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NCT00045630 · BASELINE

Baseline characteristics

S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium · Source last updated 2013-05-27

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
      74
    units
    Participants
groups
  1. description
    Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
    id
    BG000
    title
    Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          83
          value
          69
    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
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          56
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          55
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          16
        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
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        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
          70
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Missing
    description
    Patients will be graded according to the Zubrod performance status scale. 0: Fully active, able to carry 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 self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of limited self-care, confined to bed or chair more than 50% of waking hours. 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
    param Type
    NUMBER
    title
    Performance Status
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
      title
      T2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      T3
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      T4a
    description
    Primary Tumor (T): TX Primary tumor cannot be assessed, T0 No evidence of primary tumor, Ta Non-invasive papillary carcinoma, Tis Carcinoma in situ: "flat tumor", T1 Tumor invades subepithelial connective tissue, T2 Tumor invades muscle, pT2a Tumor invades superficial muscle (inner half), pT2b Tumor invades deep muscle (outer half), T3 Tumor invades perivesical tissue, pT3a Microscopically, pT3b Macroscopically (extravesical mass), T4 Tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall, T4a Tumor invades prostate, uterus, vagina.
    param Type
    NUMBER
    title
    Clinical T Stage
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      No
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Missing
    param Type
    NUMBER
    title
    Prior Intravesical Therapy
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      74
    units
    Participants
groups
  1. description
    Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
    id
    BG000
    title
    Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          83
          value
          69
    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
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          56
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          55
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          16
        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
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        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
          70
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Missing
    description
    Patients will be graded according to the Zubrod performance status scale. 0: Fully active, able to carry 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 self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of limited self-care, confined to bed or chair more than 50% of waking hours. 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
    param Type
    NUMBER
    title
    Performance Status
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
      title
      T2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      T3
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      T4a
    description
    Primary Tumor (T): TX Primary tumor cannot be assessed, T0 No evidence of primary tumor, Ta Non-invasive papillary carcinoma, Tis Carcinoma in situ: "flat tumor", T1 Tumor invades subepithelial connective tissue, T2 Tumor invades muscle, pT2a Tumor invades superficial muscle (inner half), pT2b Tumor invades deep muscle (outer half), T3 Tumor invades perivesical tissue, pT3a Microscopically, pT3b Macroscopically (extravesical mass), T4 Tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall, T4a Tumor invades prostate, uterus, vagina.
    param Type
    NUMBER
    title
    Clinical T Stage
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      No
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Missing
    param Type
    NUMBER
    title
    Prior Intravesical Therapy
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice