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NCT00943826 · FLOW

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A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma · Source last updated 2017-09-25

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

groups
  1. description
    In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m\^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
    id
    FG000
    title
    Bevacizumab + RT + Temozolomide
  2. description
    In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
    id
    FG001
    title
    Placebo + RT + Temozolomide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        27
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Refused treatment/Did not cooperate
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative reasons
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        458
      2. group Id
        FG001
        num Subjects
        463
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        452
      2. group Id
        FG001
        num Subjects
        459
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        397
      2. group Id
        FG001
        num Subjects
        421
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Concurrent Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        30
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      type
      Refused treatment/Did not cooperate
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative reasons
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Failure to return
    milestones
    1. achievements
      1. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG000
        num Subjects
        396
      2. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG001
        num Subjects
        370
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        353
      2. group Id
        FG001
        num Subjects
        331
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        39
      type
      NOT COMPLETED
    title
    Maintenance Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        5
      type
      Administrative reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        2
      type
      Refused treatment/ Did not cooperate
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrew Consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Failure to return
    milestones
    1. achievements
      1. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG000
        num Subjects
        269
      2. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG001
        num Subjects
        159
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        204
      2. group Id
        FG001
        num Subjects
        143
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Monotherapy Phase
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        16
      type
      Administrative reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Progression of Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrew Consent
    milestones
    1. achievements
      1. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG000
        num Subjects
        27
      2. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG001
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        20
      type
      NOT COMPLETED
    title
    After Primary Overall Survival Analysis
pre Assignment Details
The primary completion date for co-primary outcome of Progression-Free Survival (PFS) was 31 Mar 2012, whereas, the primary completion date for co-primary outcome of Overall Survival (OS) was 28 Feb 2013. Data for PFS and OS are reported according to these cut-off dates.
Complete source fields
groups
  1. description
    In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m\^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
    id
    FG000
    title
    Bevacizumab + RT + Temozolomide
  2. description
    In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
    id
    FG001
    title
    Placebo + RT + Temozolomide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        27
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Refused treatment/Did not cooperate
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative reasons
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        458
      2. group Id
        FG001
        num Subjects
        463
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        452
      2. group Id
        FG001
        num Subjects
        459
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        397
      2. group Id
        FG001
        num Subjects
        421
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Concurrent Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        30
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      type
      Refused treatment/Did not cooperate
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative reasons
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Failure to return
    milestones
    1. achievements
      1. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG000
        num Subjects
        396
      2. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG001
        num Subjects
        370
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        353
      2. group Id
        FG001
        num Subjects
        331
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        39
      type
      NOT COMPLETED
    title
    Maintenance Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        5
      type
      Administrative reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        2
      type
      Refused treatment/ Did not cooperate
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrew Consent
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Failure to return
    milestones
    1. achievements
      1. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG000
        num Subjects
        269
      2. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG001
        num Subjects
        159
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        204
      2. group Id
        FG001
        num Subjects
        143
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Monotherapy Phase
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        16
      type
      Administrative reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Progression of Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrew Consent
    milestones
    1. achievements
      1. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG000
        num Subjects
        27
      2. comment
        Some who completed previous period had discontinued, progressed, or died prior to this period.
        group Id
        FG001
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        20
      type
      NOT COMPLETED
    title
    After Primary Overall Survival Analysis
pre Assignment Details
The primary completion date for co-primary outcome of Progression-Free Survival (PFS) was 31 Mar 2012, whereas, the primary completion date for co-primary outcome of Overall Survival (OS) was 28 Feb 2013. Data for PFS and OS are reported according to these cut-off dates.

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Preserved source evidence · Not medical advice