analysis title
    		 Overall survival randomised part
    Statistical analysis description
    No treatment arm comparison was planned
    Comparison groups
    CT-CONT v CT-DISC
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 o treatment arm comparison was planned
    Parameter type
    		 No treatment arm comparison was planned
    Confidence interval

    Secondary: Progression-free survival

    		 Close Top of page
    End point title
    		 Progression-free survival
    End point description
    End point type
    Secondary
    End point timeframe
    median progression-free survival
    End point values
    		 CT-CONT CT-DISC ITT randomised
    Number of subjects analysed
    34
    33
    67
    Units: months
        number (confidence interval 95%)
    4 (2.8 to 5.8)
    1.4 (1.4 to 2.7)
    3 (2.7 to 4.1)
    No statistical analyses for this end point

    Secondary: Quality of life

    		 Close Top of page
    End point title
    		 Quality of life
    End point description
    For functional scales, QLQ-C30 and QLQ-OES18 scores were considered as a definitive deterioration if the score decreased by more than 10 points compared with the score at randomisation and without later improvement superior to 10 points compared with the baseline. For symptom scales, a definitive deterioration was defined as an increase of 10 points or more without subsequent decrease. For each dimension of the QoL questionnaires, the time until definitive deterioration (TUDD) was defined as the time from randomisation to the first observation of a definitive deterioration of the corresponding score or death. Patients alive without reported definitive deterioration were censored at the date of the last follow-up visit. Patients without any QoL questionnaires were censored at randomisation. TUDD was estimated using the Kaplan Meier method. The impact of treatments on the different dimensions of the QoL was estimated by hazard ratios of QoL deterioration using Cox models.
    End point type
    Secondary
    End point timeframe
    QoL was assessed using the EORTC quality of life score questionnaire (QLQ-C30) and with the oesophagus-specific questionnaire (QLQ-OES18) at the baseline and every 6 weeks thereafter until 42 weeks after randomisation.
    End point values
    		 CT-CONT CT-DISC
    Number of subjects analysed
    34
    33
    Units: median
    number (confidence interval 95%)
        QLQ-C30 Physical
    7.3 (5.6 to 9.4)
    5.4 (2.9 to 8.5)
        QLQ-C30 Global health status
    6.6 (3.3 to 12.4)
    4.2 (2.9 to 8.5)
        QLQ-C30 Role
    5.6 (3.1 to 8.1)
    4.5 (3.2 to 8.3)
        QLQ-C30 Emotional
    7.1 (4.2 to 11.9)
    5.6 (3.2 to 7.8)
        QLQ-C30 Cognitive
    7.8 (3.3 to 12)
    4.1 (2.8 to 8.5)
        QLQ-C30 Social
    5.6 (3.0 to 8.1)
    6.2 (4.2 to 8.8)
        QLQ-C30 Fatigue
    5.6 (2.8 to 9.6)
    4.4 (2.9 to 6.4)
        QLQ-C30 Nausea
    7.8 (3.3 to 9.8)
    5.4 (2.0 to 7.8)
        QLQ-C30 Pain
    5.6 (2.8 to 7.0)
    2.9 (2.1 to 6.3)
        QLQ-C30 Dyspnoea
    7.3 (4.2 to 11.9)
    4.4 (2.8 to 7.8)
        QLQ-C30 Insomnia
    7.3 (3.3 to 11.9)
    5.4 (2.0 to 7.8)
        QLQ-C30 Appetite loss
    7.1 (5.2 to 12)
    4.5 (2.9 to 7.8)
        QLQ-C30 Constipation
    7.3 (5.2 to 11.9)
    5.7 (2.8 to 9.9)
        QLQ-C30 Diarrhoea
    6.6 (3.3 to 9.9)
    4.5 (2.9 to 8.5)
        QLQ-C30 Financial difficulties
    8.1 (5.6 to 12.4)
    6.3 (3.2 to 9.9)
        QLQ-C30 Pain alone
    5.6 (3.0 to 7.3)
    5.4 (2.8 to 8.3)
        QLQ-OES18 Dysphagia
    7.3 (4.2 to 12)
    2.9 (1.4 to 4.4)
        QLQ-OES18 Eating
    7.7 (5.6 to 9.5)
    2.9 (2.0 to 5.9)
        QLQ-OES18 Reflux
    7.8 (4.7 to 11.9)
    3.2 (1.4 to 7.8)
        QLQ-OES18 Pain
    8.1 (5.6 to 12.0)
    2.4 (1.4 to 3.2)
        QLQ-OES18 Trouble swallowing
    7.8 (5.2 to 11.9)
    6.3 (3.2 to 9.1)
        QLQ-OES18 Choked when swallowing
    7.1 (4.2 to 9.9)
    5.4 (3.0 to 6.9)
        QLQ-OES18 Dry mouth
    6.8 (3.3 to 9.8)
    5.9 (3.1 to 9.9)
        QLQ-OES18 Taste
    7.3 (5.2 to 9.5)
    4.4 (2.9 to 7.8)
        QLQ-OES18 Coughing
    8.1 (5.6 to 9.9)
    6.3 (3.2 to 8.8)
    Statistical analysis title
    		 TUDD Global health status
    Statistical analysis description
    TUDD was estimated using the KaplaneMeier method. The impact of treatments on the different dimensions of the QoL was estimated by hazard ratios (HRCT-DISC/CTCONT of QoL deterioration using Cox models.
    Comparison groups
    CT-CONT v CT-DISC
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 2.53

