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    Clinical Trial Results:
    Phase III Multicenter Randomized Study Comparing the Effect of a 6-month Adjuvant Chemotherapy With Gemcitabine-Oxaliplatin to Observation in Patients Who Underwent Surgery for Biliary Tract Cancers

    Summary
    EudraCT number
    		 2008-004560-39
    Trial protocol
    		 FR  
    Global end of trial date
    20 Feb 2019

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ACCORD 18/0803
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01313377
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Unicancer
    Sponsor organisation address
    101 rue de Tolbiac, Paris, France, 75013
    Public contact
    Nourredine AIT-RAHMOUNE, Unicancer, 33 1 71 93 67 04, n.ait-rahmoune@unicancer.fr
    Scientific contact
    Nourredine AIT-RAHMOUNE, Unicancer, 33 1 71 93 67 04, n.ait-rahmoune@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
    30 Jun 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the Prodige 12 – Accord 18 study were: - To evaluate the effect of Gemcitabine – Oxaliplatin adjuvant chemotherapy (GEMOX) on Relapse-Free Survival (RFS) in resected Biliary Tract Cancer (BTC) patients compare to clinical observation. - To compare Quality Of Life (QoL) in GEMOX-treated resected BTC patients versus clinical observation. This trial considered RFS as the primary endpoint (the calculation of the number of subjects required and the design of the study are based on this endpoint) and the quality of life as the secondary primary endpoint (power calculation). This is not a composite criterion integrating recurrence and QoL. There are therefore two independently analyzed endpoints.
    Protection of trial subjects
    In order to ensure the protection of the rights, safety and well-being of trial subjects, this clinical trial was conducted in accordance with the Declaration of Helsinki (1964) and subsequent amendments, ICH Good Clinical Practice Guidelines (CPMP/ICH/135/95), the European Directive (2001/20/CE) and the applicable local regulatory requirements and laws. Furthermore, an independent Ethics Committees reviewed and gave a favorable opinion to the study documents, including the initial protocol and all subsequent amendments, and all information and documents provided to subjects/patients.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Sep 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 194
    Worldwide total number of subjects
    194
    EEA total number of subjects
    194
    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)
    115
    From 65 to 84 years
    79
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Prodige 12 – Accord 18 was a randomized phase III, double arm, multicenter trial designed to compare the effect of the adjuvant chemotherapy of Gemcitabine-Oxaliplatin for 6 months versus observation on Relapse Free Survival and Quality of life in treating non-metastatic patients who underwent surgery for Biliary Tract Cancers.

    Pre-assignment
    Screening details
    		 The trial consisted of a screening phase before randomization to establish eligibility, a treatment phase (14-day treatment cycles; 12 cycles), and a long-term follow-up to monitor relapse-free survival, quality of life, disease-free survival, overall survival, and safety.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GEMOX
    Arm description
    		 The GEMOX regimen consisted by the administration of Gemcitabine Hydrochloride and Oxaliplatin in cycle of two days: - Gemcitabine Hydrochloride was administered at the dose of 1000mg/m2 intravenously in 500 mL NaCl 0.9% over 100 minutes (fixed-dose infusion rate, 10 mg/m2/min) on Day 1 (D1). - Oxaliplatin was administered at the dose of 85 mg/m2 intravenously in 500 mL glucose 5% over 2 hours on D2. GEMOX was administrated every 14 days for 12 cycles to the patients who met all inclusion criteria, none of the exclusion criteria and were randomized in arm A
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000mg/m2 intravenously in 500 mL NaCl 0.9% over 100 minutes (fixed-dose infusion rate, 10 mg/m2/min) on day 1.

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m2 intravenously in 500 mL glucose 5% over 2 hours on day 2. In order to prevent oxaliplatin neurotoxicity, 15-minute infusion with 100 ml of 5% glucose each containing 10 ml of 10% calcium gluconate and 10 ml of 15% magnesium sulfate were required before and after each oxaliplatin infusion.

    Arm title
    		 Observation
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		GEMOX Observation
    Started
    95
    99
    Completed
    32
    41
    Not completed
    63
    58
         Received <50% of dose during the first 6 cycles
    11
    -
         Did not meet inclusion criteria
    11
    17
         Death
    41
    41

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GEMOX
    Reporting group description
    		 The GEMOX regimen consisted by the administration of Gemcitabine Hydrochloride and Oxaliplatin in cycle of two days: - Gemcitabine Hydrochloride was administered at the dose of 1000mg/m2 intravenously in 500 mL NaCl 0.9% over 100 minutes (fixed-dose infusion rate, 10 mg/m2/min) on Day 1 (D1). - Oxaliplatin was administered at the dose of 85 mg/m2 intravenously in 500 mL glucose 5% over 2 hours on D2. GEMOX was administrated every 14 days for 12 cycles to the patients who met all inclusion criteria, none of the exclusion criteria and were randomized in arm A

    Reporting group title
    Observation
    Reporting group description
    		 -

    Reporting group values
    		 GEMOX Observation Total
    Number of subjects
    		 95 99 194
    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)
    		 55 60 115
        From 65-84 years
    		 40 39 79
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 63 (33 to 83) 63 (40 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 38 49 87
        Male
    		 57 50 107
    Tumor localization
    Units: Subjects
        Gallbladder
    		 19 23 42
        Extrahepatic
    		 30 28 58
        Intrahepatic
    		 46 45 91
        Unknown
    		 0 3 3

    End points

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    End points reporting groups
    Reporting group title
    GEMOX
    Reporting group description
    		 The GEMOX regimen consisted by the administration of Gemcitabine Hydrochloride and Oxaliplatin in cycle of two days: - Gemcitabine Hydrochloride was administered at the dose of 1000mg/m2 intravenously in 500 mL NaCl 0.9% over 100 minutes (fixed-dose infusion rate, 10 mg/m2/min) on Day 1 (D1). - Oxaliplatin was administered at the dose of 85 mg/m2 intravenously in 500 mL glucose 5% over 2 hours on D2. GEMOX was administrated every 14 days for 12 cycles to the patients who met all inclusion criteria, none of the exclusion criteria and were randomized in arm A

    Reporting group title
    Observation
    Reporting group description
    		 -

    Primary: Relapse-Free Survival

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    End point title
    		 Relapse-Free Survival
    End point description
    End point type
    Primary
    End point timeframe
    Relapse-free Survival was evaluated between randomisation to the date of relapse, apparition of a second Biliary tract cancers or death from any cause every 3 months for 2 years then every 6 months for the following 3 years until (up to 5.5 years)
    End point values
    		 GEMOX Observation
    Number of subjects analysed
    95
    99
    Units: months
        median (confidence interval 95%)
    30.4 (15.4 to 43.0)
    18.5 (12.6 to 38.2)
    Statistical analysis title
    		 Relapse-free survival
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4724
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.18

    Primary: Time to global health deterioration

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    End point title
    		 Time to global health deterioration
    End point description
    End point type
    Primary
    End point timeframe
    Time to deterioration was evaluated at Baseline (randomisation), every 3 months for 2 years then every 6 months for the following 3 years.
    End point values
    		 GEMOX Observation
    Number of subjects analysed
    95
    99
    Units: percent
    number (not applicable)
        Deterioration
    26
    23
        No deterioration
    60
    72
        NA
    9
    4
    Statistical analysis title
    		 Time to deterioration
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3899
    Method
    		 Logrank
    Confidence interval

    Secondary: overall survival

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    End point title
    		 overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization to death (up to 5.5 years)
    End point values
    		 GEMOX Observation
    Number of subjects analysed
    95
    99
    Units: month
        median (confidence interval 95%)
    75.8 (34.4 to 78)
    50.8 (38.0 to 78)
    Statistical analysis title
    		 Overall survival
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7352
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.86

    Secondary: Disease-free survival

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    End point title
    		 Disease-free survival
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization to disease progression or death (up to 5.5 years)
    End point values
    		 GEMOX Observation
    Number of subjects analysed
    95
    99
    Units: month
        median (confidence interval 95%)
    30.4 (15.4 to 43.3)
    18.5 (12.6 to 38.2)
    Statistical analysis title
    		 Disease-free survival
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.466
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.25

    Secondary: Relapse-free survival (prognostic N stage)

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    End point title
    		 Relapse-free survival (prognostic N stage)
    End point description
    End point type
    Secondary
    End point timeframe
    up to 5.5 years
    End point values
    		 GEMOX Observation
    Number of subjects analysed
    95 [1]
    99 [2]
    Units: month
    median (confidence interval 95%)
        N0
    48.8 (17.8 to 78)
    47.6 (29.3 to 78)
        N+
    16.3 (9.4 to 34.9)
    12.4 (6.2 to 16.2)
        NX
    45.8 (2.6 to 54.3)
    11.2 (2.6 to 48.5)
    Notes
    [1] - N0 (35), N+ (35), NX (11)
    [2] - N0 (48), (N+ (36), NX (15)
    Statistical analysis title
    		 RFS N0
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.79
    Statistical analysis title
    		 RFS N+
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4105
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.35
    Statistical analysis title
    		 RFS NX
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1387
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 1.33

    Secondary: Relapse-free survival (prognostic resection)

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    End point title
    		 Relapse-free survival (prognostic resection)
    End point description
    End point type
    Secondary
    End point timeframe
    up to 5.5 years
    End point values
    		 GEMOX Observation
    Number of subjects analysed
    95 [3]
    99 [4]
    Units: month
    median (confidence interval 95%)
        R0
    36.2 (21.0 to 48.8)
    22.8 (12.6 to 44.3)
        R1
    12.3 (8.5 to 17.8)
    14.3 (5.1 to 21.6)
    Notes
    [3] - R0 (82), R1 (13)
    [4] - R0 (87), R1 (12)
    Statistical analysis title
    		 RFS R0
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5183
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.3
    Statistical analysis title
    		 RFS R1
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6772
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.97

    Secondary: Relapse-free survival (prognostic primary tumor location)

