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NCT00112918 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    title
    XELOX+Bv
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1151
      2. group Id
        FG001
        num Subjects
        1155
      3. group Id
        FG002
        num Subjects
        1145
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1126
      2. comment
        Includes two patients from FOLFOX4 who received Bv and were assigned to FOLFOX4+Bv safety analysis
        group Id
        FG001
        num Subjects
        1145
      3. group Id
        FG002
        num Subjects
        1135
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        955
      2. group Id
        FG001
        num Subjects
        960
      3. group Id
        FG002
        num Subjects
        952
      type
      Stage III Disease Population
    4. achievements
      1. comment
        Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)
        group Id
        FG000
        num Subjects
        854
      2. comment
        Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)
        group Id
        FG001
        num Subjects
        810
      3. comment
        Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)
        group Id
        FG002
        num Subjects
        846
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        297
      2. group Id
        FG001
        num Subjects
        345
      3. group Id
        FG002
        num Subjects
        299
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Randomization was stratified according to geographic region and disease stage (high-risk stage II or stage III N1 or stage III N2). The primary analysis population consisted of patients with Stage III disease.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    title
    XELOX+Bv
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1151
      2. group Id
        FG001
        num Subjects
        1155
      3. group Id
        FG002
        num Subjects
        1145
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1126
      2. comment
        Includes two patients from FOLFOX4 who received Bv and were assigned to FOLFOX4+Bv safety analysis
        group Id
        FG001
        num Subjects
        1145
      3. group Id
        FG002
        num Subjects
        1135
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        955
      2. group Id
        FG001
        num Subjects
        960
      3. group Id
        FG002
        num Subjects
        952
      type
      Stage III Disease Population
    4. achievements
      1. comment
        Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)
        group Id
        FG000
        num Subjects
        854
      2. comment
        Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)
        group Id
        FG001
        num Subjects
        810
      3. comment
        Represents patients alive in follow-up at the time of final data cut-off (30 June 2012)
        group Id
        FG002
        num Subjects
        846
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        297
      2. group Id
        FG001
        num Subjects
        345
      3. group Id
        FG002
        num Subjects
        299
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Randomization was stratified according to geographic region and disease stage (high-risk stage II or stage III N1 or stage III N2). The primary analysis population consisted of patients with Stage III disease.

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

Preserved source evidence · Not medical advice