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    Clinical Trial Results:
    A randomised open-labelled multicentre trial of the efficacy of epirubicin, oxaliplatin and capecitabine (EOX) with or without panitumumab in previously untreated advanced oesophago-gastric cancer (REAL3)

    Summary
    EudraCT number
    		 2007-005976-15
    Trial protocol
    		 GB  
    Global end of trial date
    28 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2019
    First version publication date
    14 Jun 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CCR3024
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Royal Marsden NHS Foundation Trust
    Sponsor organisation address
    Downs Road, Sutton, London, United Kingdom, sm25pt
    Public contact
    Claire Saffery, The Royal Marsden NHS Foundation Trust, 020 8661 3637, claire.saffery@rmh.nhs.uk
    Scientific contact
    Claire Saffery, The Royal Marsden NHS Foundation Trust, 020 8661 3637, claire.saffery@rmh.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Jul 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine whether adding panitumumab to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the median overall survival of patients with advanced oesophago-gastric cancer.
    Protection of trial subjects
    Any safety concerns generated from this or other studies of panitumumab could lead to stopping this trial prematurely. Serious adverse events will be reported and evaluated regularly. Any significant observations would result in a formal review and dependent upon the outcome of that review, the study would be terminated or continue. Serious adverse events are also reported to the regulatory authorities within timelines dicated by law. Interim analyses will take place approximately annually to examine safety, scientific validity and the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jun 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 553
    Worldwide total number of subjects
    553
    EEA total number of subjects
    553
    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)
    326
    From 65 to 84 years
    227
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The following assessments will take place during the screening period; Clinical examination & history, WHO performance status, CT scan (chest/abdomen/pelvis), Full blood count, Serum biochemistry, Creatinine clearance, ECG, Pregnancy testing, Quality of life, Biomarkers

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EOC alone
    Arm description
    		 epirubicin, oxaliplatin and capecitabine.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    epirubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg/m2 IV on day 1.

    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
    130mg/m2 IV on day 1.

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1250mg/m2 PO in two divided doses continuously from days 1-21.

    Arm title
    		 EOC + Panitumumab
    Arm description
    		 epirubicin, oxaliplatin, capecitabine and panitumumab
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Epirubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg/m2 IV on day 1.

    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
    100mg/m2 IV on day 1.

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000mg/m2 PO in two divided doses continuously from days 1-21.

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intrauterine use
    Dosage and administration details
    9mg/kg IV on day 1 of each cycle after mEOX chemotherapy.

    Number of subjects in period 1
    		EOC alone EOC + Panitumumab
    Started
    275
    278
    Completed
    266
    276
    Not completed
    9
    2
         Consent withdrawn by subject
    4
    -
         Physician decision
    5
    1
         Had not started prior to study closure
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EOC alone
    Reporting group description
    		 epirubicin, oxaliplatin and capecitabine.

    Reporting group title
    EOC + Panitumumab
    Reporting group description
    		 epirubicin, oxaliplatin, capecitabine and panitumumab

    Reporting group values
    		 EOC alone EOC + Panitumumab Total
    Number of subjects
    		 275 278 553
    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)
    		 168 158 326
        From 65-84 years
    		 107 120 227
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 62 (54 to 68) 63 (56 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 49 46 95
        Male
    		 226 232 458
    Subject analysis sets

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to the study analysed according to the arm to which they were initially randomised. However, patients still on treatment on the 19th October 2011 were censored at this point to ensure that the crossover of patients to standard chemotherapy does not interfere with this analysis.

    Subject analysis sets values
    		 Intention to treat
    Number of subjects
    553
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    326
        From 65-84 years
    227
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    Gender categorical
    Units: Subjects
        Female
    95
        Male
    458

    End points

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    End points reporting groups
    Reporting group title
    EOC alone
    Reporting group description
    		 epirubicin, oxaliplatin and capecitabine.

    Reporting group title
    EOC + Panitumumab
    Reporting group description
    		 epirubicin, oxaliplatin, capecitabine and panitumumab

    Subject analysis set title
    Intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised to the study analysed according to the arm to which they were initially randomised. However, patients still on treatment on the 19th October 2011 were censored at this point to ensure that the crossover of patients to standard chemotherapy does not interfere with this analysis.

    Primary: Overall survival at 1 year

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    End point title
    		 Overall survival at 1 year
    End point description
    Time from Randomisation to death or censored at time last followed up. Data for patients still on treatment were censored at the time of crossover to allow accurate comparison between 2 trial groups.
    End point type
    Primary
    End point timeframe
    One year post last patient randomised
    End point values
    		 EOC alone EOC + Panitumumab
    Number of subjects analysed
    275
    278
    Units: survival percent alive
        number (confidence interval 95%)
    46 (38 to 54)
    33 (26 to 41)
    Statistical analysis title
    		 Overll Survival
    Statistical analysis description
    Overall survival was estimated the Kaplan-Meier method. Groups were compared with the log-rank test and Cox regression analysis to generate Hazard Ratios and 95% CIs.
    Comparison groups
    EOC + Panitumumab v EOC alone
    Number of subjects included in analysis
    553
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.76

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomisation to 30 days post last trial treatment
    Adverse event reporting additional description
    Grade 3-5 toxicities
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 No dictionary
    Dictionary version
    0
    Reporting groups
    Reporting group title
    EOC alone
    Reporting group description
    		 -

    Reporting group title
    EOC + Panitumumab
    Reporting group description
    		 -

    Serious adverse events
    		 EOC alone EOC + Panitumumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    125 / 266 (46.99%)
    133 / 276 (48.19%)
         number of deaths (all causes)
    110
    141
         number of deaths resulting from adverse events
    8
    5
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 266 (0.75%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders - Other, specify
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 266 (0.00%)
    2 / 276 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 266 (3.38%)
    6 / 276 (2.17%)
         occurrences causally related to treatment / all
    10 / 10
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    2 / 266 (0.75%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site reaction
         subjects affected / exposed
    1 / 266 (0.38%)
    2 / 276 (0.72%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    11 / 266 (4.14%)
    9 / 276 (3.26%)
         occurrences causally related to treatment / all
    9 / 13
    8 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic reaction to excipient
         subjects affected / exposed
    3 / 266 (1.13%)
    3 / 276 (1.09%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 266 (1.50%)
    3 / 276 (1.09%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Neurology - Other (Specify)
         subjects affected / exposed
    3 / 266 (1.13%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hemoglobin increased
         subjects affected / exposed
    9 / 266 (3.38%)
    4 / 276 (1.45%)
         occurrences causally related to treatment / all
    1 / 9
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Creatinine increased
         subjects affected / exposed
    3 / 266 (1.13%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haptoglobin decreased
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    7 / 266 (2.63%)
    8 / 276 (2.90%)
         occurrences causally related to treatment / all
    7 / 7
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    3 / 266 (1.13%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation recall reaction (dermatologic)
         subjects affected / exposed
    3 / 266 (1.13%)
    2 / 276 (0.72%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    12 / 266 (4.51%)
    17 / 276 (6.16%)
         occurrences causally related to treatment / all
    12 / 12
    18 / 18
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cardiac disorders
    Cardiac infarction
         subjects affected / exposed
    4 / 266 (1.50%)
    2 / 276 (0.72%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemia
         subjects affected / exposed
    1 / 266 (0.38%)
    2 / 276 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasovagal reaction
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    32 / 266 (12.03%)
    19 / 276 (6.88%)
         occurrences causally related to treatment / all
    36 / 36
    22 / 22
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 266 (0.75%)
    5 / 276 (1.81%)
         occurrences causally related to treatment / all
    1 / 2
    5 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    40 / 266 (15.04%)
    51 / 276 (18.48%)
         occurrences causally related to treatment / all
    50 / 50
    62 / 63
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    3 / 266 (1.13%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal fistula
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemorrhoids
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Esophagitis
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    14 / 266 (5.26%)
    20 / 276 (7.25%)
         occurrences causally related to treatment / all
    18 / 19
    22 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    29 / 266 (10.90%)
    29 / 276 (10.51%)
         occurrences causally related to treatment / all
    31 / 36
    39 / 41
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders - Other, specify
         subjects affected / exposed
    0 / 266 (0.00%)
    3 / 276 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Hemorrhage
         subjects affected / exposed
    5 / 266 (1.88%)
    6 / 276 (2.17%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constitutional symptoms
         subjects affected / exposed
    2 / 266 (0.75%)
    4 / 276 (1.45%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perforation, GI – Select
         subjects affected / exposed
    1 / 266 (0.38%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 266 (0.00%)
    2 / 276 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders - Other, specify
         subjects affected / exposed
    2 / 266 (0.75%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorder - Other, specify
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations - Other, specify
         subjects affected / exposed
    19 / 266 (7.14%)
    30 / 276 (10.87%)
         occurrences causally related to treatment / all
    17 / 19
    43 / 49
         deaths causally related to treatment / all
    0 / 0
    3 / 3
    pulmonary
         subjects affected / exposed
    1 / 266 (0.38%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia nervosa
         subjects affected / exposed
    1 / 266 (0.38%)
    4 / 276 (1.45%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    18 / 266 (6.77%)
    13 / 276 (4.71%)
         occurrences causally related to treatment / all
    19 / 21
    14 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 266 (0.00%)
    1 / 276 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 266 (0.00%)
    2 / 276 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalemia
         subjects affected / exposed
    4 / 266 (1.50%)
    4 / 276 (1.45%)
         occurrences causally related to treatment / all
    4 / 4
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 266 (0.00%)
    9 / 276 (3.26%)
         occurrences causally related to treatment / all
    0 / 0
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic/Lab - Other (Specify)
         subjects affected / exposed
    3 / 266 (1.13%)
    0 / 276 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 EOC alone EOC + Panitumumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    166 / 266 (62.41%)
    187 / 276 (67.75%)
    Nervous system disorders
    Lethargy
         subjects affected / exposed
    35 / 266 (13.16%)
    48 / 276 (17.39%)
         occurrences all number
    35
    48
    Peripheral motor neuropathy
         subjects affected / exposed
    18 / 266 (6.77%)
    4 / 276 (1.45%)
         occurrences all number
    18
    4
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    37 / 266 (13.91%)
    20 / 276 (7.25%)
         occurrences all number
    37
    20
    Neutropenia
         subjects affected / exposed
    74 / 266 (27.82%)
    35 / 276 (12.68%)
         occurrences all number
    74
    35
    Anaemia
         subjects affected / exposed
    15 / 266 (5.64%)
    11 / 276 (3.99%)
         occurrences all number
    15
    11
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    23 / 266 (8.65%)
    23 / 276 (8.33%)
         occurrences all number
    23
    23
    Mucositis management
         subjects affected / exposed
    0 / 266 (0.00%)
    14 / 276 (5.07%)
         occurrences all number
    0
    14
    Diarrhoea
         subjects affected / exposed
    30 / 266 (11.28%)
    48 / 276 (17.39%)
         occurrences all number
    30
    48
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    11 / 266 (4.14%)
    20 / 276 (7.25%)
         occurrences all number
    11
    20
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 266 (0.75%)
    29 / 276 (10.51%)
         occurrences all number
    2
    29
    Hand-foot-syndrome
         subjects affected / exposed
    13 / 266 (4.89%)
    16 / 276 (5.80%)
         occurrences all number
    13
    16
    Infections and infestations
    Infection
         subjects affected / exposed
    33 / 266 (12.41%)
    28 / 276 (10.14%)
         occurrences all number
    33
    28
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    16 / 266 (6.02%)
    10 / 276 (3.62%)
         occurrences all number
    16
    10
    Hypomagnesaemia
         subjects affected / exposed
    0 / 266 (0.00%)
    13 / 276 (4.71%)
         occurrences all number
    0
    13

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Sep 2008
    Update on capecitabine dose for patients on ARM2 Inclusion criteria updated to reflect that patients receiving palliative radiotherapy to sites of disease that are not measurable may be eligible and should be discussed with the chief investigator. Guidance for duration of panitumumab administration for larger patients updated. Info regarding pre medication for panitumumab updated. Updated guidance for capping surface area for largewr patients. Instructions to take water with capecitiabine included. Dose banding for cape for patients in Arm B updated. Additional guidance for management of neutropenia with infection/fever, neutrophil count, renal toc, neurotox, palmar plantarerythmia and allergic reactions. Clarification that certain investigations must take place within 7 days prior to randomization. Updated guidance for management of blood specimens. Updated info stating that copies of all SARs should be copied to Amgen ltd Panitumumab accountability updated.
    01 Oct 2008
    Starting dose for panitumumab for dose level -2 updated. amendment to doses for EOX following dose level implementation. Further dose reduction for cape and oxali implemented due to a further case of G3 diarhoea and G5 infection. Updated guidance for the management of diarhoea.
    01 Apr 2009
    The word Experimental changed to investigational changes throughout. Dose level clarifications provided.
    30 Jul 2009
    Subsection regarding the safety analysis of dose finding exercise added. Information regarding trial team meetings added.
    01 Dec 2009
    EOX in Arm B is referred to as mEOX (modified EOX) throughout. Panitumumab dose is confirmed as 9mg/kg. Cape dose in arm b is confirmed as 1000mg/m2 Results of dosefinding exercise and reason for choice of dose level 0 inserted. Two fatal infusion reactions to panitumumab have been included in the protocol. Background section updated with the resilts of two phase III studies of Pan presented in 2009. Removal of details of dose finding exercise. Now situated in appendix I. Insertion of text regarding management of diarrhea. Insetion of text stating that use of aprepitant is permitted. Removal of dose banding tables for dose level 1. Clairification for procedure regarding blood samples. Addition of KRas wild type versus mutant as an exploratory sub group analysis.
    12 Jul 2010
    Update on the number of patients treated with Panitumumab included. Info on preemptice treatment o reduce likelihood of grade 2 skin tox. Addition of the use of a second quality of life form EQ-5D. ALT or AST can be done, doesn't have to be both. EGFR and KRAS wild type are not required for study entry. Saline volume requirements updated. Infustion reactions guidance updated. Skin tox management updated. Dose banding for epi and oxali using local practice is updated. Guidance for management of persistant fatigue updated. Inclusion of O'Rouke dysphagia grading.
    12 Jan 2011
    Sample size updated. Info that consent must be taken by a clinician only. Doxycycline dose updated. Additional text regarding the first 10 patients who were randomized to arm b with a different dose. Information amended regarding the formal no-comparative interim analysis. Information regarding the interim analysis updated.
    31 Mar 2011
    Information regarding the continued use of panitumumab past 8 cycles included. Panitumumab monotherapy and 12 week CT scans included. Rationale for continuing panitumumab until disease progression inserted. Information regarding the exclusion of the first 19 patients randomized during the dose finding phase. Clarity of assessments which should take place during treatment. UPdated information regarding when quality of life questionnaires should be completed. Additional text regarding follow up after disease progression. Additional text regarding an additional optional blood test and biopsy for ARM B patients. Additional text regarding the sensitivity analyses.

    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
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