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NCT00304031 · FLOW

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Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma · Source last updated 2020-06-09

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

groups
  1. description
    Concurrent radiation therapy (RT) with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
    id
    FG000
    title
    No Adjuvant TMZ (Not Randomized)
  2. description
    Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
    id
    FG001
    title
    Conventional Adjuvant TMZ
  3. description
    Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
    id
    FG002
    title
    Dose-dense Adjuvant TMZ
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        144
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Ineligible due to insufficient tissue
    2. reasons
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Patient refusal
    4. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician preference
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Toxicity
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other complicating disease
    8. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other, not otherwise specified
    milestones
    1. achievements
      1. comment
        All participants registered to concomitant treatment; randomized after completing this treatment.
        group Id
        FG000
        num Subjects
        1125
      2. comment
        Participants were not randomized to adjuvant TMZ until after completion of concomitant treatment.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Participants were not randomized to adjuvant TMZ until after completion of concomitant treatment.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1125
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Eligible Pre-randomization Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        1120
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Eligible pre-randomization participants with any follow-up data.
      type
      Eligible Pre-randomization Follow-up
    4. achievements
      1. comment
        These participants completed concomitant treatment and met requirements for randomization.
        group Id
        FG000
        num Subjects
        833
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        292
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Concomitant RT+TMZ (Pre-randomization)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      No follow-up collected
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        411
      3. group Id
        FG002
        num Subjects
        422
      comment
      Participants who met requirements after concomitant treatment were randomized to an adjuvant arm.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        411
      3. group Id
        FG002
        num Subjects
        420
      type
      Eligible Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        254
      3. group Id
        FG002
        num Subjects
        262
      comment
      Eligible participants determined to have unmethylated MGMT.
      type
      Unmethylated MGMT Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        122
      3. group Id
        FG002
        num Subjects
        122
      comment
      Eligible participants determined to have methylated MGMT.
      type
      Methylated MGMT Population
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        95
      comment
      Eligible participants who consented to the quality of life study component, offered after 07-12-2007
      type
      Quality of Life Population
    6. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Randomized participants contributing data to results are considered to have completed the study.
        group Id
        FG001
        num Subjects
        411
      3. comment
        Randomized participants contributing data to results are considered to have completed the study.
        group Id
        FG002
        num Subjects
        420
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Randomization to Adjuvant TMZ Arm
pre Assignment Details
Sites were required to submit participant tumor tissue for central histologic review and MGMT (O-6-methylguanine-DNA methyltransferase) status determination in order for registered participants to continue on the study. Of 1173 participants initially registered, 1125 participants met these requirements and started protocol treatment.
Complete source fields
groups
  1. description
    Concurrent radiation therapy (RT) with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
    id
    FG000
    title
    No Adjuvant TMZ (Not Randomized)
  2. description
    Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
    id
    FG001
    title
    Conventional Adjuvant TMZ
  3. description
    Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
    id
    FG002
    title
    Dose-dense Adjuvant TMZ
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        144
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Ineligible due to insufficient tissue
    2. reasons
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Patient refusal
    4. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician preference
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Toxicity
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other complicating disease
    8. reasons
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other, not otherwise specified
    milestones
    1. achievements
      1. comment
        All participants registered to concomitant treatment; randomized after completing this treatment.
        group Id
        FG000
        num Subjects
        1125
      2. comment
        Participants were not randomized to adjuvant TMZ until after completion of concomitant treatment.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Participants were not randomized to adjuvant TMZ until after completion of concomitant treatment.
        group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1125
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Eligible Pre-randomization Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        1120
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Eligible pre-randomization participants with any follow-up data.
      type
      Eligible Pre-randomization Follow-up
    4. achievements
      1. comment
        These participants completed concomitant treatment and met requirements for randomization.
        group Id
        FG000
        num Subjects
        833
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        292
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Concomitant RT+TMZ (Pre-randomization)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      No follow-up collected
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        411
      3. group Id
        FG002
        num Subjects
        422
      comment
      Participants who met requirements after concomitant treatment were randomized to an adjuvant arm.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        411
      3. group Id
        FG002
        num Subjects
        420
      type
      Eligible Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        254
      3. group Id
        FG002
        num Subjects
        262
      comment
      Eligible participants determined to have unmethylated MGMT.
      type
      Unmethylated MGMT Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        122
      3. group Id
        FG002
        num Subjects
        122
      comment
      Eligible participants determined to have methylated MGMT.
      type
      Methylated MGMT Population
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        95
      comment
      Eligible participants who consented to the quality of life study component, offered after 07-12-2007
      type
      Quality of Life Population
    6. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        Randomized participants contributing data to results are considered to have completed the study.
        group Id
        FG001
        num Subjects
        411
      3. comment
        Randomized participants contributing data to results are considered to have completed the study.
        group Id
        FG002
        num Subjects
        420
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Randomization to Adjuvant TMZ Arm
pre Assignment Details
Sites were required to submit participant tumor tissue for central histologic review and MGMT (O-6-methylguanine-DNA methyltransferase) status determination in order for registered participants to continue on the study. Of 1173 participants initially registered, 1125 participants met these requirements and started protocol treatment.

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Preserved source evidence · Not medical advice