Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00112918 · BASELINE

Baseline characteristics

Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer · Source last updated 2013-08-27

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
      955
    2. group Id
      BG001
      value
      960
    3. group Id
      BG002
      value
      952
    4. group Id
      BG003
      value
      2867
    units
    Participants
groups
  1. description
    Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only.
    id
    BG000
    title
    FOLFOX4
  2. description
    Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
    id
    BG001
    title
    FOLFOX4 + Bv
  3. description
    Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
    id
    BG002
    title
    XELOX+Bv
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          219
      title
      <40
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          603
        2. group Id
          BG001
          value
          625
        3. group Id
          BG002
          value
          588
        4. group Id
          BG003
          value
          1816
      title
      40-65
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          275
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          296
        4. group Id
          BG003
          value
          832
      title
      >=65
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          425
        2. group Id
          BG001
          value
          473
        3. group Id
          BG002
          value
          432
        4. group Id
          BG003
          value
          1330
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          530
        2. group Id
          BG001
          value
          487
        3. group Id
          BG002
          value
          520
        4. group Id
          BG003
          value
          1537
        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
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          377
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          33
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          791
        2. group Id
          BG001
          value
          813
        3. group Id
          BG002
          value
          795
        4. group Id
          BG003
          value
          2399
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          56
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
population Description
Baseline Measures are based on the Intent-to-Treat - Stage III Disease Patient Population.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      955
    2. group Id
      BG001
      value
      960
    3. group Id
      BG002
      value
      952
    4. group Id
      BG003
      value
      2867
    units
    Participants
groups
  1. description
    Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only.
    id
    BG000
    title
    FOLFOX4
  2. description
    Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
    id
    BG001
    title
    FOLFOX4 + Bv
  3. description
    Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
    id
    BG002
    title
    XELOX+Bv
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          219
      title
      <40
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          603
        2. group Id
          BG001
          value
          625
        3. group Id
          BG002
          value
          588
        4. group Id
          BG003
          value
          1816
      title
      40-65
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          275
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          296
        4. group Id
          BG003
          value
          832
      title
      >=65
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          425
        2. group Id
          BG001
          value
          473
        3. group Id
          BG002
          value
          432
        4. group Id
          BG003
          value
          1330
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          530
        2. group Id
          BG001
          value
          487
        3. group Id
          BG002
          value
          520
        4. group Id
          BG003
          value
          1537
        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
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          377
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          33
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          791
        2. group Id
          BG001
          value
          813
        3. group Id
          BG002
          value
          795
        4. group Id
          BG003
          value
          2399
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          56
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
population Description
Baseline Measures are based on the Intent-to-Treat - Stage III Disease Patient Population.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice