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    Clinical Trial Results:
    EXCITE: Erbitux, Xeloda, Campto, Irradiation Then Excision for locally advanced rectal cancer. (North West Clinical Oncology Group-04 on behalf of the NCRI rectal cancer subgroup)

    Summary
    EudraCT number
    		 2007-006701-25
    Trial protocol
    		 GB  
    Global end of trial date
    31 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2018
    First version publication date
    07 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UCL/07/132
    Additional study identifiers
    ISRCTN number
    		 ISRCTN86285819
    US NCT number
    		 NCT00972881
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MHRA CTA No.: 20363/0228/001-0001
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Joint Research Office, Gower Street, London, United Kingdom, WC1E 6BT
    Public contact
    ctc.sponsor@ucl.ac.uk, University College London, ctc.sponsor@ucl.ac.uk
    Scientific contact
    ctc.sponsor@ucl.ac.uk, University College London, ctc.sponsor@ucl.ac.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
    25 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In a phase II setting in MRI-defined locally advanced rectal cancer to assess the downstaging effectiveness of preoperative chemoradiotherapy using capecitabine/ irinotecan/cetuximab plus radiotherapy using the primary endpoint of clear (R0) circumferential resection margin rate.
    Protection of trial subjects
    UCL CTC provided safety information to the TMG on a periodic basis for review. Trial safety data was monitored to identify: • New adverse reactions to the trial treatment regimen or individual trial treatments; • A higher incidence in rare adverse events than is stated in the IB/SPC for a trial treatment; • Trial related events that are not considered related to the trial treatment regimen. Should UCL CTC have identified or suspected any issues concerning patient safety at any point throughout the trial, the CI or TMG would have been consulted for their opinion.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2009
    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
    Ireland: 12
    Country: Number of subjects enrolled
    United Kingdom: 70
    Worldwide total number of subjects
    82
    EEA total number of subjects
    82
    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)
    52
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 82 patients were recruited in total, 70 within the United Kingdom and 12 in the Republic of Ireland. The trial was opened to recruitment on the 30/03/2009, the first patient was recruited on the 09/04/2009, the last patient was recruited on the 25/10/2011.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall Trial
    Arm description
    		 Patients were treated with pelvic radiotherapy to a planned volume at a dose of 45 Gy in 25 daily fractions of 1.8 Gy treating 5 days per week from Monday-Friday for five weeks in total. Concurrently they received oral capecitabine at 650 mg/m2 bd for 5 days per week on the days of radiotherapy only. In addition they received IV irinotecan at 60 mg/m2 once per week during the 1st, 2nd, 3rd and 4th weeks of radiotherapy. In addition, they received a loading dose of IV cetuximab at 400 mg/m2 one week before the commencement of radiotherapy then at 250 mg/m2 once per week during the 1st, 2nd, 3rd, 4th and 5th weeks of radiotherapy. Six weeks post completion of chemoradiation (CRT) patients received an MRI scan to judge response. At eight weeks post CRT patients underwent surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capecitabine at 650 mg/m2 bd for 5 days per week on the days of radiotherapy only.

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Irinotecan Hydrochloride, Campto
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV irinotecan at 60 mg/m2 once per week during the 1st, 2nd, 3rd and 4th weeks of radiotherapy.

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Erbitux
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    loading dose of iv cetuximab at 400 mg/m2 one week before the commencement of radiotherapy then at 250 mg/m2 once per week during weeks 1, 2, 3, 4 and 5 radiotherapy i.e. six doses of cetuximab in total

    Number of subjects in period 1
    		Overall Trial
    Started
    82
    Completed
    80
    Not completed
    2
         Physician decision
    1
         poor performance patient did not start treatment
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 82 82
    Age categorical
    Age at registration (years)
    Units: Subjects
        Adults (18-64 years)
    		 52 52
        From 65-84 years
    		 30 30
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 61 61
    WHO Performance Status
    Units: Subjects
        WHO PS 0
    		 62 62
        WHO PS 1
    		 20 20
    Defunctioning stoma
    Units: Subjects
        Ileostomy
    		 3 3
        Colostomy
    		 4 4
        None
    		 75 75
    T-stage
    Units: Subjects
        T2
    		 6 6
        T3
    		 67 67
        T4
    		 9 9
    N Stage
    Units: Subjects
        N0
    		 14 14
        N1
    		 42 42
        N2
    		 26 26
    M-Stage
    Units: Subjects
        M0
    		 82 82
    Mesorectal edge on MRI scan
    Units: Subjects
        Potentially involved (=<1mm gap)
    		 43 43
        Involved, not breached
    		 22 22
        Breached
    		 17 17
    Distance of distal end of tumour from anal verge using rigid sigmoidoscopy (mm)
    n=63
    Units: mm
        median (full range (min-max))
    		 50 (0 to 130) -
    Distance of distal end of tumour from anal verge using MRI (mm)
    n=78
    Units: mm
        median (full range (min-max))
    		 50 (0 to 120) -
    Maximum superior-inferior tumour dimension (mm)
    n=76
    Units: mm
        median (full range (min-max))
    		 51 (5 to 110) -
    Maximum tumour diameter in a plane perpendicular to the longitudinal central axis of the rectum (mm)
    Median (range) [n-55] Not measurable [n=25] Missing = [n=2]
    Units: mm
        median (full range (min-max))
    		 28 (10 to 100) -

    End points

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    End points reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 Patients were treated with pelvic radiotherapy to a planned volume at a dose of 45 Gy in 25 daily fractions of 1.8 Gy treating 5 days per week from Monday-Friday for five weeks in total. Concurrently they received oral capecitabine at 650 mg/m2 bd for 5 days per week on the days of radiotherapy only. In addition they received IV irinotecan at 60 mg/m2 once per week during the 1st, 2nd, 3rd and 4th weeks of radiotherapy. In addition, they received a loading dose of IV cetuximab at 400 mg/m2 one week before the commencement of radiotherapy then at 250 mg/m2 once per week during the 1st, 2nd, 3rd, 4th and 5th weeks of radiotherapy. Six weeks post completion of chemoradiation (CRT) patients received an MRI scan to judge response. At eight weeks post CRT patients underwent surgery.

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint [1]
    End point description
    Histologically confirmed R0 resection rate i.e. the carcinoma is resected with margins clear by >1mm
    End point type
    Primary
    End point timeframe
    Resection was recommended 8 weeks after completion of 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 page would not allow us to enter a single arm comparison group, the error stated two arms had to be selected, whereas the help said a single arm can be selected if it is a single arm trial. Excite is single arm and it would not accept this so we deleted the data to be able to submit and have emailed EudraCT for guidance.
    End point values
    		 Overall Trial
    Number of subjects analysed
    82
    Units: Number of R0 resections
        R0
    67
        R1
    8
        R2
    1
        Did not have surgery
    6
    No statistical analyses for this end point

    Secondary: Radiotherapy compliance

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    End point title
    		 Radiotherapy compliance
    End point description
    End point type
    Secondary
    End point timeframe
    Completion of radiotherapy
    End point values
    		 Overall Trial
    Number of subjects analysed
    82
    Units: Compliance rate
        Full dose (45 Gy) received without delay as per pr
    47
        Full dose (45 Gy) received with delay due to adver
    29
        Dose reduction
    4
        Did not start
    2
    No statistical analyses for this end point

    Secondary: Grade 3 toxicity

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    End point title
    		 Grade 3 toxicity
    End point description
    End point type
    Secondary
    End point timeframe
    Grade 3 adverse events occurring during and up to 4 weeks following completion of CRT (based on 81 patients that had some treatment)
    End point values
    		 Overall Trial
    Number of subjects analysed
    81
    Units: Grade 3 toxicity
        Anaemia
    1
        Leucopoenia
    5
        Thrombocytopenia
    0
        Neutropenia
    4
        Febrile neutropenia
    1
        Any haematological AE
    10
        Diarrhoea
    20
        Acneiform rash
    7
        Fatigue
    6
        Dehydration
    1
        Pyrexia/Fever
    1
        Headache
    1
        Insomnia
    1
        Taste disturbance
    1
        Nausea
    1
        Vomiting
    1
        Urticaria
    1
        Other rash/skin reactions
    7
        Anal/rectal/bowel complications
    6
        Thrombotic event
    1
        Other
    4
        Any non-haematological adverse event
    36
        Any adverse event
    38
    No statistical analyses for this end point

    Secondary: Grade 4 toxicity

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    End point title
    		 Grade 4 toxicity
    End point description
    End point type
    Secondary
    End point timeframe
    Grade 4 adverse events occurring during and up to 4 weeks following completion of CRT (based on 81 patients that had some treatment)
    End point values
    		 Overall Trial
    Number of subjects analysed
    81
    Units: Grade 4 adverse events
        Anaemia
    1
        Leucopoenia
    1
        Thrombocytopenia
    1
        Neutropenia
    1
        Febrile neutropenia
    1
        Any haematological AE
    4
        Diarrhoea
    0
        Acneiform rash
    0
        Fatigue
    0
        Dehydration
    0
        Pyrexia/Fever
    0
        Headache
    0
        Insomnia
    0
        Taste disturbance
    0
        Nausea
    0
        Vomiting
    0
        Urticaria
    0
        Other rash/skin reactions
    0
        Anal/rectal/bowel complications
    0
        Thrombotic event
    5
        Other
    1
        Any non-haematological adverse event
    6
        Any adverse event
    10
    No statistical analyses for this end point

    Secondary: pathological complete response

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    End point title
    		 pathological complete response
    End point description
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Overall Trial
    Number of subjects analysed
    82
    Units: tumour regression grade
        grade 0
    10
        grade 1
    11
        grade 2
    18
        grade 3
    17
        grade 4
    6
        grade 5 cPR
    14
        did not have surgery
    6
    No statistical analyses for this end point

    Secondary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 36 months post registration
    End point values
    		 Overall Trial
    Number of subjects analysed
    82
    Units: 36 months PFS
        number (confidence interval 95%)
    67 (55 to 76)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    up to 36 months from registration
    End point values
    		 Overall Trial
    Number of subjects analysed
    82
    Units: 36 month OS
        number (confidence interval 95%)
    80 (69 to 87)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    signing of informed consent and 36 months after patient completes CRT
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 Patients were treated with pelvic radiotherapy to a planned volume at a dose of 45 Gy in 25 daily fractions of 1.8 Gy treating 5 days per week from Monday-Friday for five weeks in total. Concurrently they received oral capecitabine at 650 mg/m2 bd for 5 days per week on the days of radiotherapy only. In addition they received IV irinotecan at 60 mg/m2 once per week during the 1st, 2nd, 3rd and 4th weeks of radiotherapy. In addition, they received a loading dose of IV cetuximab at 400 mg/m2 one week before the commencement of radiotherapy then at 250 mg/m2 once per week during the 1st, 2nd, 3rd, 4th and 5th weeks of radiotherapy. Six weeks post completion of chemoradiation (CRT) patients received an MRI scan to judge response. At eight weeks post CRT patients underwent surgery.

    Serious adverse events
    		 Single arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 81 (28.40%)
         number of deaths (all causes)
    15
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    vessel injury - artery
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    hypotension
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    vasovagal episode
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    pulmonary embolism
         subjects affected / exposed
    2 / 81 (2.47%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    thrombosis/thrombus/embolism
         subjects affected / exposed
    2 / 81 (2.47%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    4 / 81 (4.94%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    febrile neutropenia
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Lethargy
         subjects affected / exposed
    2 / 81 (2.47%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    pyrexia
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    asthenia
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    diarrhoea
         subjects affected / exposed
    10 / 81 (12.35%)
         occurrences causally related to treatment / all
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    bowel obstruction
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    vomitting
         subjects affected / exposed
    2 / 81 (2.47%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 81 (2.47%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Salmonella
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    perianal abscess
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    respiratory infection
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    dehydration
         subjects affected / exposed
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Single arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 81 (85.19%)
    Investigations
    alanine aminotransferase increased
         subjects affected / exposed
    28 / 81 (34.57%)
         occurrences all number
    28
    alkaline phosphatase increased
         subjects affected / exposed
    7 / 81 (8.64%)
         occurrences all number
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    Blood bilirubin increased
         subjects affected / exposed
    9 / 81 (11.11%)
         occurrences all number
    9
    creatinine increased
         subjects affected / exposed
    10 / 81 (12.35%)
         occurrences all number
    10
    GGT increased
         subjects affected / exposed
    17 / 81 (20.99%)
         occurrences all number
    17
    Neutrophil count decreased
         subjects affected / exposed
    24 / 81 (29.63%)
         occurrences all number
    24
    other investigations
         subjects affected / exposed
    22 / 81 (27.16%)
         occurrences all number
    22
    platelet count decreased
         subjects affected / exposed
    13 / 81 (16.05%)
         occurrences all number
    13
    white blood cell decreased
         subjects affected / exposed
    40 / 81 (49.38%)
         occurrences all number
    40
    Injury, poisoning and procedural complications
    dermatitis radiation
         subjects affected / exposed
    11 / 81 (13.58%)
         occurrences all number
    11
    Other injury, poisoning and procedural complication
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    Vascular disorders
    Hypotension
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    Nervous system disorders
    dizziness
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    Dysgeusia
         subjects affected / exposed
    8 / 81 (9.88%)
         occurrences all number
    8
    lethargy
         subjects affected / exposed
    19 / 81 (23.46%)
         occurrences all number
    19
    Blood and lymphatic system disorders
    Anemia/Hemoglobin increased
         subjects affected / exposed
    46 / 81 (56.79%)
         occurrences all number
    46
    General disorders and administration site conditions
    fatigue
         subjects affected / exposed
    46 / 81 (56.79%)
         occurrences all number
    46
    Fever neonatal
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    28 / 81 (34.57%)
         occurrences all number
    28
    Anal pain
         subjects affected / exposed
    8 / 81 (9.88%)
         occurrences all number
    8
    Anal/oral mucositis
         subjects affected / exposed
    17 / 81 (20.99%)
         occurrences all number
    17
    Constipation
         subjects affected / exposed
    30 / 81 (37.04%)
         occurrences all number
    30
    Diarrhoea
         subjects affected / exposed
    59 / 81 (72.84%)
         occurrences all number
    59
    Dyspepsia
         subjects affected / exposed
    10 / 81 (12.35%)
         occurrences all number
    10
    lower gastrointestinal hemorrhage
         subjects affected / exposed
    7 / 81 (8.64%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    25 / 81 (30.86%)
         occurrences all number
    25
    Proctitis
         subjects affected / exposed
    7 / 81 (8.64%)
         occurrences all number
    7
    rectal pain
         subjects affected / exposed
    19 / 81 (23.46%)
         occurrences all number
    19
    vomiting
         subjects affected / exposed
    13 / 81 (16.05%)
         occurrences all number
    13
    Skin and subcutaneous tissue disorders
    alopecia
         subjects affected / exposed
    6 / 81 (7.41%)
         occurrences all number
    6
    Erythema multiforme
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    other skin and subcutaneous tissue disorders
         subjects affected / exposed
    8 / 81 (9.88%)
         occurrences all number
    8
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    24 / 81 (29.63%)
         occurrences all number
    24
    rash acneiform
         subjects affected / exposed
    69 / 81 (85.19%)
         occurrences all number
    69
    skin ulceration
         subjects affected / exposed
    4 / 81 (4.94%)
         occurrences all number
    4
    Psychiatric disorders
    insomnia
         subjects affected / exposed
    15 / 81 (18.52%)
         occurrences all number
    15
    Renal and urinary disorders
    Cystitis noninfective
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    urinary frequency
         subjects affected / exposed
    8 / 81 (9.88%)
         occurrences all number
    8
    Infections and infestations
    Anorectal infection
         subjects affected / exposed
    5 / 81 (6.17%)
         occurrences all number
    5
    other infections and infestations
         subjects affected / exposed
    4 / 81 (4.94%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    anorexia
         subjects affected / exposed
    14 / 81 (17.28%)
         occurrences all number
    14
    hypernatremia/hyponatremia
         subjects affected / exposed
    17 / 81 (20.99%)
         occurrences all number
    17
    hypermanesemia/hypomagnesemia
         subjects affected / exposed
    19 / 81 (23.46%)
         occurrences all number
    19
    hypoalbuminia
         subjects affected / exposed
    22 / 81 (27.16%)
         occurrences all number
    22
    hypocalcemia/hypercalcemia
         subjects affected / exposed
    13 / 81 (16.05%)
         occurrences all number
    13
    hypokalemia/hyperkalemia
         subjects affected / exposed
    21 / 81 (25.93%)
         occurrences all number
    21

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2008
    Trial documentation changed to advise not to take St John's Wort whilst receiving Irinotecan, exclusion criteria and patient information sheet changed.
    28 Jul 2008
    •Section 14 Pharmacovigilance- whole section has been replaced with current CTC PV template. Contains more detailed and specific information with regards to reporting procedures.
    08 Aug 2008
    Change in concentration of cetuximab increasing from 2mg/ml to 5mg/ml
    16 Oct 2008
    • Introduction- additional paragraph added regarding Kras testing • Statistical considerations- last paragraph amended to reflect the new additional paragraph regarding Kras • Pharmacovigilance- whole section deleted and new CTC template inserted to reflect current procedures • Ancillary studies- new paragraph added regarding Kras testing
    24 Feb 2009
    Amendment to protocol and PIL. MRI assessment changed from needing to be within 28 days of start of treatment to registration.
    07 May 2010
    • Increase in recruitment target by an additional 40 patients • Inclusion criteria updated and an increase in baseline investigations timelines • Extra information for quality control of radiotherapy & pathology clarification • Change to trial drug distribution • Monitoring and PV changes and minor administrative amendments
    20 Oct 2010
    Amendment to capecitabine label. Irinotecan now to be supplied from hospital stock and will not need a clinical trial specific label.
    04 Jan 2012
    • Updates to sections 14 (Trial monitoring and Oversight), 15 (Pharmacovigilance), 16 (Incident reporting and Serious Breaches), 17 (Ethics and Regulatory approvals) and 18 (Sponsorship and indemnity) of the protocol to reflect current internal procedures and practices. • Amendment to section 19 (Biological Studies); Addition of further biological Studies, which was previously omitted from the protocol & clarification regarding immunohistopathological investigations.
    22 Jan 2015
    Change of end of trial definition updated to the 31st August 2015 to allow for translational studies to be performed. Timeframe in which adverse events are collected has been amended to 36 months post CRT. Addition of appendix 4 – Translational Studies and Methodology.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    09 Feb 2010
    Interruption to recruitment, 40 patients reached and sites temporarily closed to recruitment, re-opened in August 2010. Reactivation teleconferences held, re-initiation for sites who did not recruit prior to interruption.
    -

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28859058
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