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NCT00069095 · FLOW

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A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer · Source last updated 2016-10-06

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

groups
  1. description
    Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG000
    title
    Xelox
  2. description
    Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG001
    title
    Folfox-4
  3. description
    Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \[volume equivalent to 7.5 mg/kg BV\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG002
    title
    Xelox+P
  4. description
    Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG003
    title
    Folfox-4+P
  5. description
    Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG004
    title
    Xelox+BV
  6. description
    Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG005
    title
    Folfox-4+BV
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        4
      type
      Ongoing
    2. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        31
      4. group Id
        FG003
        num Subjects
        45
      5. group Id
        FG004
        num Subjects
        48
      6. group Id
        FG005
        num Subjects
        42
      type
      Admin/Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        99
      2. group Id
        FG001
        num Subjects
        92
      3. group Id
        FG002
        num Subjects
        71
      4. group Id
        FG003
        num Subjects
        72
      5. group Id
        FG004
        num Subjects
        109
      6. group Id
        FG005
        num Subjects
        101
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        8
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      type
      Failure to return
    6. reasons
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        127
      3. group Id
        FG002
        num Subjects
        175
      4. group Id
        FG003
        num Subjects
        154
      5. group Id
        FG004
        num Subjects
        101
      6. group Id
        FG005
        num Subjects
        102
      type
      Insufficient Therapeutic Response
    7. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        31
      5. group Id
        FG004
        num Subjects
        24
      6. group Id
        FG005
        num Subjects
        27
      type
      Refused treatment
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        9
      type
      Withdrew
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Other Violation
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        5
      type
      Violation criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        317
      2. group Id
        FG001
        num Subjects
        317
      3. group Id
        FG002
        num Subjects
        350
      4. group Id
        FG003
        num Subjects
        351
      5. group Id
        FG004
        num Subjects
        350
      6. group Id
        FG005
        num Subjects
        349
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        36
      4. group Id
        FG003
        num Subjects
        31
      5. group Id
        FG004
        num Subjects
        48
      6. group Id
        FG005
        num Subjects
        48
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        295
      2. group Id
        FG001
        num Subjects
        302
      3. group Id
        FG002
        num Subjects
        314
      4. group Id
        FG003
        num Subjects
        320
      5. group Id
        FG004
        num Subjects
        302
      6. group Id
        FG005
        num Subjects
        301
      type
      NOT COMPLETED
    title
    Primary Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        18
      6. group Id
        FG005
        num Subjects
        17
      type
      Missing reason
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Eligible for surgery
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        9
      type
      Insufficient therapeutic response
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Participant refusal/Admin reasons
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant had complete response
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      More than 21 days delay between cycles
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Investigator decision (enough treatment)
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant withdrew consent
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant will start new treatment
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant wanted break from treatment
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant completed treatment
    milestones
    1. achievements
      1. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG000
        num Subjects
        8
      2. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG001
        num Subjects
        13
      3. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG002
        num Subjects
        21
      4. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG003
        num Subjects
        17
      5. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG004
        num Subjects
        36
      6. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG005
        num Subjects
        29
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        36
      6. group Id
        FG005
        num Subjects
        29
      type
      NOT COMPLETED
    title
    Post-study Treatment Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        174
      2. group Id
        FG001
        num Subjects
        206
      3. group Id
        FG002
        num Subjects
        120
      4. group Id
        FG003
        num Subjects
        112
      5. group Id
        FG004
        num Subjects
        92
      6. group Id
        FG005
        num Subjects
        101
      type
      Death
    milestones
    1. achievements
      1. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG000
        num Subjects
        284
      2. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG001
        num Subjects
        299
      3. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG002
        num Subjects
        298
      4. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG003
        num Subjects
        299
      5. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG004
        num Subjects
        278
      6. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG005
        num Subjects
        272
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        93
      3. group Id
        FG002
        num Subjects
        178
      4. group Id
        FG003
        num Subjects
        187
      5. group Id
        FG004
        num Subjects
        186
      6. group Id
        FG005
        num Subjects
        171
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        174
      2. group Id
        FG001
        num Subjects
        206
      3. group Id
        FG002
        num Subjects
        120
      4. group Id
        FG003
        num Subjects
        112
      5. group Id
        FG004
        num Subjects
        92
      6. group Id
        FG005
        num Subjects
        101
      type
      NOT COMPLETED
    title
    Follow-up Phase
pre Assignment Details
A total of 2035 participants were randomized to any one of the treatment groups in the study (634 participants in the initial 2-arm part and 1401 participants in the 2x2 factorial part of the study), but only 2034 received study treatment as 1 participant was enrolled twice in the study at 2 study centers.
recruitment Details
This study was conducted in 32 countries - Australia, Austria, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Mexico, New Zealand, Norway, Panama, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and USA.
Complete source fields
groups
  1. description
    Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG000
    title
    Xelox
  2. description
    Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG001
    title
    Folfox-4
  3. description
    Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \[volume equivalent to 7.5 mg/kg BV\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG002
    title
    Xelox+P
  4. description
    Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG003
    title
    Folfox-4+P
  5. description
    Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG004
    title
    Xelox+BV
  6. description
    Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
    id
    FG005
    title
    Folfox-4+BV
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        4
      type
      Ongoing
    2. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        31
      4. group Id
        FG003
        num Subjects
        45
      5. group Id
        FG004
        num Subjects
        48
      6. group Id
        FG005
        num Subjects
        42
      type
      Admin/Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        99
      2. group Id
        FG001
        num Subjects
        92
      3. group Id
        FG002
        num Subjects
        71
      4. group Id
        FG003
        num Subjects
        72
      5. group Id
        FG004
        num Subjects
        109
      6. group Id
        FG005
        num Subjects
        101
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        8
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      type
      Failure to return
    6. reasons
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        127
      3. group Id
        FG002
        num Subjects
        175
      4. group Id
        FG003
        num Subjects
        154
      5. group Id
        FG004
        num Subjects
        101
      6. group Id
        FG005
        num Subjects
        102
      type
      Insufficient Therapeutic Response
    7. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        31
      5. group Id
        FG004
        num Subjects
        24
      6. group Id
        FG005
        num Subjects
        27
      type
      Refused treatment
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        9
      type
      Withdrew
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Other Violation
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        5
      type
      Violation criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        317
      2. group Id
        FG001
        num Subjects
        317
      3. group Id
        FG002
        num Subjects
        350
      4. group Id
        FG003
        num Subjects
        351
      5. group Id
        FG004
        num Subjects
        350
      6. group Id
        FG005
        num Subjects
        349
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        36
      4. group Id
        FG003
        num Subjects
        31
      5. group Id
        FG004
        num Subjects
        48
      6. group Id
        FG005
        num Subjects
        48
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        295
      2. group Id
        FG001
        num Subjects
        302
      3. group Id
        FG002
        num Subjects
        314
      4. group Id
        FG003
        num Subjects
        320
      5. group Id
        FG004
        num Subjects
        302
      6. group Id
        FG005
        num Subjects
        301
      type
      NOT COMPLETED
    title
    Primary Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        18
      6. group Id
        FG005
        num Subjects
        17
      type
      Missing reason
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Eligible for surgery
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        9
      type
      Insufficient therapeutic response
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Participant refusal/Admin reasons
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant had complete response
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      More than 21 days delay between cycles
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Investigator decision (enough treatment)
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant withdrew consent
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant will start new treatment
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant wanted break from treatment
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Participant completed treatment
    milestones
    1. achievements
      1. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG000
        num Subjects
        8
      2. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG001
        num Subjects
        13
      3. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG002
        num Subjects
        21
      4. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG003
        num Subjects
        17
      5. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG004
        num Subjects
        36
      6. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG005
        num Subjects
        29
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        36
      6. group Id
        FG005
        num Subjects
        29
      type
      NOT COMPLETED
    title
    Post-study Treatment Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        174
      2. group Id
        FG001
        num Subjects
        206
      3. group Id
        FG002
        num Subjects
        120
      4. group Id
        FG003
        num Subjects
        112
      5. group Id
        FG004
        num Subjects
        92
      6. group Id
        FG005
        num Subjects
        101
      type
      Death
    milestones
    1. achievements
      1. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG000
        num Subjects
        284
      2. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG001
        num Subjects
        299
      3. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG002
        num Subjects
        298
      4. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG003
        num Subjects
        299
      5. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG004
        num Subjects
        278
      6. comment
        Participants could enter the follow-up phase even without entering the post-study treatment phase.
        group Id
        FG005
        num Subjects
        272
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        93
      3. group Id
        FG002
        num Subjects
        178
      4. group Id
        FG003
        num Subjects
        187
      5. group Id
        FG004
        num Subjects
        186
      6. group Id
        FG005
        num Subjects
        171
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        174
      2. group Id
        FG001
        num Subjects
        206
      3. group Id
        FG002
        num Subjects
        120
      4. group Id
        FG003
        num Subjects
        112
      5. group Id
        FG004
        num Subjects
        92
      6. group Id
        FG005
        num Subjects
        101
      type
      NOT COMPLETED
    title
    Follow-up Phase
pre Assignment Details
A total of 2035 participants were randomized to any one of the treatment groups in the study (634 participants in the initial 2-arm part and 1401 participants in the 2x2 factorial part of the study), but only 2034 received study treatment as 1 participant was enrolled twice in the study at 2 study centers.
recruitment Details
This study was conducted in 32 countries - Australia, Austria, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Mexico, New Zealand, Norway, Panama, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and USA.

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