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NCT01185171 · BASELINE

Baseline characteristics

Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer · Source last updated 2023-05-11

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
      69
    units
    Participants
groups
  1. description
    Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone. Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
    id
    BG000
    title
    ZD1839 500mg by Mouth (po) Daily
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          64
          value
          55
    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
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          55
        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
          58
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Hispanic
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      69
    units
    Participants
groups
  1. description
    Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone. Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
    id
    BG000
    title
    ZD1839 500mg by Mouth (po) Daily
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          64
          value
          55
    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
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          55
        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
          58
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Hispanic
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice