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    Clinical Trial Results:
    Preoperative combined radiochemotherapy for patients with newly diagnosed, primary operable and locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum

    Summary
    EudraCT number
    		 2004-002358-72
    Trial protocol
    		 AT  
    Global end of trial date
    19 Dec 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Oct 2021
    First version publication date
    10 Sep 2021
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Adding/updating information for Final Analysis (v1 included Interim Analysis as defined by EudraCT)

    Trial information

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    Trial identification
    Sponsor protocol code
    ABCSG R02 (95)/TAKO 05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00297141
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Roche: ML18560
    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 14089230, info@abcsg.at
    Scientific contact
    Prof. Dietmar Oefner-Velano, ABCSG (Austrian Breast & Colorectal Cancer Study Group), +43 14089230, info@abcsg.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
    19 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)
    Protection of trial subjects
    A Data Monitoring Committee (DMC) was established to obtain Patient Safety. The responsibility of the DMC was to evaluate deviations of medical relevance and safety issues. The DMC decided on whether or not the patient should continue the study treatment due to safety issues. Major protocol deviations include all deviations endangering the basal medical concept of the study jeopardizing the safety of the patient. Minor protocol deviations include all other protocol deviations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Dec 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 7 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 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)
    38
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 8 trial sites participated and had the possibility to recruit patients in this trial in Austria. A total of 60 patients were enrolled between Dec 2004 and Dec 2005.

    Pre-assignment
    Screening details
    		 Time period of max. 21 days for screening (from diagnosis to therapy start) in which inclusion and exclusion criteria were assessed and clinical laboratory tests were performed.

    Pre-assignment period milestones
    Number of subjects started
    		 60
    Number of subjects completed
    		 60

    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
    		 Combined radio chemotherapy
    Arm description
    		 Preoperative Chemoradiation with therapy start within 21 days after MRI. Radiotherapy: 5 x 5 days 1.8 Gy; total dose 45 Gy; Chemotherapy: Capecitabine 825mg/m² bid, on radiotherapy days (week 1-4), Oxaliplatin 50mg/m² iv., d 1, 8, 15, 22.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Xeloda
    Investigational medicinal product code
    RO 09-1978
    Other name
    Capecitabine
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    825 mg/m2/bid, on radiotherapy days (week 1-4)

    Investigational medicinal product name
    Eloxatin
    Investigational medicinal product code
    SR 96669
    Other name
    Oxaliplatin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg/m2 BSA per day (d1, d8, d15, d22)

    Number of subjects in period 1
    		Combined radio chemotherapy
    Started
    60
    Completed
    58
    Not completed
    2
         retrospectively stated ineligible
    1
         Lost to follow-up
    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 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)
    		 38 38
        From 65-84 years
    		 22 22
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 61 (34 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 41 41
    WHO Performance Status
    Units: Subjects
        0 (Zero)
    		 55 55
        1 (One)
    		 5 5
    Tumor differentiation
    Units: Subjects
        G1-2
    		 42 42
        G3
    		 9 9
        not classified
    		 9 9
    Histologic type
    Units: Subjects
        adenocarcinoma
    		 51 51
        mucinous
    		 5 5
        others
    		 4 4
    Tumor stage
    Units: Subjects
        cT2
    		 1 1
        cT3
    		 59 59
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat population (ITT) consisted of all patients who received at least one dose of study medication. All efficacy and safety analyses were performed on this population.

    Subject analysis set title
    Survival
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The survival population consisted of all ITT patients with available long-term follow-up. All survival analyses were performed on this population.

    Subject analysis sets values
    		 ITT Survival
    Number of subjects
    59
    58
    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)
    38
        From 65-84 years
    22
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    61 (34 to 76)
    Gender categorical
    Units: Subjects
        Female
    19
        Male
    40
    WHO Performance Status
    Units: Subjects
        0 (Zero)
    54
        1 (One)
    5
    Tumor differentiation
    Units: Subjects
        G1-2
    41
        G3
    9
        not classified
    9
    Histologic type
    Units: Subjects
        adenocarcinoma
    50
        mucinous
    5
        others
    4
    Tumor stage
    Units: Subjects
        cT2
    0
        cT3
    59

    End points

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    End points reporting groups
    Reporting group title
    Combined radio chemotherapy
    Reporting group description
    		 Preoperative Chemoradiation with therapy start within 21 days after MRI. Radiotherapy: 5 x 5 days 1.8 Gy; total dose 45 Gy; Chemotherapy: Capecitabine 825mg/m² bid, on radiotherapy days (week 1-4), Oxaliplatin 50mg/m² iv., d 1, 8, 15, 22.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat population (ITT) consisted of all patients who received at least one dose of study medication. All efficacy and safety analyses were performed on this population.

    Subject analysis set title
    Survival
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The survival population consisted of all ITT patients with available long-term follow-up. All survival analyses were performed on this population.

    Primary: Tumor down-categorization

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    End point title
    		 Tumor down-categorization [1]
    End point description
    The primary efficacy variable was the rate of tumor down-categorization (defined as a decrease of ≥ 1 point(s)) at the T level. The extent of residual tumor in the resected specimen was classified according to the TNM staging system of the American Joint Committee on Cancer/International Union Against Cancer (AJCC/UICC). In case of a complete pathological response (pCR; i.e., ypT0ypN0M0), an independent pathologist re-evaluated the tumor tissue. All efficacy parameters were analyzed descriptively.
    End point type
    Primary
    End point timeframe
    At the time of final surgery following the preoperative combined radio chemotherapy (chemotherapy: Oxaliplatin, Capecitabine).
    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
    59
    Units: Subjects
    31
    No statistical analyses for this end point

    Other pre-specified: Pathological Complete Response (pCR)

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    End point title
    		 Pathological Complete Response (pCR)
    End point description
    The extent of residual tumor in the resected specimen was classified according to the TNM staging system of the American Joint Committee on Cancer/International Union Against Cancer (AJCC/UICC). In case of a complete pathological response (pCR; i.e., ypT0ypN0M0), an independent pathologist re-evaluated the tumor tissue. All efficacy parameters were analyzed descriptively.
    End point type
    Other pre-specified
    End point timeframe
    At the time of final surgery following the preoperative combined radio chemotherapy (chemotherapy: Oxaliplatin, Capecitabine).
    End point values
    		 ITT
    Number of subjects analysed
    59
    Units: Subjects
    6
    No statistical analyses for this end point

    Other pre-specified: Confirmed Pathological Complete Response (pCR)

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    End point title
    		 Confirmed Pathological Complete Response (pCR)
    End point description
    The extent of residual tumor in the resected specimen was classified according to the TNM staging system of the American Joint Committee on Cancer/International Union Against Cancer (AJCC/UICC). In case of a complete pathological response (pCR; i.e., ypT0ypN0M0), an independent pathologist re-evaluated the tumor tissue. All efficacy parameters were analyzed descriptively.
    End point type
    Other pre-specified
    End point timeframe
    At the time of final surgery following the preoperative combined radio chemotherapy (chemotherapy: Oxaliplatin, Capecitabine).
    End point values
    		 ITT
    Number of subjects analysed
    59
    Units: Subjects
    4
    No statistical analyses for this end point

    Other pre-specified: Tumor status

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    End point title
    		 Tumor status
    End point description
    The extent of residual tumor in the resected specimen was classified according to the TNM staging system of the American Joint Committee on Cancer/International Union Against Cancer (AJCC/UICC). In case of a complete pathological response (pCR; i.e., ypT0ypN0M0), an independent pathologist re-evaluated the tumor tissue. All efficacy parameters were analyzed descriptively.
    End point type
    Other pre-specified
    End point timeframe
    At the time of final surgery following the preoperative combined radio chemotherapy (chemotherapy: Oxaliplatin, Capecitabine).
    End point values
    		 ITT
    Number of subjects analysed
    59
    Units: Subjects
        0 (Zero)
    6
        1 (One)
    2
        2 (Two)
    23
        3 (Three)
    26
        4 (Four)
    2
    No statistical analyses for this end point

    Other pre-specified: Nodal status

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    End point title
    		 Nodal status
    End point description
    The extent of residual tumor in the resected specimen was classified according to the TNM staging system of the American Joint Committee on Cancer/International Union Against Cancer (AJCC/UICC). In case of a complete pathological response (pCR; i.e., ypT0ypN0M0), an independent pathologist re-evaluated the tumor tissue. All efficacy parameters were analyzed descriptively.
    End point type
    Other pre-specified
    End point timeframe
    At the time of final surgery following the preoperative combined radio chemotherapy (chemotherapy: Oxaliplatin, Capecitabine).
    End point values
    		 ITT
    Number of subjects analysed
    59
    Units: Subjects
        0 (Zero)
    43
        1 (One)
    10
        2 (Two)
    6
    No statistical analyses for this end point

    Other pre-specified: Metastasis

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    End point title
    		 Metastasis
    End point description
    The extent of residual tumor in the resected specimen was classified according to the TNM staging system of the American Joint Committee on Cancer/International Union Against Cancer (AJCC/UICC). In case of a complete pathological response (pCR; i.e., ypT0ypN0M0), an independent pathologist re-evaluated the tumor tissue. All efficacy parameters were analyzed descriptively.
    End point type
    Other pre-specified
    End point timeframe
    At the time of final surgery following the preoperative combined radio chemotherapy (chemotherapy: Oxaliplatin, Capecitabine).
    End point values
    		 ITT
    Number of subjects analysed
    59
    Units: Subjects
        0 (Zero)
    59
        1 (One)
    0
    No statistical analyses for this end point

    Other pre-specified: Relapse-free survival

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    End point title
    		 Relapse-free survival
    End point description
    Relapse-free survival was defined as the interval between surgery and the first evidence of locoregional recurrence, distant metastasis or death from any cause. Patients without relapse or death were right-censored at the last date when they were known to be alive (date of their last assessment). 5-year survival estimates (%) for relapse-free survival were presented based on Kaplan-Meier method.
    End point type
    Other pre-specified
    End point timeframe
    During follow-up
    End point values
    		 Combined radio chemotherapy Survival
    Number of subjects analysed
    58
    58
    Units: percent
        number (not applicable)
    65.5
    65.5
    Statistical analysis title
    		 Tumor down-categorization
    Statistical analysis description
    Relapse-free survival was compared for patients with different chemotherapy response (without vs. with tumor down-categorization) at surgery. Comparison was done using Log-rank test with two-sided p-values. Hazard ratios (HRs) and their corresponding 95% confidence intervals (CIs) were estimated by Cox proportional hazards regression.
    Comparison groups
    Combined radio chemotherapy v Survival
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.0478 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 6.03
    Notes
    [2] - Subjects in analysis actually are 58 - but the number of subjects was counted twice due to the necessary workaround for single arm studies given by EudraCT to accomodate reporting of statistical analysis.
    [3] - Cox p=0.0556
    Statistical analysis title
    		 Pathological Complete Response (pCR)
    Statistical analysis description
    Relapse-free survival was compared for patients with different chemotherapy response (without vs. with pCR) at surgery. Comparison was done using Log-rank test with two-sided p-values. Hazard ratios (HRs) and their corresponding 95% confidence intervals (CIs) were estimated by Cox proportional hazards regression.
    Comparison groups
    Combined radio chemotherapy v Survival
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.2591 [5]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 22.4
    Notes
    [4] - Subjects in analysis actually are 58 - but the number of subjects was counted twice due to the necessary workaround for single arm studies given by EudraCT to accomodate reporting of statistical analysis.
    [5] - Cox p=0.2833
    Statistical analysis title
    		 Nodal status
    Statistical analysis description
    Relapse free survival was compared for patients with different nodal status (yPN+ vs yPN-) at surgery. Comparison was done using Log-rank test with two-sided p-values. Hazard ratios (HRs) and their corresponding 95% confidence intervals (CIs) were estimated by Cox proportional hazards regression.
    Comparison groups
    Combined radio chemotherapy v Survival
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 < 0.0001 [7]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    8.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.29
         upper limit
    		 20.12
    Notes
    [6] - Subjects in analysis actually are 58 - but the number of subjects was counted twice due to the necessary workaround for single arm studies given by EudraCT to accomodate reporting of statistical analysis.
    [7] - Cox p<0.0001

    Other pre-specified: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival was defined as the interval between surgery and death from any cause. Patients without death were right-censored at the last date when they were known to be alive (date of their last assessment). 5-year survival estimates (%) for overall survival were presented based on Kaplan-Meier method.
    End point type
    Other pre-specified
    End point timeframe
    During follow-up
    End point values
    		 Combined radio chemotherapy Survival
    Number of subjects analysed
    58
    58
    Units: percent
        number (not applicable)
    74.4
    74.4
    Statistical analysis title
    		 Tumor down-categorization
    Statistical analysis description
    Overall survival was compared for patients with different chemotherapy response (without vs. with tumor down-categorization) at surgery. Comparison was done using Log-rank test with two-sided p-values. Hazard ratios (HRs) and their corresponding 95% confidence intervals (CIs) were estimated by Cox proportional hazards regression.
    Comparison groups
    Combined radio chemotherapy v Survival
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.3246 [9]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 4.26
    Notes
    [8] - Subjects in analysis actually are 58 - but the number of subjects was counted twice due to the necessary workaround for single arm studies given by EudraCT to accomodate reporting of statistical analysis.
    [9] - Cox p=0.3292
    Statistical analysis title
    		 Pathological Complete Response (pCR)
    Statistical analysis description
    Overall survival was compared for patients with different chemotherapy response (without vs. with pCR) at surgery. Comparison was done using Log-rank test with two-sided p-values. Hazard ratios (HRs) and their corresponding 95% confidence intervals (CIs) were estimated by Cox proportional hazards regression.
    Comparison groups
    Combined radio chemotherapy v Survival
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 = 0.4318 [11]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 16.63
    Notes
    [10] - Subjects in analysis actually are 58 - but the number of subjects was counted twice due to the necessary workaround for single arm studies given by EudraCT to accomodate reporting of statistical analysis.
    [11] - Cox p=0.4437
    Statistical analysis title
    		 Nodal status
    Statistical analysis description
    Overall survival was compared for patients with different nodal status (yPN+ vs yPN-) at surgery. Comparison was done using Log-rank test with two-sided p-values. Hazard ratios (HRs) and their corresponding 95% confidence intervals (CIs) were estimated by Cox proportional hazards regression.
    Comparison groups
    Combined radio chemotherapy v Survival
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 < 0.0001 [13]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.36
         upper limit
    		 17.85
    Notes
    [12] - Subjects in analysis actually are 58 - but the number of subjects was counted twice due to the necessary workaround for single arm studies given by EudraCT to accomodate reporting of statistical analysis.
    [13] - Cox p<0.0001

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first administration of radiochemotherapy until surgery
    Adverse event reporting additional description
    Adverse events were reported until the Interim Analysis (according to EudraCT definition) only - no adverse events were captured during follow-up and hence, there is no update on adverse events for the Final Analysis (according to EudraCT definition).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Combined radiochemotherapy
    Reporting group description
    		 -

    Serious adverse events
    		 Combined radiochemotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 59 (20.34%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences causally related to treatment / all
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    5 / 59 (8.47%)
         occurrences causally related to treatment / all
    12 / 13
         deaths causally related to treatment / all
    0 / 0
    Proctitis
    Additional description: Proctitis
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    1 / 59 (1.69%)
         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
    		 Combined radiochemotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 59 (94.92%)
    Injury, poisoning and procedural complications
    Radiation skin injury
    Additional description: Radiation skin injury
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences all number
    8
    Vascular disorders
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    5 / 59 (8.47%)
         occurrences all number
    13
    Nervous system disorders
    Neurotoxicity
    Additional description: Neurotoxicity
         subjects affected / exposed
    22 / 59 (37.29%)
         occurrences all number
    57
    Blood and lymphatic system disorders
    Leukopenia
    Additional description: Leukopenia
         subjects affected / exposed
    7 / 59 (11.86%)
         occurrences all number
    17
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    4 / 59 (6.78%)
         occurrences all number
    10
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    7 / 59 (11.86%)
         occurrences all number
    9
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    7 / 59 (11.86%)
         occurrences all number
    8
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences all number
    6
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    6 / 59 (10.17%)
         occurrences all number
    11
    Gastrointestinal toxicity
    Additional description: Gastrointestinal toxicity
         subjects affected / exposed
    8 / 59 (13.56%)
         occurrences all number
    8
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    26 / 59 (44.07%)
         occurrences all number
    69
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    19 / 59 (32.20%)
         occurrences all number
    37
    Painful defaecation
    Additional description: Painful defaecation
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences all number
    11
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    5 / 59 (8.47%)
         occurrences all number
    6
    Skin and subcutaneous tissue disorders
    Skin toxicity
    Additional description: Skin toxicity
         subjects affected / exposed
    7 / 59 (11.86%)
         occurrences all number
    11
    Psychiatric disorders
    Mental disorder
    Additional description: Mental disorder
         subjects affected / exposed
    4 / 59 (6.78%)
         occurrences all number
    4
    Renal and urinary disorders
    Micturition urgency
    Additional description: Micturition urgency
         subjects affected / exposed
    5 / 59 (8.47%)
         occurrences all number
    8
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    6 / 59 (10.17%)
         occurrences all number
    16
    Infections and infestations
    Infection
    Additional description: Infection
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    Weight fluctuation
    Additional description: Weight fluctuation
         subjects affected / exposed
    12 / 59 (20.34%)
         occurrences all number
    21

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Apr 2010
    According to Protocol Amendment #1, collection of prolonged (after surgery) follow up survival data was done. This data should enable estimation of survival curves for overall survival, cancer specific survival and relapse-free survival. Additionally, relationship between study primary endpoints tumor stage downstaging and yPCR and survival endpoints was examined. It should be stated that study was not powered for comparison between chemotherapy response and survival endpoint.

    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.
    Limitation of a nonrandomized design.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29127435
    For support, Contact us.
    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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