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Patients were observed until death or until 48 months after study entry.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2
    Reporting groups
    Reporting group title
    All adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 All adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 64 (29.69%)
         number of deaths (all causes)
    54
         number of deaths resulting from adverse events
    1
    Investigations
    WEIGHT DECREASED
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    SHOCK
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    HEPATIC ENCEPHALOPATHY
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    ALTERED STATE OF CONSCIOUSNESS
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    EPILEPSY
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PYREXIA
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    ANAL FISSURE
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    DYSPHAGIA
         subjects affected / exposed
    7 / 64 (10.94%)
         occurrences causally related to treatment / all
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    PANCREATITIS
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    LUNG DISORDER
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    DIVERTICULITIS
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INFECTION
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 64 (76.56%)
    Nervous system disorders
    PARAESTHESIA
         subjects affected / exposed
    20 / 64 (31.25%)
         occurrences all number
    65
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    8 / 64 (12.50%)
         occurrences all number
    22
    NEUTROPENIA
         subjects affected / exposed
    12 / 64 (18.75%)
         occurrences all number
    24
    LYMPHOPENIA
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    8
    Thrombocytopenia
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    15
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    17 / 64 (26.56%)
         occurrences all number
    39
    FATIGUE
         subjects affected / exposed
    10 / 64 (15.63%)
         occurrences all number
    20
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    7 / 64 (10.94%)
         occurrences all number
    9
    DYSPHAGIA
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    9
    MUCOSAL INFLAMMATION
         subjects affected / exposed
    8 / 64 (12.50%)
         occurrences all number
    8
    NAUSEA
         subjects affected / exposed
    8 / 64 (12.50%)
         occurrences all number
    15
    VOMITING
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    7
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    8 / 64 (12.50%)
         occurrences all number
    8
    Weight decreased
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    7

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Nov 2010
    Addition of investigators
    07 Feb 2011
    Addition of an investigator and addition of trial site
    07 Jul 2011
    Addition of a center
    08 Aug 2011
    Addition of an investigator
    17 Oct 2011
    Protocol amendement (pharmaco-vigilance and update of the investigator list)
    03 Jun 2013
    Addition of a center Modification of study duration and number of patients Addition of investigators
    31 Jul 2013
    Addition of a center

    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/30798084
    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.

    European Medicines Agency © 1995-Sat May 04 22:57:47 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA