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    Clinical Trial Results:
    Short Course Oncology Therapy - A study of adjuvant chemotherapy in colorectal cancer

    Summary
    EudraCT number
    2007-003957-10
    Trial protocol
    GB   DK   ES   SE   DE  
    Global end of trial date
    30 Apr 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SCOT-2007-01
    Additional study identifiers
    ISRCTN number
    ISRCTN59757862
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Sponsor Ref Number: WN07ON160
    Sponsors
    Sponsor organisation name
    NHS Greater Glasgow and Clyde
    Sponsor organisation address
    Clinical Research and Development Central Office, Dykebar Hospital, Ward 11, Grahamston Road, Paisley, United Kingdom, PA2 7DE
    Public contact
    Dr Margaret Fegen, NHS Greater Glasgow and Clyde, 0141 314 4172, margaret.fegen@ggc.scot.nhs.uk
    Scientific contact
    Dr Margaret Fegen, NHS Greater Glasgow and Clyde, 0141 314 4172, margaret.fegen@ggc.scot.nhs.uk
    Sponsor organisation name
    University of Glasgow
    Sponsor organisation address
    University Avenue, Glasgow, United Kingdom, G12 8QQ
    Public contact
    Dr Debra Stuart, University of Glasgow, 0141 330 4539, debra.stuart@glasgow.ac.uk
    Scientific contact
    Dr Debra Stuart, University of Glasgow, 0141 330 4539, debra.stuart@glasgow.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
    08 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aims to ascertain whether 3 months of treatment for colorectal cancer is as efficacious as 6 months with the further aim of providing robust evidence on the cost effictiveness of reducing the toxicity of adjuvant therapy.
    Protection of trial subjects
    Patients on both study arms received standard chemotherapy agents with standard schedules. The difference is in the duration of treatments - 24 weeks on the standard (control) arm and 12 weeks on the experimental arm. The study therefore posed no risk in terms of increased toxicity for patients as the experimental arm reduced exposure to the chemotherapy. The difference between the study arms was however monitored annually by an IDMC both in terms of toxicity and efficacy,
    Background therapy
    -
    Evidence for comparator
    Colorectal cancer is the fourth most common cancer worldwide, with 1,360,000 cases occurring annually, and is the fifth most common cause of death from cancer, causing 694 000 deaths.(1) Postoperative adjuvant fluoropyrimidine chemotherapy was first shown to improve outcomes for patients with stage III colon cancer by Moertel and colleagues.(2) The addition of oxaliplatin to a fluoropyrimidine chemotherapy backbone produced additional benefit,(3, 4, 5) and oxaliplatin-containing chemotherapy is a recommended adjuvant treatment for stage III colon cancer.(6, 7). The current standard duration of adjuvant chemotherapy for colorectal cancer is 6 months. 1.Ferlay J Soerjomataram I Ervik M et al. GLOBOCAN 2012 v1.0, cancer incidence and mortality worldwide: IARC cancer base no. 11. International Agency for Research on Cancer, Lyon; 2013 2.Moertel CG Fleming TR Macdonald JS et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med. 1990; 322: 352-358 3.Andre T Boni C Mounedji-Boudiaf L et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004; 350: 2343-2351 4.Kuebler JP Wieand HS O'Connell MJ et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007; 25: 2198-2204 5.Haller DG Tabernero J Maroun J et al. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011; 29: 1465-1471 6.Schmoll HJ Van Cutsem E Stein A et al. ESMO Consensus Guidelines for management of patients with colon and rectal cancer. a personalized approach to clinical decision making. Ann Oncol. 2012; 23: 2479-2516 7.National Comprehensive Cancer Network Colon cancer (version 2.2107). http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf (accessed June 24, 2017)
    Actual start date of recruitment
    09 May 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Scientific research
    Long term follow-up duration
    10 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 197
    Country: Number of subjects enrolled
    New Zealand: 16
    Country: Number of subjects enrolled
    Spain: 237
    Country: Number of subjects enrolled
    Sweden: 83
    Country: Number of subjects enrolled
    United Kingdom: 5300
    Country: Number of subjects enrolled
    Denmark: 311
    Worldwide total number of subjects
    6144
    EEA total number of subjects
    5931
    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)
    3340
    From 65 to 84 years
    2804
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were recruited from 244 centres in six countries (the UK, Denmark, Spain, Sweden, Australia, and New Zealand) between March 27, 2008, and Nov 29, 2013

    Pre-assignment
    Screening details
    For a period in the study some UK centres (selected at random) registered patients onto the study before they started treated treatment. Patients were then invited to be randomised at 3 months to continue to 6 months of treatment or stop at that point. 215 were recruited via this route of whom 156 were subsequently randomised.

    Period 1
    Period 1 title
    Trial recruitment (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    12 weeks
    Arm description
    12 weeks of adjuvant flouropyrimidine treatment - either receiving OxMdG (Oxaliplatin and 5-FU) 2 weekly or Xelox (Oxaliplatin and Capecitabine) 3 weekly
    Arm type
    Experimental

    Investigational medicinal product name
    5-FU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-FU 400mg/m2 IV bolus followed by 5-FU 2400mg/m2 IV over 46 hours every 2 weeks

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    130mg/m2 IV on 3 weekly cycle or 85mg/m2 IV on 2 weekly cycle

    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 twice daily for 14 days

    Investigational medicinal product name
    Folinic Acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    L-Folinic acid 175 mg or folinic acid 350 mg 2 weekly

    Arm title
    24 weeks
    Arm description
    24 weeks of adjuvant flouropyrimidine treatment - either receiving OxMdG (Oxaliplatin and 5-FU) 2 weekly or Xelox (Oxaliplatin and Capecitabine) 3 weekly
    Arm type
    Active comparator

    Investigational medicinal product name
    5-FU
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-FU 400mg/m2 IV bolus followed by 5-FU 2400mg/m2 IV over 46 hours every 2 weeks

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    130mg/m2 IV on 3 weekly cycle or 85mg/m2 IV on 2 weekly cycle

    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 twice daily for 14 days on 3 weekly cycle

    Investigational medicinal product name
    Folinic Acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    L-Folinic acid 175 mg or folinic acid 350 mg 2 weekly

    Number of subjects in period 1 [1]
    12 weeks 24 weeks
    Started
    3044
    3044
    Completed
    3044
    3044
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Some randomly selected centres in the UK recruited patients to the study prior to treatment starting and patients were then invited to be randomised after 3 months of treatment. 215 patients were recruited in this way of whom 159 were randomised. All other patients were randomised prior to treatment starting. Only randomised patients were used in the comparison of the study arms in the baseline period, for efficacy end-points and safety. All patients are reported in worldwide recruitment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    12 weeks
    Reporting group description
    12 weeks of adjuvant flouropyrimidine treatment - either receiving OxMdG (Oxaliplatin and 5-FU) 2 weekly or Xelox (Oxaliplatin and Capecitabine) 3 weekly

    Reporting group title
    24 weeks
    Reporting group description
    24 weeks of adjuvant flouropyrimidine treatment - either receiving OxMdG (Oxaliplatin and 5-FU) 2 weekly or Xelox (Oxaliplatin and Capecitabine) 3 weekly

    Reporting group values
    12 weeks 24 weeks Total
    Number of subjects
    3044 3044 6088
    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
    Age at randomisation
    Units: years
        median (inter-quartile range (Q1-Q3))
    65 (58 to 70) 65 (58 to 70) -
    Gender categorical
    Units: Subjects
        Female
    1201 1200 2401
        Male
    1843 1844 3687
    Disease site
    Units: Subjects
        Colon
    2492 2495 4987
        Rectum
    552 549 1101
    Performance status at randomisation
    Units: Subjects
        ECOG - 0
    2190 2144 4334
        ECOG - 1
    854 900 1754
    T-Stage
    Units: Subjects
        T0
    1 3 4
        T1
    92 95 187
        T2
    284 283 567
        T3
    1749 1748 3497
        T4
    917 915 1832
        TX
    1 0 1
    N-Stage
    Units: Subjects
        N0
    559 557 1116
        N1
    1731 1732 3463
        N2
    754 755 1509
    Planned treatment
    Units: Subjects
        FOLFOX
    993 988 1981
        CAPOX
    2051 2056 4107
    Starting dose of capecitabine (if CAPOX planned)
    Units: Subjects
        750mg/m2
    348 349 697
        800mg/m2
    72 78 150
        1000mg/m2
    1369 1370 2739
        NA - FOLFOX
    993 988 1981
        Not recorded
    262 259 521
    High risk stage II
    Units: Subjects
        Yes
    551 545 1096
        No
    2493 2499 4992
    Randomisation timepoint
    Initially a proportion of patients were randomised at 12 weeks either to stop or continue for a further 12 weeks
    Units: Subjects
        12 weeks
    80 79 159
        Baseline
    2964 2965 5929

    End points

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    End points reporting groups
    Reporting group title
    12 weeks
    Reporting group description
    12 weeks of adjuvant flouropyrimidine treatment - either receiving OxMdG (Oxaliplatin and 5-FU) 2 weekly or Xelox (Oxaliplatin and Capecitabine) 3 weekly

    Reporting group title
    24 weeks
    Reporting group description
    24 weeks of adjuvant flouropyrimidine treatment - either receiving OxMdG (Oxaliplatin and 5-FU) 2 weekly or Xelox (Oxaliplatin and Capecitabine) 3 weekly

    Primary: Disease free survival

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    End point title
    Disease free survival
    End point description
    End point type
    Primary
    End point timeframe
    Disease free survival is defined as the time from randomisation (or trial registration for those randomised after 3 months of therapy) to relapse, development of new colorectal primary or death.
    End point values
    12 weeks 24 weeks
    Number of subjects analysed
    3044
    3044
    Units: Percentage disease free at 3 years
        number (confidence interval 95%)
    76.7 (75.1 to 78.2)
    77.1 (75.6 to 78.6)
    Statistical analysis title
    Cox regression
    Statistical analysis description
    Comparison of disease-free survival
    Comparison groups
    12 weeks v 24 weeks
    Number of subjects included in analysis
    6088
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.012 [1]
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.006
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.909
         upper limit
    1.114
    Notes
    [1] - 1-sided non-inferiority p-value from Cox model including terms for study arm and minimisation factors.

    Secondary: Overall survival

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    End point title
    Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Patients were followed up for a maximum of 8 years.
    End point values
    12 weeks 24 weeks
    Number of subjects analysed
    3044
    3044
    Units: Percent alive at 3 years
        number (confidence interval 95%)
    90.0 (88.9 to 91.1)
    89.6 (88.5 to 90.7)
    Statistical analysis title
    Cox regression
    Statistical analysis description
    OS was compared between the study arms using a Cox model incorporating terms for study arm and minimisation factors.
    Comparison groups
    12 weeks v 24 weeks
    Number of subjects included in analysis
    6088
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.035 [2]
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.994
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.964
         upper limit
    1.143
    Notes
    [2] - 1-sided test for non-inferiority for overall survival.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events systematically collected in the first 868 patients
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    NCI CTC AE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Patients with CTC AE assessment on 3 month arm
    Reporting group description
    In the first 868 patients CTC AE data was systematically assessed; 434 on each arm.

    Reporting group title
    Patients with CTC AE assessment on 6 month arm
    Reporting group description
    In the first 868 patients CTC AE data was systematically assessed; 434 on each arm.

