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NCT00970502 · BASELINE

Baseline characteristics

Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer · Source last updated 2017-04-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      14
    units
    Participants
groups
  1. description
    erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
    id
    BG000
    title
    Erlotinib + Celecoxib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          43
          upper Limit
          93
          value
          64
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      2
    description
    The Eastern Cooperative Oncology Group (ECOG) 0 - Fully active, able to carry on all pre-disease performance without restriction 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
    param Type
    NUMBER
    title
    ECOG Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      None to minimal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      <20
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      20-40
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      >40
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    param Type
    NUMBER
    title
    Tobacco use, pack-years
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Primary recurrence
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Second or later recurrence
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Second primary cancer
    param Type
    NUMBER
    title
    Recurrent vs secondary primary
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Squamous cell carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Adenoid cystic
    param Type
    NUMBER
    title
    Histology
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Sinonasal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Ear/facial skin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Oropharynx
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Oral cavity
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Hypopharynx
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Larynx
    param Type
    NUMBER
    title
    Primary Site
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Tx-T3
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      T4
    description
    T4 --\> Tumor of any size with direct extension to chest wall or skin Tx - T3 --\> any tumor not classified as T4
    param Type
    NUMBER
    title
    Primary tumor classification
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      N0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      N1
    description
    N0 - tumor cells absent from regional lymph nodes N1 - regional lymph node metastasis present; (at some sites; tumor spread to closest or small number of regional lymph nodes)
    param Type
    NUMBER
    title
    Lymph node status
    unit Of Measure
    participants
population Description
15 subjects consented, one withdrew before receiving study treatment and was excluded from analysis
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      14
    units
    Participants
groups
  1. description
    erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
    id
    BG000
    title
    Erlotinib + Celecoxib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          43
          upper Limit
          93
          value
          64
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      2
    description
    The Eastern Cooperative Oncology Group (ECOG) 0 - Fully active, able to carry on all pre-disease performance without restriction 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
    param Type
    NUMBER
    title
    ECOG Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      None to minimal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      <20
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      20-40
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      >40
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    param Type
    NUMBER
    title
    Tobacco use, pack-years
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Primary recurrence
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Second or later recurrence
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Second primary cancer
    param Type
    NUMBER
    title
    Recurrent vs secondary primary
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Squamous cell carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Adenoid cystic
    param Type
    NUMBER
    title
    Histology
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Sinonasal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Ear/facial skin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Oropharynx
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Oral cavity
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Hypopharynx
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Larynx
    param Type
    NUMBER
    title
    Primary Site
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Tx-T3
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      T4
    description
    T4 --\> Tumor of any size with direct extension to chest wall or skin Tx - T3 --\> any tumor not classified as T4
    param Type
    NUMBER
    title
    Primary tumor classification
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      N0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      N1
    description
    N0 - tumor cells absent from regional lymph nodes N1 - regional lymph node metastasis present; (at some sites; tumor spread to closest or small number of regional lymph nodes)
    param Type
    NUMBER
    title
    Lymph node status
    unit Of Measure
    participants
population Description
15 subjects consented, one withdrew before receiving study treatment and was excluded from analysis

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Preserved source evidence · Not medical advice