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NCT00566540 · BASELINE

Baseline characteristics

Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer · Source last updated 2021-11-26

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
      11
    units
    Participants
groups
  1. description
    PREOPERATIVE:Patients receive cisplatin IV over 2 hours three times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod
    id
    BG000
    title
    Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          79
          value
          63
    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
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        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
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      11
    units
    Participants
groups
  1. description
    PREOPERATIVE:Patients receive cisplatin IV over 2 hours three times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod
    id
    BG000
    title
    Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          79
          value
          63
    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
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        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
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice