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    Clinical Trial Results:
    A Phase II study of neoadjuvant chemotherapy given before SCPRT as treatment for patients with MRI-staged operable rectal cancer at high risk of metastatic relapse

    Summary
    EudraCT number
    		 2010-023083-40
    Trial protocol
    		 GB  
    Global end of trial date
    29 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jul 2017
    First version publication date
    09 Jul 2017
    Other versions
    Summary report(s)
    		 COPERNICUS EudraCT final study report version1

    Trial information

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    Trial identification
    Sponsor protocol code
    SPON830-10
    Additional study identifiers
    ISRCTN number
    		 ISRCTN10052456
    US NCT number
    		 NCT01263171
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cardiff University
    Sponsor organisation address
    30-36 Newport Road, Cardiff, United Kingdom, CF24 0DE
    Public contact
    Martina Svodobova, Wales Cancer Trials Unit, 0044 2920687463, COPERNICUS@cardiff.ac.uk
    Scientific contact
    Chris Hurt, Wales Cancer Trials Unit, 0044 2920687463, COPERNICUS@cardiff.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
    01 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal reasearch question is whether in MRI-defined operable rectal cancer patients, it is feasible to treat for eight weeks with oxaliplatin/5-Fluorouracil chemotherapy and then give a short course of preoperative radiotherapy (SCPRT)immediately before surgical removal of the tumour. This will be measured by calculating the proportion of patients successfully completing surgery.
    Protection of trial subjects
    IDMC
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2012
    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: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    35
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 147 were assessed for eligibility. 60 registered. Excluded (n=87)  Not meeting inclusion criteria (n=69) Disease metastatic (n=25) Other aspect of disease e.g. wrong stage, not measurable (n=22) Patient fitness/co-morbidity (n=8) Previous malignancy (n=4) Clinician choice (n=4) Other (n=4) Unknown (n=2)  Declined to participate (n=18)

    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
    		 Single arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Oxaliplatin is administered during neo-adjuvant (OxMdG) and adjuvant chemotherapy (OxMdG or OxCap). Four 14-day cycles of OxMdG during neoadjuvant chemotherapy using Oxaliplatin/5-Fluorouracil (OxMdG). Eight 14 day cycles of OxMdG during adjuvant chemotherapy or eight 14 day cycles of OxCap. Day 1 of each cycle: oxaliplatin 85 mg/m2 IV infusion, over 2 hours, in 250-500 mL 5% glucose.

    Investigational medicinal product name
    5-fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Four 14 day cycles during neo-adjuvant chemotherapy. Eight 14 day cycles during adjuvant chemotherapy Day 1 of each cycle: 5-FU 400 mg/m2 IV bolus injection over 5 minutes

    Investigational medicinal product name
    5-fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Four 14 day cycles during neo-adjuvant chemotherapy Eight 14 day cycles during adjuvant chemotherapy Starting Day 1 of each cycle: 5-FU 2400 mg/m2 IV infusion over 46 hours

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eight 14 day cycles during adjuvant chemotherapy as alternative to 5-FU Day 1, evening: Capecitabine 1000 mg/m2 p.o. COPERNICUS Version: 4.1 Date: 17th October 2013 EudraCT No.: 2010-023083-40 Page 68 of 90 Day 2-9: Capecitabine orally 1000 mg/m2 p.o.twice daily Day 10, morning: Capecitabine orally 1000 mg/m2 p.o. Days 11-14: no treatment

    Number of subjects in period 1
    		Single arm
    Started
    60
    Completed
    57
    Not completed
    3
         Consent withdrawn by subject
    1
         Physician decision
    1
         Adverse event, non-fatal
    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
    		 60 60
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 63 (56.5 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 44 44
    ECOG performance status
    Units: Subjects
        Zero
    		 55 55
        One
    		 5 5
    Type of primary tumour
    Units: Subjects
        Adenocarcinoma
    		 60 60
        Missing
    		 0 0
    Rigid sigmoidoscopy
    Units: Subjects
        Performed
    		 34 34
        Not performed
    		 25 25
        Unknown
    		 1 1
    MRI-T stage
    Units: Subjects
        T2
    		 1 1
        T3a
    		 17 17
        T3b
    		 24 24
        T3c
    		 14 14
        T3d
    		 1 1
        T4a
    		 3 3
    MRI-N stage
    Units: Subjects
        N0
    		 7 7
        N1
    		 39 39
        N2
    		 14 14
    MRI-CRM involvement
    Units: Subjects
        Clear
    		 59 59
        Missing data
    		 1 1
    MRI-Extramural vascular invasion
    Units: Subjects
        Positive
    		 25 25
        Negative
    		 35 35
        Missing
    		 0 0
    Predominant differentiation of primary tumour
    Units: Subjects
        Well
    		 5 5
        Moderate
    		 49 49
        Poor
    		 2 2
        Unknown
    		 4 4
    Number of baseline MRI risk factors out of T>=3c or N1-2 or EMVI+
    Units: Subjects
        One
    		 35 35
        Two
    		 14 14
        Three
    		 11 11
        Missing EMVI data
    		 0 0
    Time from histopathological diagnosis to registration
    Units: Days
        median (inter-quartile range (Q1-Q3))
    		 34.5 (28.5 to 46.5) -
    Rigid sigmoidoscopy-time from sigmoidoscopy to registration
    Units: Days
        median (inter-quartile range (Q1-Q3))
    		 44.5 (35 to 54) -
    Rigid sigmoidoscopy-distance to anal verge of inferior aspect of tumour
    Units: millimetres
        median (inter-quartile range (Q1-Q3))
    		 80 (60 to 100) -
    Time from MRI scan to registration
    Units: Weeks
        median (inter-quartile range (Q1-Q3))
    		 3.7 (2.6 to 4.6) -
    MRI-Craniocaudal length
    Units: millimetres
        arithmetic mean (standard deviation)
    		 49.1 ± 11.9 -
    MRI-height from anal verge
    Units: millimetres
        arithmetic mean (standard deviation)
    		 78.7 ± 21.5 -

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 -

    Primary: Efficacy-proportion of patients having surgery

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    End point title
    		 Efficacy-proportion of patients having surgery [1]
    End point description
    End point type
    Primary
    End point timeframe
    Up to surgery
    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: This is a single arm study and no comparison is being made
    End point values
    		 Single arm
    Number of subjects analysed
    60
    Units: Subjects
        Had surgery
    57
        Did not have surgery
    3
    No statistical analyses for this end point

    Secondary: Compliance-achieved total dose of 5FU/capecitabine (neo-adjuvant)

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    End point title
    		 Compliance-achieved total dose of 5FU/capecitabine (neo-adjuvant)
    End point description
    End point type
    Secondary
    End point timeframe
    During neo-adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    60
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    100 (97 to 100)
    No statistical analyses for this end point

    Secondary: Compliance-achieved dose intensity for 5FU/capecitabine (neo-adjuvant)

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    End point title
    		 Compliance-achieved dose intensity for 5FU/capecitabine (neo-adjuvant)
    End point description
    End point type
    Secondary
    End point timeframe
    During neo-adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    60
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    100 (75 to 100)
    No statistical analyses for this end point

    Secondary: Compliance-achieved total dose of 5FU/capecitabine during adjuvant chemotherapy

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    End point title
    		 Compliance-achieved total dose of 5FU/capecitabine during adjuvant chemotherapy
    End point description
    End point type
    Secondary
    End point timeframe
    During adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    45
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    80 (5 to 88)
    No statistical analyses for this end point

    Secondary: Compliance-achieved dose intensity of 5FU/capecitabine (adjuvant)

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    End point title
    		 Compliance-achieved dose intensity of 5FU/capecitabine (adjuvant)
    End point description
    End point type
    Secondary
    End point timeframe
    During adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    45
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    63 (5 to 81)
    No statistical analyses for this end point

    Secondary: Compliance-achieved total dose of oxaliplatin (neo-adjuvant)

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    End point title
    		 Compliance-achieved total dose of oxaliplatin (neo-adjuvant)
    End point description
    End point type
    Secondary
    End point timeframe
    During neo-adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    60
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    100 (93 to 100)
    No statistical analyses for this end point

    Secondary: Compliance-achieved dosse intensity of oxaliplatin (neo-adjuvant)

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    End point title
    		 Compliance-achieved dosse intensity of oxaliplatin (neo-adjuvant)
    End point description
    End point type
    Secondary
    End point timeframe
    During neo-adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    60
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    100 (75 to 100)
    No statistical analyses for this end point

    Secondary: Compliance-achieved total dose of oxaliplatin (adjuvant)

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    End point title
    		 Compliance-achieved total dose of oxaliplatin (adjuvant)
    End point description
    End point type
    Secondary
    End point timeframe
    During adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    45
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    58 (0 to 98)
    No statistical analyses for this end point

    Secondary: Compliance-achieved dose intensity of oxaliplatin (adjuvant)

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    End point title
    		 Compliance-achieved dose intensity of oxaliplatin (adjuvant)
    End point description
    End point type
    Secondary
    End point timeframe
    During adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    45
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    45 (0 to 77)
    No statistical analyses for this end point

    Secondary: Compliance-achieved planned dose for radiotherapy

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    End point title
    		 Compliance-achieved planned dose for radiotherapy
    End point description
    End point type
    Secondary
    End point timeframe
    During radiotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    58
    Units: percentage
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Pathological complete regression

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    End point title
    		 Pathological complete regression
    End point description
    End point type
    Secondary
    End point timeframe
    Post-surgery
    End point values
    		 Single arm
    Number of subjects analysed
    57
    Units: Number of patients
    7
    No statistical analyses for this end point

    Secondary: Biopsy tumour cell density

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    End point title
    		 Biopsy tumour cell density
    End point description
    End point type
    Secondary
    End point timeframe
    Post-surgery
    End point values
    		 Single arm
    Number of subjects analysed
    57
    Units: Density
        median (inter-quartile range (Q1-Q3))
    37.2 (22.7 to 44.2)
    No statistical analyses for this end point

    Secondary: Resection greatest tumour cell density

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    End point title
    		 Resection greatest tumour cell density
    End point description
    End point type
    Secondary
    End point timeframe
    Post-surgery
    End point values
    		 Single arm
    Number of subjects analysed
    57
    Units: Density
        median (inter-quartile range (Q1-Q3))
    21.4 (2.7 to 39.1)
    No statistical analyses for this end point

    Secondary: Resection lumenal tumour cell density

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    End point title
    		 Resection lumenal tumour cell density
    End point description
    End point type
    Secondary
    End point timeframe
    Post-surgery
    End point values
    		 Single arm
    Number of subjects analysed
    57
    Units: Density
        median (inter-quartile range (Q1-Q3))
    17.6 (2.7 to 34.4)
    No statistical analyses for this end point

    Secondary: Resection whole tumour cell density

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    End point title
    		 Resection whole tumour cell density
    End point description
    End point type
    Secondary
    End point timeframe
    Post-surgery
    End point values
    		 Single arm
    Number of subjects analysed
    57
    Units: Density
        median (inter-quartile range (Q1-Q3))
    8.7 (1.3 to 16.1)
    No statistical analyses for this end point

    Secondary: Resction whole TCD as % of biopsy TCD

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    End point title
    		 Resction whole TCD as % of biopsy TCD
    End point description
    End point type
    Secondary
    End point timeframe
    Post-surgery
    End point values
    		 Single arm
    Number of subjects analysed
    57
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    19.4 (3.2 to 53.8)
    No statistical analyses for this end point

    Secondary: Downstage of T-stage

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    End point title
    		 Downstage of T-stage
    End point description
    End point type
    Secondary
    End point timeframe
    Post neo-adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    60
    Units: Number of patients
    44
    No statistical analyses for this end point

    Secondary: Downstage of N stage

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    End point title
    		 Downstage of N stage
    End point description
    End point type
    Secondary
    End point timeframe
    Post neo-adjuvant chemotherapy
    End point values
    		 Single arm
    Number of subjects analysed
    60
    Units: Number of patients
    36
    No statistical analyses for this end point

    Secondary: Tumour regression grade

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    End point title
    		 Tumour regression grade
    End point description
    End point type
    Secondary
    End point timeframe
    Post-surgery
    End point values
    		 Single arm
    Number of subjects analysed
    57
    Units: Number of patients
        No regression
    7
        Minimal regression
    17
        Moderate regression
    14
        Good regression
    12
        Complete regression
    7
        Unknown
    0
    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
    Overall
    End point values
    		 Single arm
    Number of subjects analysed
    60
    Units: percent
        number (confidence interval 95%)
    86.2 (74.3 to 92.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Neo-adjuvant
    Reporting group description
    		 -

    Reporting group title
    Adjuvant
    Reporting group description
    		 Adjuvant chemotherapy after surgery

    Reporting group title
    Post-surgery complications
    Reporting group description
    		 -

    Serious adverse events
    		 Neo-adjuvant Adjuvant Post-surgery complications
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 60 (40.00%)
    15 / 45 (33.33%)
    0 / 57 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Thrombocytopenia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic leak
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thrombosis right arm
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 45 (2.22%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular access complication
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thromboembolic event
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 45 (2.22%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 45 (2.22%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 45 (6.67%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonic/bowel obstruction
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 45 (2.22%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Faecal impaction
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 45 (2.22%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mechanical bowel obstruction
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 45 (2.22%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal anastomatic leak
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in right loin
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 45 (2.22%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal ascites
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucositis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laparotomy and small bowel resection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 45 (2.22%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anorectal infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory infection
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 45 (4.44%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 45 (2.22%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chest pain
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gout (joint infection)
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Wound infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 45 (0.00%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Neo-adjuvant Adjuvant Post-surgery complications
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 60 (20.00%)
    5 / 45 (11.11%)
    10 / 57 (17.54%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    12 / 60 (20.00%)
    5 / 45 (11.11%)
    0 / 57 (0.00%)
         occurrences all number
    12
    5
    0
    Surgical and medical procedures
    Second operation required
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 45 (0.00%)
    4 / 57 (7.02%)
         occurrences all number
    0
    0
    4
    Infections and infestations
    Pelvic infection/collection requiring draining
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 45 (0.00%)
    10 / 57 (17.54%)
         occurrences all number
    0
    0
    10
    Serious infection-wound
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 45 (0.00%)
    6 / 57 (10.53%)
         occurrences all number
    0
    0
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    N/A
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