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    End point title
    		 Relapse-free survival (prognostic primary tumor location)
    End point description
    End point type
    Secondary
    End point timeframe
    up to 5.5 years
    End point values
    		 GEMOX Observation
    Number of subjects analysed
    95 [5]
    99 [6]
    Units: month
    median (confidence interval 95%)
        Intrahepatic
    30.4 (12.9 to 45.8)
    12.6 (8.3 to 38.2)
        Extrahepatic
    38.7 (21.0 to 75)
    15.9 (12.3 to 32.9)
        Gallbladder
    11.5 (6.0 to 60)
    62 (11.5 to 78)
    Notes
    [5] - Intrahepatic (41), extrahepatic (37), gallbladder (17)
    [6] - Intrahepatic (45), extrahepatic (33), gallbladder (21)
    Statistical analysis title
    		 RFS intrahepatic
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2004
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.2
    Statistical analysis title
    		 RFS extrahepatic
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0854
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 1.08
    Statistical analysis title
    		 RFS gallbladder
    Comparison groups
    GEMOX v Observation
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0345
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    2.559
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 6.32

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall period of the study (up to 5.5 years after randomization)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    GEMOX
    Reporting group description
    		 The GEMOX regimen consisted by the administration of Gemcitabine Hydrochloride and Oxaliplatin in cycle of two days: - Gemcitabine Hydrochloride was administered at the dose of 1000mg/m2 intravenously in 500 mL NaCl 0.9% over 100 minutes (fixed-dose infusion rate, 10 mg/m2/min) on Day 1 (D1). - Oxaliplatin was administered at the dose of 85 mg/m2 intravenously in 500 mL glucose 5% over 2 hours on D2. GEMOX was administrated every 14 days for 12 cycles to the patients who met all inclusion criteria, none of the exclusion criteria and were randomized in arm A.

    Reporting group title
    Observation
    Reporting group description
    		 -

    Serious adverse events
    		 GEMOX Observation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 95 (23.16%)
    13 / 99 (13.13%)
         number of deaths (all causes)
    41
    41
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Chronic myeloid leukaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peptic ulcer haemorrhage
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 99 (1.01%)
         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
    fever
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumopathy
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress syndrome adult
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Biopsy liver
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 95 (0.00%)
    2 / 99 (2.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction acute
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (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
    Neurotoxicity NOS
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (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
    Febrile neutropenia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (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
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary anastomosis stenosis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis intrahepatic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Biliary sepsis
    alternative dictionary used: MedDRA 16
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (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
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis infective
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthesis related infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septicemia due to Escherichia coli (E. coli)
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septicaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 99 (1.01%)
         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
    		 GEMOX Observation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    93 / 95 (97.89%)
    64 / 99 (64.65%)
    Cardiac disorders
    Oedema
         subjects affected / exposed
    5 / 95 (5.26%)
    1 / 99 (1.01%)
         occurrences all number
    7
    1
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    76 / 95 (80.00%)
    5 / 99 (5.05%)
         occurrences all number
    136
    8
    Taste alteration
         subjects affected / exposed
    12 / 95 (12.63%)
    0 / 99 (0.00%)
         occurrences all number
    15
    0
    Headache
         subjects affected / exposed
    12 / 95 (12.63%)
    2 / 99 (2.02%)
         occurrences all number
    17
    3
    Blood and lymphatic system disorders
    Haemoglobin
         subjects affected / exposed
    76 / 95 (80.00%)
    24 / 99 (24.24%)
         occurrences all number
    128
    41
    Neutrophil count
         subjects affected / exposed
    67 / 95 (70.53%)
    6 / 99 (6.06%)
         occurrences all number
    96
    15
    Platelet count
         subjects affected / exposed
    87 / 95 (91.58%)
    24 / 99 (24.24%)
         occurrences all number
    136
    41
    Leukocyte
         subjects affected / exposed
    44 / 95 (46.32%)
    9 / 99 (9.09%)
         occurrences all number
    63
    17
    Infections and infestations
    Infection
         subjects affected / exposed
    14 / 95 (14.74%)
    4 / 99 (4.04%)
         occurrences all number
    18
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Dec 2009
    In the first version of the protocol, the platelets values for dose adjustment in the event of hematological or non-hematological toxicities (neuropathy excluded) during intercure was 10 000 ≤ Plaquettes < 75 000/mm3. It was then modified to 25 000 000 ≤ Platelets < 75 000/mm3.
    03 Mar 2011
    Coagulation was added to the list of biological exams at baseline.
    06 May 2011
    To adapt to a recurring clinical situation where patients had a delay in treatment administration due to a grade 2 adverse event even though they presented no symptoms, the treatment was permanently discontinuted if the postponement of treatment was greater than 28 days (6 weeks) rather than 21 days (5 weeks).

    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.
    When the trial was designed in 2009, gemcitabine-oxaliplatin combination was considered a valuable regimen for advanced disease. Nowadays, the reference first-line regimen in the advanced setting gemcitabine-cisplatin combination.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30707660
    http://www.ncbi.nlm.nih.gov/pubmed/35182925
    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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