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NCT00069121 · FLOW

Participant flow

A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer · Source last updated 2020-03-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
    id
    FG000
    title
    5-FU/LV
  2. description
    Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
    id
    FG001
    title
    XELOX
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        286
      2. group Id
        FG001
        num Subjects
        242
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        20
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        63
      2. group Id
        FG001
        num Subjects
        63
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        942
      2. group Id
        FG001
        num Subjects
        944
      type
      STARTED
    2. achievements
      1. comment
        Safety Population
        group Id
        FG000
        num Subjects
        926
      2. comment
        Safety Population
        group Id
        FG001
        num Subjects
        938
      type
      Received Treatment
    3. achievements
      1. comment
        total includes Completed and Alive in follow-up
        group Id
        FG000
        num Subjects
        575
      2. comment
        total includes Completed and Alive in follow-up
        group Id
        FG001
        num Subjects
        619
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        367
      2. group Id
        FG001
        num Subjects
        325
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
    id
    FG000
    title
    5-FU/LV
  2. description
    Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine 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 the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
    id
    FG001
    title
    XELOX
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        286
      2. group Id
        FG001
        num Subjects
        242
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        20
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        63
      2. group Id
        FG001
        num Subjects
        63
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        942
      2. group Id
        FG001
        num Subjects
        944
      type
      STARTED
    2. achievements
      1. comment
        Safety Population
        group Id
        FG000
        num Subjects
        926
      2. comment
        Safety Population
        group Id
        FG001
        num Subjects
        938
      type
      Received Treatment
    3. achievements
      1. comment
        total includes Completed and Alive in follow-up
        group Id
        FG000
        num Subjects
        575
      2. comment
        total includes Completed and Alive in follow-up
        group Id
        FG001
        num Subjects
        619
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        367
      2. group Id
        FG001
        num Subjects
        325
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice