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    Clinical Trial Results:
    CHIMIOTHERAPIE AVEC OU SANS ANTICOAGULATION PREVENTIVE DANS LES CANCERS DU PANCREAS METASTATIQUES

    Summary
    EudraCT number
    		 2007-002115-59
    Trial protocol
    		 FR  
    Global end of trial date
    06 Nov 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D07-2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00662688
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GERCOR
    Sponsor organisation address
    151 rue du faubourg saint Antoine, PARIS, France, 75011
    Public contact
    Regulatory Affairs, GERCOR, 33 1 40 29 85 00, regulatory.affairs@gercor.com.fr
    Scientific contact
    Regulatory Affairs, GERCOR, 33 140 29 85 00, regulatory.affairs@gercor.com.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
    06 Mar 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jun 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrated that preventive anticoagulation with dalteparin reduces the number of thromboembolic events in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine
    Protection of trial subjects
    Prior medication is not required. Antiemetic agents, anti-diarrhea and Hematopoietic growth factor may be used if necessary.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 May 2008
    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: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    19
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From May 2008 to February 2011, 42 patients were enrolled in the study. the study was conducted in France, in 8 active centres: Hôpital Saint Antoine, Hôpital Pitié Salpêtrière , Hôpital Bichat (Paris) , CH Montfermeil, CH Meaux , Hôpital Foch (Suresnes), CH Draguignan, CH Antibes

    Pre-assignment
    Screening details
    		 Histologically confirmed adenocarcinoma of the pancreas, measurable disease defined as ≥ 2cm by CT scan or ≥1cm by spiral CT scan or MRI, No progressive thrombo-embolic disease, No adenocarcinoma of the biliary tract or ampulla of Vater, No known CNS mestastases.

    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
    		 ARM A : Chemotherapy alone
    Arm description
    		 Chemotherapy at the investigator's discretion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine type Burris ou Gemcitabine type "Tempero" modifié

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    association Gemcitabine - Tarceva according TNCD

    Investigational medicinal product name
    sel de platine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    oxaliplatine or cisplatine

    Arm title
    		 ARM B : Dalteparin plus chemotherapy
    Arm description
    		 Dalteparin combinated with chemotherapy at the investigator's discretion and according to the THESAURUS National of digestive cancerology 2008 of TNCD
    Arm type
    		 Experimental

    Investigational medicinal product name
    DALTEPARIN
    Investigational medicinal product code
    Other name
    FRAGMINE
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    500UI/ day

    Number of subjects in period 1 [1]
    		ARM A : Chemotherapy alone ARM B : Dalteparin plus chemotherapy
    Started
    22
    19
    Completed
    22
    19
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 23 patients were enrolled in arm A but 1 subject have withdraw consent after the randomization. 22 patients (arm A) were analysed

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ARM A : Chemotherapy alone
    Reporting group description
    		 Chemotherapy at the investigator's discretion

    Reporting group title
    ARM B : Dalteparin plus chemotherapy
    Reporting group description
    		 Dalteparin combinated with chemotherapy at the investigator's discretion and according to the THESAURUS National of digestive cancerology 2008 of TNCD

    Reporting group values
    		 ARM A : Chemotherapy alone ARM B : Dalteparin plus chemotherapy Total
    Number of subjects
    		 22 19 41
    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)
    		 11 8 19
        From 65-84 years
    		 11 11 22
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 61.8 (43.6 to 76.7) 64.1 (46.3 to 78.6) -
    Gender categorical
    Units: Subjects
        Female
    		 10 8 18
        Male
    		 12 11 23
    Thromboembolic history
    Units: Subjects
        No
    		 22 17 39
        Pulmonary embolism
    		 0 0 0
        Deep vein thrombosis
    		 0 0 0
        Others (exp. infarction, stenosis, AMI)
    		 0 2 2
        Portal vein thrombosis
    		 0 0 0
    Tumor localization
    Units: Subjects
        head of the pancreas
    		 12 6 18
        Body - tail of the pancreas
    		 10 13 23
    Tumor Surgery
    Units: Subjects
        Tumor removal
    		 0 1 1
        No surgery
    		 22 18 40
    adjuvant chemotherapy
    Units: Subjects
        Yes
    		 0 1 1
        No
    		 22 18 40
    Number of metastatic sites
    Units: Subjects
        1 site
    		 14 10 24
        2 sites
    		 7 8 15
        3 sites
    		 0 1 1
        4 sites
    		 1 0 1
        5 sites
    		 0 0 0
    Type of metastatic disease
    Units: Subjects
        Synchronous disease
    		 22 18 40
        Metachronous disease
    		 0 1 1
    Performans status (ECOG)
    Units: Subjects
        ECOG-PS 0
    		 4 6 10
        ECOG -PS 1
    		 13 9 22
        ECOG - PS 2
    		 5 4 9
    Factor II mutation
    Units: Subjects
        Yes
    		 1 0 1
        No
    		 8 3 11
        Unknown
    		 13 16 29
    Factor V mutation
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 5 3 8
        Unknown
    		 17 16 33
    Activated protein C resistance
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 9 11 20
        Unknown
    		 13 8 21
    Chemotherapy prescribed
    Units: Subjects
        Gemcitabine type "Burris"
    		 4 4 8
        Gemcitabine - Erlotinib
    		 4 3 7
        Gemcitabine - platinium salt
    		 5 4 9
        Gemcitabine - type "Tempero" modified
    		 8 7 15
        FOLFIRINOX
    		 1 1 2
    End of treatment reasons
    Units: Subjects
        Thromboembolic events
    		 7 2 9
        Toxicity
    		 1 2 3
        intercurrent medical event
    		 1 1 2
        patient choice
    		 1 4 5
        Investigator decision
    		 2 1 3
        Lost of follow-up
    		 1 0 1
        Death (due to disease progression)
    		 7 7 14
        other reason
    		 2 1 3
        Anticoagulation stop more 21 days
    		 0 1 1
    Weight
    Units: kilogram(s)
        median (full range (min-max))
    		 64.8 (44 to 88) 69.8 (46 to 92) -
    Height
    Units: centimetres
        median (full range (min-max))
    		 165.7 (153 to 180) 170.4 (158 to 192) -
    Absolute neutrophil count
    Units: /mm3
        median (full range (min-max))
    		 6210.6 (2661 to 12700) 5977.7 (3314 to 9281) -
    Hemoglobin
    Units: g/dL
        median (full range (min-max))
    		 12.6 (8.5 to 15.8) 12.9 (9.4 to 15) -
    Platelets
    Units: /mm3
        median (full range (min-max))
    		 337454 (157000 to 625000) 286578 (136000 to 481000) -
    Prothrobin rate
    Units: percent
        median (full range (min-max))
    		 91.2 (72 to 100) 91.3 (64 to 100) -
    Activated partial thromboplastin time
    Units: percent
        median (full range (min-max))
    		 1.08 (0.9 to 1.73) 0.99 (0.8 to 1.3) -
    Fibrinogen
    Units: g/L
        median (full range (min-max))
    		 5.3 (2.9 to 8.4) 4.6 (2.4 to 7.1) -
    C-reactiv protein
    Units: percent
        median (full range (min-max))
    		 109.1 (83 to 155) 108.7 (64 to 154) -
    Protein S
    Units: percent
        median (full range (min-max))
    		 98.1 (66 to 165) 105.3 (56 to 163) -
    antithrombin III
    Units: percent
        median (full range (min-max))
    		 96.7 (60 to 125) 106.3 (69 to 146) -
    Albuminaemia
    Units: g/L
        median (full range (min-max))
    		 36.7 (26 to 46) 36.8 (24 to 49) -
    Creatininemia
    Units: µM
        median (full range (min-max))
    		 68.2 (37 to 106) 77.6 (45 to 116) -
    Total bilirubin
    Units: µM
        median (full range (min-max))
    		 21.4 (2 to 89.9) 11.9 (3.1 to 25.7) -
    Alkaline phosphatase
    Units: UI/L
        median (full range (min-max))
    		 258.6 (64 to 796) 252.4 (49 to 1447) -
    ASAT
    Units: UI/L
        median (full range (min-max))
    		 34.3 (10 to 67) 36.4 (11 to 133) -
    ALAT
    Units: UI/L
        median (full range (min-max))
    		 45.9 (16 to 134) 45.4 (8 to 137) -
    LDH
    Units: UI/L
        median (full range (min-max))
    		 303.1 (89 to 814) 365.9 (129 to 1469) -
    Duration of exposure to dalteparin
    only bras B
    Units: day
        median (full range (min-max))
    		 0 (0 to 0) 286 (7 to 994) -

    End points

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    End points reporting groups
    Reporting group title
    ARM A : Chemotherapy alone
    Reporting group description
    		 Chemotherapy at the investigator's discretion

    Reporting group title
    ARM B : Dalteparin plus chemotherapy
    Reporting group description
    		 Dalteparin combinated with chemotherapy at the investigator's discretion and according to the THESAURUS National of digestive cancerology 2008 of TNCD

    Subject analysis set title
    Clincal toxicity - grade 0
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The adverse events were assessed using the Terminology Criteria for Adevrse Event (CTCAE) version 3.0.

    Subject analysis set title
    Clinical toxicity - grade 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The adverse events were assessed using the Terminology Criteria for Adevrse Event (CTCAE) version 3.0.

    Subject analysis set title
    Clinical toxicity - grade 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The adverse events were assessed using the Terminology Criteria for Adevrse Event (CTCAE) version 3.0.

    Subject analysis set title
    Clinical toxicity - grade 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The adverse events were assessed using the Terminology Criteria for Adevrse Event (CTCAE) version 3.0.

    Subject analysis set title
    Clinical toxicty - grade 4
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The adverse events were assessed using the Terminology Criteria for Adevrse Event (CTCAE) version 3.0.

    Subject analysis set title
    Clinical toxicity - grade Unknown
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The adverse events were assessed using the Terminology Criteria for Adevrse Event (CTCAE) version 3.0.

    Primary: Thromboembolic events

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    End point title
    		 Thromboembolic events [1]
    End point description
    x
    End point type
    Primary
    End point timeframe
    Number of thromboembolic events during anticoagulation treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The recruitment of eligible patients proved very laborious and it was decided to stop the study prematurely. 42 patients were enrolled on 136 planned. Only the safety results (secondary end point) are presented in this report. Indeed an efficiency analysis would not be relevant. The PAM07 study requires for a demonstration of efficacy a total of 124 evaluable patients.
    End point values
    		 ARM A : Chemotherapy alone ARM B : Dalteparin plus chemotherapy
    Number of subjects analysed
    22
    19
    Units: Numbers
    0
    0
    No statistical analyses for this end point

    Secondary: Safety

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    End point title
    		 Safety
    End point description
    Tolerance analysis was performed on the population of patients who received at least one chemotherapy cycle with or without coagulation. Clinical adverse events were graded according to the NCI-CTCAE grading system version 3.0. BRAS A:22 patients BRAS B : 19 patients
    End point type
    Secondary
    End point timeframe
    From randomization to end of treatment
    End point values
    		 Clincal toxicity - grade 0 Clinical toxicity - grade 1 Clinical toxicity - grade 2 Clinical toxicity - grade 3 Clinical toxicty - grade 4 Clinical toxicity - grade Unknown
    Number of subjects analysed
    41
    41
    41
    41
    41
    41
    Units: subjects
        Hematoma
    39
    0
    1
    0
    0
    1
        Hemmorhage
    40
    0
    0
    0
    0
    1
        Epitaxia
    39
    1
    0
    0
    0
    1
        Purpura
    40
    1
    0
    0
    0
    1
        Neutrophil count
    22
    5
    6
    5
    2
    1
        Platelets count
    11
    19
    5
    3
    2
    1
        Anemia
    4
    19
    15
    1
    1
    1
        Nausea
    12
    13
    14
    1
    0
    1
        Vomiting
    18
    14
    7
    1
    0
    1
        diarrhea
    17
    16
    5
    2
    0
    1
        Fever
    31
    6
    2
    1
    0
    1
        palmar-plantar erythrodysesthesia syndrome
    38
    1
    1
    0
    0
    1
        Mucositis
    30
    9
    1
    0
    0
    1
        Neuropathy peripheral
    24
    9
    4
    3
    0
    1
        Alopecia
    29
    9
    2
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date to randomization to the last visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    BRAS A : Chemotherapy alone
    Reporting group description
    		 -

    Reporting group title
    Bras B : Dalteparin plus chemotherapy
    Reporting group description
    		 -

    Serious adverse events
    		 BRAS A : Chemotherapy alone Bras B : Dalteparin plus chemotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 22 (54.55%)
    8 / 19 (42.11%)
         number of deaths (all causes)
    7
    7
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Facial oedema
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cognitive disorder
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Deterioration of general status
         subjects affected / exposed
    4 / 22 (18.18%)
    4 / 19 (21.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Food intolerance
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epigastralgia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute cholecystitis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Femoral neck fracture
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    infection without neutropenia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplasia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Suspicion diabetic decompensation
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 BRAS A : Chemotherapy alone Bras B : Dalteparin plus chemotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 22 (100.00%)
    19 / 19 (100.00%)
    Vascular disorders
    Hematoma
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    Epitaxy
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    7 / 22 (31.82%)
    9 / 19 (47.37%)
         occurrences all number
    0
    0
    Blood and lymphatic system disorders
    Neutrophil count
         subjects affected / exposed
    9 / 22 (40.91%)
    9 / 19 (47.37%)
         occurrences all number
    0
    0
    Platelet count
         subjects affected / exposed
    12 / 22 (54.55%)
    17 / 19 (89.47%)
         occurrences all number
    0
    0
    Anemia
         subjects affected / exposed
    19 / 22 (86.36%)
    17 / 19 (89.47%)
         occurrences all number
    0
    0
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    5 / 22 (22.73%)
    4 / 19 (21.05%)
         occurrences all number
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    15 / 22 (68.18%)
    17 / 19 (89.47%)
         occurrences all number
    0
    0
    Vomiting
         subjects affected / exposed
    11 / 22 (50.00%)
    11 / 19 (57.89%)
         occurrences all number
    0
    0
    Diarrhoea
         subjects affected / exposed
    12 / 22 (54.55%)
    11 / 19 (57.89%)
         occurrences all number
    0
    0
    mucositis
         subjects affected / exposed
    5 / 22 (22.73%)
    5 / 19 (26.32%)
         occurrences all number
    0
    0
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    Alopecia
         subjects affected / exposed
    5 / 22 (22.73%)
    6 / 19 (31.58%)
         occurrences all number
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jul 2008
    The 2008 update of the TNCD no longer recommends the combination of Gemcitabine plus Capecitabine as a therapeutic option given the lack of confirmation of the data presented in 2005. Thus, we propose to modify the PAM 07 protocol by allowing the investigator to choose the chemotherapy regimen based on the updated version of the TNCD: - Gemcitabine of the Burris type, - gemcitabine-erlotinib - Gemcitabine-Platinum Salts (oxaliplatin or cisplatin) for patients with IP = 0, - Gemcitabine FDR of type Tempero
    27 Mar 2009
    List of investigators modified
    28 Sep 2010
    List of investigators modified

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Mar 2011
    Due to a very low inclusion rate, GERCOR have concluded to stop the study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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
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