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    Clinical Trial Results:
    Randomized Phase IV Trial to Compare Cetuximab with Concomitant Radiation Therapy with Concomitant Mitomycin-C and 5-FU with Radiation Therapy for Locally Advanced Squamous Cell Carcinomas of The Head and Neck

    Summary
    EudraCT number
    2013-001296-20
    Trial protocol
    AT  
    Global end of trial date
    19 Apr 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Feb 2017
    First version publication date
    19 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MITOCET
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02015650
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Medical University of Innsbruck
    Sponsor organisation address
    Anichstraße 35, Innsbruck, Austria, 6020
    Public contact
    OE Clinical Trial Center, Medical University of Innsbruck, 0043 512900370086, ctc@i-med.ac.at
    Scientific contact
    OE Clinical Trial Center, Medical University of Innsbruck, 0043 512900370086, ctc@i-med.ac.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
    18 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Apr 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to demonstrate that Cetuximab combined with radiation therapy has a higher life quality compared to 5-FU/MMC plus radiation therapy, because of decreased side effects.
    Protection of trial subjects
    Participants - must be between ≥18 and ≤70 years of Age - must have specific laboratory values within a certain Limit e.g. neutrophil Count ≥ 1.5 G/l - must be medically suitable to withstand a course of definitive radiation therapy and concomitant chemotherapy or antibody-therapy - must have a Karnofsky performance status (KPS) of ≥ 70 at the time of screening - must not be pregnant or breastfeeding - must not be particpating actively in another clinical trial
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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)
    0
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The recruitement of cancer patients treated at the investigational centre was referred from other institutions or from the cancer patients presented in the local head and neck tumor board review. A record of the most recent pre-treatment evaluations has been reviewed to determine the suitability of the patient for the trial.

    Pre-assignment
    Screening details
    Day -21/-14: Check of inclusion and exclusion criteria, performing of physical examination, vital signs and laboratory test. Verification of histology, tumor imaging and tumor assessment.

    Period 1
    Period 1 title
    Study phase (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cetuximab
    Arm description
    Cetuximab in combination with radiotherapy
    Arm type
    Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Erbitux
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    minimum of 10 weekly infusions 400 mg/m2 loading dose on week 0; 250 mg/m2 maintenance doses beginning on week 1 - 9

    Arm title
    Mitomycin C and 5-Flourouracil
    Arm description
    Mitomycin-C and 5-Flourouracil in combination with radiotherapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Mitomycin C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    10mg/m² (max. 15 mg/d) day 8 and day 43

    Investigational medicinal product name
    5- Flourouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for prolonged-release suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    in total 1000 mg/m² (max. 1500mg/24h) days 8-12 and days 43–47

    Number of subjects in period 1
    Cetuximab Mitomycin C and 5-Flourouracil
    Started
    2
    2
    Completed
    0
    0
    Not completed
    2
    2
         tumor progression
    -
    1
         Lost to follow-up
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cetuximab
    Reporting group description
    Cetuximab in combination with radiotherapy

    Reporting group title
    Mitomycin C and 5-Flourouracil
    Reporting group description
    Mitomycin-C and 5-Flourouracil in combination with radiotherapy

    Reporting group values
    Cetuximab Mitomycin C and 5-Flourouracil Total
    Number of subjects
    2 2 4
    Age categorical
    In total 70 patients have been planned to be included in the trial, 35 patients for each arm.
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    2 2 4
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    1 0 1
        Male
    1 2 3
    Subject analysis sets

    Subject analysis set title
    Risk and benefit analysis
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Risk of the study have been the known side effects of the products: Mitomycin-C, 5-Fluorouracil, Cetuximab and radiation therapy. These are listed in the particular product description and the description of radiation therapy. Another risk would be that the primary objective cannot be fulfilled. So the patients would have a lower quality of life than expected. Some of the benefits for the Patient would have been a decrease of pain medication and side effects caused by pain medication, a decrease of surgical Intervention, Improving of patients social functioning, social eating, social contact, No interruptions of therapy and Increase of life Quality.

    Subject analysis sets values
    Risk and benefit analysis
    Number of subjects
    4
    Age categorical
    In total 70 patients have been planned to be included in the trial, 35 patients for each arm.
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
    4
        85 years and over
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    1
        Male
    3

    End points

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    End points reporting groups
    Reporting group title
    Cetuximab
    Reporting group description
    Cetuximab in combination with radiotherapy

    Reporting group title
    Mitomycin C and 5-Flourouracil
    Reporting group description
    Mitomycin-C and 5-Flourouracil in combination with radiotherapy

    Subject analysis set title
    Risk and benefit analysis
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Risk of the study have been the known side effects of the products: Mitomycin-C, 5-Fluorouracil, Cetuximab and radiation therapy. These are listed in the particular product description and the description of radiation therapy. Another risk would be that the primary objective cannot be fulfilled. So the patients would have a lower quality of life than expected. Some of the benefits for the Patient would have been a decrease of pain medication and side effects caused by pain medication, a decrease of surgical Intervention, Improving of patients social functioning, social eating, social contact, No interruptions of therapy and Increase of life Quality.

    Primary: Quality of Life

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    End point title
    Quality of Life
    End point description
    End point type
    Primary
    End point timeframe
    evaluation of assessment 5 times during actice Phase and 9 times during Follow-Up
    End point values
    Cetuximab Mitomycin C and 5-Flourouracil
    Number of subjects analysed
    2
    2
    Units: assessment of quality of life
    2
    2
    Statistical analysis title
    Statistics primary endpoint active phase
    Comparison groups
    Cetuximab v Mitomycin C and 5-Flourouracil
    Number of subjects included in analysis
    4
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    = 0.05 [2]
    Method
    Fisher exact
    Confidence interval
    Notes
    [1] - The primary objective of this study is to compare whether a combination therapy with Cetuximab improves patient`s quality of life measured with EORTC QLQ-C30 plus H&N35. The primary objective of this study is to compare whether a combination therapy with Cetuximab reduces toxicity regarding the occurrence of rash and mucositis.
    [2] - The primary analysis population will comprise all randomized patients according to the intention-to-treat principle; a secondary per-protocol analysis will exclude patients with major protocol deviations. Statistical tests will generally be two-sid

    Secondary: Response rate

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    End point title
    Response rate
    End point description
    End point type
    Secondary
    End point timeframe
    No assessment during active Phase, 4 times assessment during Follow-Up phase
    End point values
    Number of subjects analysed
    Units: Recist 1.1
    number (not applicable)
        Recist 1.1
    No statistical analyses for this end point

    Secondary: Differences in locoregional disease control

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    End point title
    Differences in locoregional disease control
    End point description
    End point type
    Secondary
    End point timeframe
    No assessment during active Phase, 4 times assessment during Follow-Up.
    End point values
    Number of subjects analysed
    Units: Recist 1.1
    number (not applicable)
        Recist 1.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From patient inclusion to drop-out respectively permature termination of the study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Cetuximab
    Reporting group description
    Cetuximab in combination with radiotherapy

    Reporting group title
    Mitomycin C and 5-Flourouracil
    Reporting group description
    Mitomycin-C and 5-Flourouracil in combination with radiotherapy

    Serious adverse events
    Cetuximab Mitomycin C and 5-Flourouracil
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    1 / 2 (50.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Febrile neutropenia and thrombocytopenia
    Additional description: Recently diagnosed pancreatic cancer with livermetastases. Patinet recieved chemotherapy with cisplatin. Leucopenia, neutropenia and thrombopenia are caused by chemotherapy.
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tracheal stenosis and laryngeal dyspnoea
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brachial plexopathy
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Reduced appetite
    Additional description: Reduced general condition due to reduced appetite caused by combinated radioimmunotherapy.
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
    Additional description: Expected side effects like dyphagia and increase mucus production seem straining for the patient so that the patient couldn't continue therapy in an ambulant setting.
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Cetuximab Mitomycin C and 5-Flourouracil
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    2 / 2 (100.00%)
    General disorders and administration site conditions
    Fatigue
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Edema face
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anorexia
    Additional description: Grade 1, 2
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Insomnia
    Additional description: Grade 1
         subjects affected / exposed
    2 / 2 (100.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Injury, poisoning and procedural complications
    Dermatitis radiation
    Additional description: Grade 1, 2
         subjects affected / exposed
    2 / 2 (100.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Laryngeal mucositis
    Additional description: Grade 1, 2
         subjects affected / exposed
    2 / 2 (100.00%)
    1 / 2 (50.00%)
         occurrences all number
    6
    1
    Sore throat
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Productive cough
    Additional description: Grade 1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Hoarseness
    Additional description: Grade 1, 2
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    2
    Laryngeal stenosis
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukocytosis
    Additional description: Grade 1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dysgeusia
    Additional description: Grade1, 2
         subjects affected / exposed
    2 / 2 (100.00%)
    1 / 2 (50.00%)
         occurrences all number
    2
    1
    Lethargy
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Dysphagia
    Additional description: Grade 1, 2, 3
         subjects affected / exposed
    2 / 2 (100.00%)
    2 / 2 (100.00%)
         occurrences all number
    3
    4
    Dry mouth
    Additional description: Grades 1, 2, 3
         subjects affected / exposed
    2 / 2 (100.00%)
    1 / 2 (50.00%)
         occurrences all number
    4
    1
    Vomiting
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Constipation
    Additional description: Grade 3
         subjects affected / exposed
    2 / 2 (100.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Gastritis
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Mucositis oral
    Additional description: Grade 1, 2
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    4
    Stomach pain
    Additional description: Grade 1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Gastroesophageal reflux disease
    Additional description: Grade 1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash acneiform
    Additional description: rash face and/or rash body; Grade 1, two and/or 3
         subjects affected / exposed
    2 / 2 (100.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    Erythema PEG placing
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
    Additional description: Grade 1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Grade 1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    2
    Endocrine disorders
    Hyperthyroidism
    Additional description: latent hyperthyreodism, Grade 1
         subjects affected / exposed
    2 / 2 (100.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Hypothyroidism
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Hyperthyroidism with isolated FT4 increase
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypophosphatemia
    Additional description: Grade 1
         subjects affected / exposed
    2 / 2 (100.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Hypomagnesemia
    Additional description: Grade 1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Hyperuricemia
    Additional description: Grade 1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Hyperglycemia
    Additional description: Grade 2
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Hypoalbuminemia
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Paronychia
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
    Additional description: Grade 1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Feb 2015
    Change of inclusion criteria in order to fullfill the recruitment rate

    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.
    low recruitment rate
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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