    Serious adverse events
    Patients with CTC AE assessment on 3 month arm Patients with CTC AE assessment on 6 month arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    88 / 434 (20.28%)
    121 / 434 (27.88%)
         number of deaths (all causes)
    87
    84
         number of deaths resulting from adverse events
    2
    3
    Nervous system disorders
    Neuropathy - sensory
         subjects affected / exposed
    4 / 434 (0.92%)
    5 / 434 (1.15%)
         occurrences causally related to treatment / all
    4 / 4
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 434 (0.46%)
    2 / 434 (0.46%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    7 / 434 (1.61%)
    10 / 434 (2.30%)
         occurrences causally related to treatment / all
    7 / 7
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Thrombocytopenia
         subjects affected / exposed
    0 / 434 (0.00%)
    2 / 434 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 434 (2.53%)
    6 / 434 (1.38%)
         occurrences causally related to treatment / all
    12 / 12
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain - Other (specify)
         subjects affected / exposed
    8 / 434 (1.84%)
    16 / 434 (3.69%)
         occurrences causally related to treatment / all
    8 / 8
    16 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain - Select
         subjects affected / exposed
    8 / 434 (1.84%)
    10 / 434 (2.30%)
         occurrences causally related to treatment / all
    8 / 8
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 434 (0.23%)
    2 / 434 (0.46%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorexia
         subjects affected / exposed
    3 / 434 (0.69%)
    2 / 434 (0.46%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    32 / 434 (7.37%)
    32 / 434 (7.37%)
         occurrences causally related to treatment / all
    36 / 36
    34 / 34
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Mucositis (clinical exam)
         subjects affected / exposed
    0 / 434 (0.00%)
    3 / 434 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Mucositis (functional/symptomatic)
         subjects affected / exposed
    1 / 434 (0.23%)
    2 / 434 (0.46%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Nausea
         subjects affected / exposed
    15 / 434 (3.46%)
    7 / 434 (1.61%)
         occurrences causally related to treatment / all
    16 / 16
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Taste alteration
         subjects affected / exposed
    1 / 434 (0.23%)
    1 / 434 (0.23%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    22 / 434 (5.07%)
    14 / 434 (3.23%)
         occurrences causally related to treatment / all
    24 / 24
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hand-foot syndrome
         subjects affected / exposed
    1 / 434 (0.23%)
    0 / 434 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 434 (0.23%)
    1 / 434 (0.23%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection-other (specify)
         subjects affected / exposed
    6 / 434 (1.38%)
    6 / 434 (1.38%)
         occurrences causally related to treatment / all
    7 / 7
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Patients with CTC AE assessment on 3 month arm Patients with CTC AE assessment on 6 month arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    420 / 434 (96.77%)
    425 / 434 (97.93%)
    Nervous system disorders
    neuropathy-sensory
         subjects affected / exposed
    386 / 434 (88.94%)
    402 / 434 (92.63%)
         occurrences all number
    1297
    2480
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    148 / 434 (34.10%)
    203 / 434 (46.77%)
         occurrences all number
    419
    894
    Neutropenia
         subjects affected / exposed
    125 / 434 (28.80%)
    192 / 434 (44.24%)
         occurrences all number
    235
    493
    Thrombocytopenia
         subjects affected / exposed
    124 / 434 (28.57%)
    157 / 434 (36.18%)
         occurrences all number
    252
    499
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    358 / 434 (82.49%)
    385 / 434 (88.71%)
         occurrences all number
    1107
    2012
    Insomnia
         subjects affected / exposed
    19 / 434 (4.38%)
    27 / 434 (6.22%)
         occurrences all number
    28
    56
    Pain - Other (specify)
         subjects affected / exposed
    66 / 434 (15.21%)
    77 / 434 (17.74%)
         occurrences all number
    114
    174
    Pain - Select
         subjects affected / exposed
    39 / 434 (8.99%)
    57 / 434 (13.13%)
         occurrences all number
    58
    155
    Eye disorders
    Photophobia
         subjects affected / exposed
    11 / 434 (2.53%)
    26 / 434 (5.99%)
         occurrences all number
    21
    51
    Watery eye
         subjects affected / exposed
    71 / 434 (16.36%)
    100 / 434 (23.04%)
         occurrences all number
    118
    333
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    127 / 434 (29.26%)
    150 / 434 (34.56%)
         occurrences all number
    277
    483
    anorexia
         subjects affected / exposed
    97 / 434 (22.35%)
    153 / 434 (35.25%)
         occurrences all number
    194
    346
    Diarrhoea
         subjects affected / exposed
    286 / 434 (65.90%)
    314 / 434 (72.35%)
         occurrences all number
    720
    1132
    Mucositis (clinical exam)
         subjects affected / exposed
    58 / 434 (13.36%)
    92 / 434 (21.20%)
         occurrences all number
    106
    184
    Mucositis (functional/symptomatic)
         subjects affected / exposed
    131 / 434 (30.18%)
    178 / 434 (41.01%)
         occurrences all number
    283
    477
    Nausea
         subjects affected / exposed
    268 / 434 (61.75%)
    299 / 434 (68.89%)
         occurrences all number
    666
    936
    Taste alteration
         subjects affected / exposed
    181 / 434 (41.71%)
    235 / 434 (54.15%)
         occurrences all number
    460
    869
    Vomiting
         subjects affected / exposed
    104 / 434 (23.96%)
    136 / 434 (31.34%)
         occurrences all number
    156
    248
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    13 / 434 (3.00%)
    23 / 434 (5.30%)
         occurrences all number
    19
    40
    Skin and subcutaneous tissue disorders
    alopecia
         subjects affected / exposed
    69 / 434 (15.90%)
    104 / 434 (23.96%)
         occurrences all number
    141
    336
    Hand and foot syndrome
    Additional description: Side affect of capecitabiine
         subjects affected / exposed
    138 / 434 (31.80%)
    201 / 434 (46.31%)
         occurrences all number
    270
    619
    Rash
         subjects affected / exposed
    53 / 434 (12.21%)
    91 / 434 (20.97%)
         occurrences all number
    88
    211
    Infections and infestations
    Other - specify
    Additional description: Catch-all fro "other" infections
         subjects affected / exposed
    18 / 434 (4.15%)
    28 / 434 (6.45%)
         occurrences all number
    24
    41

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 May 2009
    Amendment Number 4: Protocol amendment to update study objectives, increase the timing from staging of patients to randomisation and subsequent screening investigations, provide clarification around dose banding and body surface area capping, guidance updated for treatment related toxicities, allow use of calcium and magnesium supplements in patients, and numerous administrative changes to provide further clarity around patient and protocol management.
    17 Jul 2009
    Amendment Number 5: Protocol amendment go provide further guidance on allergic reactions to Oxaliplatin and local management of this.
    20 Mar 2012
    Amendment Number 18: Protocol amendment to discontinue the comparison of the upfront/delayed randomisation of patients, provide clarity around schedule of assessments and timing of investigations, provide further clarity around patient eligibility criteria and timings of screening investigations, allow dose banding of Oxaliplatin, Capecitabine and 5-FU, provide more detailed guidance on the management of toxicity, confirm that patients on Capecitabine should not receive concomitant Warfarin and detail interactions with other known drugs, extend the duration of neurotoxicity questionnaire from 1 year to 2 year follow-up, add a section on the translational research sample collection, and general administrative changes throughout.
    20 Dec 2012
    Amendment Number 22: Protocol amendment to extend the recruitment period of the trial and other general administrative changes.
    15 Jan 2014
    Amendment Number 29: Protocol amendment to clarify details around events which are not required to be reported as SAEs in addition to other general administrative changes to the protocol.
    16 Mar 2015
    Amendment Number 31: Protocol amendment to update on the final recruitment figures and dates and extend follow-up duration of existing patient in addition to other general administrative changes.

    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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