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    Clinical Trial Results:
    Preoperative induction chemotherapy in combination with Bevacizumab followed by combined chemoradiotherapy in locally advanced rectal cancer with high risk of recurrence - a phase II pilot study with preoperative administration of Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin) followed by Capecitabine (Xeloda) plus radiotherapy (RTx)

    Summary
    EudraCT number
    		 2010-024354-11
    Trial protocol
    		 AT  
    Global end of trial date
    26 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Aug 2021
    First version publication date
    26 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABCSGR05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01434147
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ABCSG (Austrian Breast & Colorectal Cancer Study Group)
    Sponsor organisation address
    Nußdorfer Platz 8/12, Vienna, Austria, 1190
    Public contact
    Hannes Fohler (Trial Office Director), ABCSG (Austrian Breast & Colorectal Cancer Study Group), +43 1408 92 30, info@abcg.at
    Scientific contact
    Prof. Dietmar Oefner-Velano, ABCSG (Austrian Breast & Colorectal Cancer Study Group), +43 1408 92 30, info@abcg.at
    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
    26 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate feasibility and tolerance of an induction chemotherapy (Capecitabine/Oxaliplatin) in combination with Bevacizumab (Avastin®) followed by combined radiochemotherapy with Capecitabine (Xeloda®) in patients with locally advanced rectal carcinoma
    Protection of trial subjects
    The study specific patient information and informed consent form included language to encourage study participants to reach out to the Study Doctor / Study Team in case they have any questions, concerns or doubts. Section 14 specifically referenced a 24/7 contact person to reach out to and the ICF contained a reference to the local ombudsman / patient advocacy. A dedicated IDMC was established to ensure patient safety throughout the trial.
    Background therapy
    		 Oxaliplatin was administered as part of the induction chemotherapy in a dose of 130 mg/m2 bid, for 3 cycles, on day 1, 22 and 43 (+/- 2 days). Oxaliplatin was no study medication – it was used in this study as non-investigational product (NIMP).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 2011
    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
    Austria: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    14
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment phase for this study was from 11.10.2011 to 27.02.2013. No extended follow up period was done for this study.

    Pre-assignment
    Screening details
    		 A careful check of inclusion and exclusion criteria had to be performed by the Investigators / Site Teams during a pre-defined "screening period". They then completed a "Registration Form" which was sent to ABCSG for registering a new patient on the study and in the eCRF.

    Pre-assignment period milestones
    Number of subjects started
    		 25
    Number of subjects completed
    		 25

    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
    		 Induction chemo + Bevacizumab
    Arm description
    		 Induction chemotherapy (Capecitabine/Oxaliplatin) in combination with Bevacizumab (Avastin) followed by combined radiochemotherapy with Capecitabine (Xeloda)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avastin
    Investigational medicinal product code
    RO487-6646
    Other name
    Bevacizumab
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab (Avastin®), 25mg/ml, a concentrate for solution for infusion. 100 mg or 400 mg vial diluted with 0.9% NaCl to 100 ml. First infusion during 90 minutes, in case of good tolerability the further infusions can be administered during 60 minutes and then 30 minutes. 7.5 mg Bevacizumab/kg body weight every 21 days. Bevacizumab was administered at day 1 (+/- 2 days), 22 (+/- 2 days) and 43 (+/- 2 days). Patients take a dose of 7.5 mg/kg body weight (diluted with NaCl 0.9% to 100ml) of Bevacizumab on day 1 of each cycle.

    Investigational medicinal product name
    Xeloda
    Investigational medicinal product code
    RO009-1978
    Other name
    Capecitabine
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capecitabine (Xeloda®) is an approved treatment and therefore was no study treatment (NIMP). Dosage was calculated according to the respective body surface: 1000 mg/m2/bid p.o.. Patients were administered Capecitabine in the form of tablets according to the following scheme: • day 1 – 14, followed by 1 week off treatment • day 22 – 35 followed by 1 week off treatment • day 43 – 56 followed by 1 week off treatment Capecitabine was taken twice a day with 12 hours between each intake, 30 minutes after a meal.

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Oxaliplatin is an approved treatment and therefore was no study treatment (NIMP). 130mg/m2/d (on d1 of each cycle of 3-weekly treatment cycles), in combination with Bevacizumab and Capecitabine.

    Number of subjects in period 1
    		Induction chemo + Bevacizumab
    Started
    25
    Completed
    19
    Not completed
    6
         Adverse event, non-fatal
    5
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Induction chemo + Bevacizumab
    Reporting group description
    		 Induction chemotherapy (Capecitabine/Oxaliplatin) in combination with Bevacizumab (Avastin) followed by combined radiochemotherapy with Capecitabine (Xeloda)

    Reporting group values
    		 Induction chemo + Bevacizumab Total
    Number of subjects
    		 25 25
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 14 14
        From 65-84 years
    		 11 11
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 62 (24 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 16 16
    ECOG
    ECOG performance status
    Units: Subjects
        Status 0
    		 25 25
    T-stage
    Units: Subjects
        cTis
    		 1 1
        cT3
    		 20 20
        cT4
    		 4 4
    N-stage
    Units: Subjects
        cN0
    		 5 5
        cN1
    		 10 10
        cN2
    		 8 8
        cNx
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Induction chemo + Bevacizumab
    Reporting group description
    		 Induction chemotherapy (Capecitabine/Oxaliplatin) in combination with Bevacizumab (Avastin) followed by combined radiochemotherapy with Capecitabine (Xeloda)

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT analysis set was defined as all patients who started preoperative treatment. Post resection for inconclusive histology showed on one patient no tumour invasion. This patient did not take any doses of Bevacizumab chemotherapy or any other study therapy and was as such, according to protocol, not included in the ITT analysis set.

    Primary: Feasibility - dose modifications - Capecitabine

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    End point title
    		 Feasibility - dose modifications - Capecitabine [1]
    End point description
    For the primary objective feasibility, the number of patients with dose modification, therapy delay, therapy interruption and early end of therapy, as appropriate, was given for the investigational medical product (IMP) Capecitabine . Based on similar studies more than 17% of patients (hence, more than 4 patients from ITT in this study) experiencing therapy breaks or therapy discontinuations were defined as critical.
    End point type
    Primary
    End point timeframe
    After induction chemotherapy
    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: Single arm study based on descriptive analysis only.
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    5
    No statistical analyses for this end point

    Primary: Feasibility - therapy delays - Capecitabine

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    End point title
    		 Feasibility - therapy delays - Capecitabine [2]
    End point description
    For the primary objective feasibility, the number of patients with dose modification, therapy delay, therapy interruption and early end of therapy, as appropriate, was given for the investigational medical product (IMP) Capecitabine. Based on similar studies more than 17% of patients (hence, more than 4 patients from ITT in this study) experiencing therapy breaks or therapy discontinuations were defined as critical.
    End point type
    Primary
    End point timeframe
    After induction chemotherapy
    Notes
    [2] - 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: Single arm study based on descriptive analysis only.
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    10
    No statistical analyses for this end point

    Primary: Feasibility - therapy interruptions - Capecitabine

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    End point title
    		 Feasibility - therapy interruptions - Capecitabine [3]
    End point description
    For the primary objective feasibility, the number of patients with dose modification, therapy delay, therapy interruption and early end of therapy, as appropriate, was given for the investigational medical product (IMP) Capecitabine. Based on similar studies more than 17% of patients (hence, more than 4 patients from ITT in this study) experiencing therapy breaks or therapy discontinuations were defined as critical.
    End point type
    Primary
    End point timeframe
    After induction chemotherapy
    Notes
    [3] - 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: Single arm study based on descriptive analysis only.
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    3
    No statistical analyses for this end point

    Primary: Feasibility - early end of therapy - Capecitabine

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    End point title
    		 Feasibility - early end of therapy - Capecitabine [4]
    End point description
    For the primary objective feasibility, the number of patients with dose modification, therapy delay, therapy interruption and early end of therapy, as appropriate, was given for the investigational medical product (IMP) Capecitabine. Based on similar studies more than 17% of patients (hence, more than 4 patients from ITT in this study) experiencing therapy breaks or therapy discontinuations were defined as critical.
    End point type
    Primary
    End point timeframe
    After induction chemotherapy
    Notes
    [4] - 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: Single arm study based on descriptive analysis only.
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    5
    No statistical analyses for this end point

    Primary: Feasibility - therapy delays - Bevacizumab

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    End point title
    		 Feasibility - therapy delays - Bevacizumab [5]
    End point description
    For the primary objective feasibility, the number of patients with therapy delay, therapy interruption and early end of therapy, as appropriate, was given for the investigational medical product (IMP) Bevacizumab. Based on similar studies more than 17% of patients (hence, more than 4 patients from ITT in this study) experiencing therapy breaks or therapy discontinuations were defined as critical.
    End point type
    Primary
    End point timeframe
    After induction chemotherapy
    Notes
    [5] - 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: Single arm study based on descriptive analysis only.
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    9
    No statistical analyses for this end point

    Primary: Feasibility - therapy interruptions - Bevacizumab

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    End point title
    		 Feasibility - therapy interruptions - Bevacizumab [6]
    End point description
    For the primary objective feasibility, the number of patients with therapy delay, therapy interruption and early end of therapy, as appropriate, was given for the investigational medical product (IMP) Bevacizumab. Based on similar studies more than 17% of patients (hence, more than 4 patients from ITT in this study) experiencing therapy breaks or therapy discontinuations were defined as critical.
    End point type
    Primary
    End point timeframe
    After induction chemotherapy
    Notes
    [6] - 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: Single arm study based on descriptive analysis only.
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    1
    No statistical analyses for this end point

    Primary: Feasibility - early end of therapy - Bevacizumab

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    End point title
    		 Feasibility - early end of therapy - Bevacizumab [7]
    End point description
    For the primary objective feasibility, the number of patients with therapy delay, therapy interruption and early end of therapy, as appropriate, was given for the investigational medical product (IMP) Bevacizumab. Based on similar studies more than 17% of patients (hence, more than 4 patients from ITT in this study) experiencing therapy breaks or therapy discontinuations were defined as critical.
    End point type
    Primary
    End point timeframe
    After induction chemotherapy
    Notes
    [7] - 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: Single arm study based on descriptive analysis only.
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    5
    No statistical analyses for this end point

    Secondary: Response rate - T-stage downstaging

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    End point title
    		 Response rate - T-stage downstaging
    End point description
    For the secondary objective response rate, the number of patients with T-stage downstaging, N-stage downstaging and complete pathologic remission (pCR) was given.
    End point type
    Secondary
    End point timeframe
    After surgery
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    13
    No statistical analyses for this end point

    Secondary: Response rate - N-stage downstaging

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    End point title
    		 Response rate - N-stage downstaging
    End point description
    For the secondary objective response rate, the number of patients with T-stage downstaging, N-stage downstaging and complete pathologic remission (pCR) was given.
    End point type
    Secondary
    End point timeframe
    After surgery
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    10
    No statistical analyses for this end point

    Secondary: Repsonse rate - pCR

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    End point title
    		 Repsonse rate - pCR
    End point description
    For the secondary objective response rate, the number of patients with T-stage downstaging, N-stage downstaging and complete pathologic remission (pCR) was given.
    End point type
    Secondary
    End point timeframe
    After surgery
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    6
    No statistical analyses for this end point

    Secondary: Postoperative morbidity

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    End point title
    		 Postoperative morbidity
    End point description
    For the secondary objective postoperative morbidity, the number of patients with postoperative morbidity according to Accordion was given.
    End point type
    Secondary
    End point timeframe
    At discharge
    End point values
    		 ITT
    Number of subjects analysed
    24
    Units: Subjects
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first administration of study drug until 30 days after last therapy (radiotherapy or capecitabine, whatever is performed or administered later).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Induction chemo + Bevacizumab
    Reporting group description
    		 -

    Serious adverse events
    		 Induction chemo + Bevacizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 24 (58.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombosis
    Additional description: Thrombosis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Arteriosclerosis coronary artery
    Additional description: Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
    Additional description: Febrile neutropenia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Enterocolitis
    Additional description: Enterocolitis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileal perforation
    Additional description: Ileal perforation
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
    Additional description: Ileus
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
    Additional description: Bronchospasm
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laryngospasm
    Additional description: Laryngospasm
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
    Additional description: Angioedema
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure acute
    Additional description: Renal failure acute
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abscess
    Additional description: Abscess
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral candidiasis
    Additional description: Oral candidiasis
         subjects affected / exposed
    1 / 24 (4.17%)
         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
    		 Induction chemo + Bevacizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 24 (100.00%)
    Vascular disorders
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    9 / 24 (37.50%)
         occurrences all number
    9
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Pain
    Additional description: Pain
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Cough
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Investigations
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Infusion related reaction
    Additional description: Infusion related reaction
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Radiation skin injury
    Additional description: Radiation skin injury
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    4
    Nervous system disorders
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Polyneuropathy
    Additional description: Polyneuropathy
         subjects affected / exposed
    10 / 24 (41.67%)
         occurrences all number
    11
    Blood and lymphatic system disorders
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    5
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Defaecation urgency
    Additional description: Defaecation urgency
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    8 / 24 (33.33%)
         occurrences all number
    11
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    9 / 24 (37.50%)
         occurrences all number
    13
    Proctalgia
    Additional description: Proctalgia
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Proctitis
    Additional description: Proctitis
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    7 / 24 (29.17%)
         occurrences all number
    9
    Skin and subcutaneous tissue disorders
    Dry skin
    Additional description: Dry skin
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Palmar-plantar erythrodysaesthesia syndrome
    Additional description: Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    6 / 24 (25.00%)
         occurrences all number
    7
    Renal and urinary disorders
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Infections and infestations
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Nov 2011
    The protocol amendment was due to changes in the Capecitabine dosage scheme.

    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.
    Limitations are the nonrandomized design and the short interval between neoadjuvant treatment and surgery (median=29 days).

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28476845
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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