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NCT00789958 · BASELINE

Baseline characteristics

S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct · Source last updated 2018-04-09

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
      79
    units
    Participants
groups
  1. description
    Adjuvant Chemotherapy: Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
    id
    BG000
    title
    Adjuvant Chemotherapy + Chemoradiotherapy
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          26
          upper Limit
          86
          value
          62
    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
          41
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          38
        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
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          66
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          66
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
      title
      Negative (R0)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      Microscopically positive (R1)
    param Type
    NUMBER
    title
    Margin of Resection
    unit Of Measure
    participants
population Description
All eligible and analyzable patients that received protocol treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      79
    units
    Participants
groups
  1. description
    Adjuvant Chemotherapy: Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
    id
    BG000
    title
    Adjuvant Chemotherapy + Chemoradiotherapy
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          26
          upper Limit
          86
          value
          62
    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
          41
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          38
        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
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          66
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          66
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
      title
      Negative (R0)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      Microscopically positive (R1)
    param Type
    NUMBER
    title
    Margin of Resection
    unit Of Measure
    participants
population Description
All eligible and analyzable patients that received protocol treatment.

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Preserved source evidence · Not medical advice