Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00462735 · BASELINE

Baseline characteristics

Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer · Source last updated 2018-03-13

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
      33
    units
    Participants
groups
  1. description
    Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
    id
    BG000
    title
    Advanced Head and Neck Cancer
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          77
          value
          59
    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
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        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
          23
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Hispanic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      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
    Performance score
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      0-1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      ≥2
    description
    The Charlson Comorbidity Index contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality. Higher scores indicating greater comorbidity (patients with a score \> 5 have essentially a 100% risk of dying at one year).
    param Type
    NUMBER
    title
    Charlson comorbidity score
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      None
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Occasional
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Moderate
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Heavy
    param Type
    NUMBER
    title
    Alcohol consumption
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      None
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Cigar, pipe, or betel nut only
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      ≤20 pack-y
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      20.1-40 packk-y
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      >40 pack-y
    param Type
    NUMBER
    title
    Smoking
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Sinonasal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Nasopharynx
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Oropharynx
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Oral cavity
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Salivary gland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Larynx
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Hyopharynx
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Unknown primary
    param Type
    NUMBER
    title
    Primary site
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      33
    units
    Participants
groups
  1. description
    Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
    id
    BG000
    title
    Advanced Head and Neck Cancer
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          77
          value
          59
    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
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        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
          23
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Hispanic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      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
    Performance score
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      0-1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      ≥2
    description
    The Charlson Comorbidity Index contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one. Scores are summed to provide a total score to predict mortality. Higher scores indicating greater comorbidity (patients with a score \> 5 have essentially a 100% risk of dying at one year).
    param Type
    NUMBER
    title
    Charlson comorbidity score
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      None
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Occasional
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Moderate
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Heavy
    param Type
    NUMBER
    title
    Alcohol consumption
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      None
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Cigar, pipe, or betel nut only
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      ≤20 pack-y
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      20.1-40 packk-y
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      >40 pack-y
    param Type
    NUMBER
    title
    Smoking
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Sinonasal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Nasopharynx
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Oropharynx
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Oral cavity
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Salivary gland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Larynx
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Hyopharynx
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Unknown primary
    param Type
    NUMBER
    title
    Primary site
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice