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NCT00392327 · FLOW

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Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET · Source last updated 2026-06-08

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

groups
  1. description
    Medulloblastoma patients who received regimen A (no carboplatin / no isotretinoin)
    id
    FG000
    title
    Regimen A (Medulloblastoma Patients)
  2. description
    Medulloblastoma patients who received regimen B (carboplatin / no isotretinoin)
    id
    FG001
    title
    Regimen B (Medulloblastoma Patients)
  3. description
    Medulloblastoma patients who received regimen C (no carboplatin / isotretinoin)
    id
    FG002
    title
    Regimen C (Medulloblastoma Patients)
  4. description
    Medulloblastoma patients who received regimen D (carboplatin / isotretinoin)
    id
    FG003
    title
    Regimen D (Medulloblastoma Patients)
  5. description
    SPNET patients who received regimen A (no carboplatin / no isotretinoin)
    id
    FG004
    title
    Regimen A (SPNET Patients)
  6. description
    SPNET patients who received regimen B (carboplatin / no isotretinoin)
    id
    FG005
    title
    Regimen B (SPNET Patients)
  7. description
    SPNET patients who received regimen C (no carboplatin / isotretinoin)
    id
    FG006
    title
    Regimen C (SPNET Patients)
  8. description
    SPNET patients who received regimen D (carboplatin / isotretinoin)
    id
    FG007
    title
    Regimen D (SPNET Patients)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        3
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        3
      type
      Physician Decision
    4. 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
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        5
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        93
      3. group Id
        FG002
        num Subjects
        56
      4. group Id
        FG003
        num Subjects
        58
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        19
      7. group Id
        FG006
        num Subjects
        21
      8. group Id
        FG007
        num Subjects
        22
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        74
      3. group Id
        FG002
        num Subjects
        36
      4. group Id
        FG003
        num Subjects
        42
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        12
      8. group Id
        FG007
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        9
      8. group Id
        FG007
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants received standard therapy consisting of surgery, radiation and chemotherapy. A subset of patients was randomly assigned to receive carboplatin. A second randomization was used to randomly assign patients to receive isotretinoin. Of note, the isotretinoin randomization was stopped early due to futility.
recruitment Details
Patients (Pts) 3-21 yrs were recruited at COG institutions.The first pt was enrolled 5/23/2007, and the last pt was enrolled 4/9/2018.The study was initially open to medulloblastoma and supratentorial primitive neuroectodermal tumor (SPNET) pts, but closed for SPNET pts as of amendment #2.All pts were off treatment at the time of results reporting.
Complete source fields
groups
  1. description
    Medulloblastoma patients who received regimen A (no carboplatin / no isotretinoin)
    id
    FG000
    title
    Regimen A (Medulloblastoma Patients)
  2. description
    Medulloblastoma patients who received regimen B (carboplatin / no isotretinoin)
    id
    FG001
    title
    Regimen B (Medulloblastoma Patients)
  3. description
    Medulloblastoma patients who received regimen C (no carboplatin / isotretinoin)
    id
    FG002
    title
    Regimen C (Medulloblastoma Patients)
  4. description
    Medulloblastoma patients who received regimen D (carboplatin / isotretinoin)
    id
    FG003
    title
    Regimen D (Medulloblastoma Patients)
  5. description
    SPNET patients who received regimen A (no carboplatin / no isotretinoin)
    id
    FG004
    title
    Regimen A (SPNET Patients)
  6. description
    SPNET patients who received regimen B (carboplatin / no isotretinoin)
    id
    FG005
    title
    Regimen B (SPNET Patients)
  7. description
    SPNET patients who received regimen C (no carboplatin / isotretinoin)
    id
    FG006
    title
    Regimen C (SPNET Patients)
  8. description
    SPNET patients who received regimen D (carboplatin / isotretinoin)
    id
    FG007
    title
    Regimen D (SPNET Patients)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        3
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        3
      type
      Physician Decision
    4. 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
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        5
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        93
      3. group Id
        FG002
        num Subjects
        56
      4. group Id
        FG003
        num Subjects
        58
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        19
      7. group Id
        FG006
        num Subjects
        21
      8. group Id
        FG007
        num Subjects
        22
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        74
      3. group Id
        FG002
        num Subjects
        36
      4. group Id
        FG003
        num Subjects
        42
      5. group Id
        FG004
        num Subjects
        20
      6. group Id
        FG005
        num Subjects
        14
      7. group Id
        FG006
        num Subjects
        12
      8. group Id
        FG007
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        9
      8. group Id
        FG007
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants received standard therapy consisting of surgery, radiation and chemotherapy. A subset of patients was randomly assigned to receive carboplatin. A second randomization was used to randomly assign patients to receive isotretinoin. Of note, the isotretinoin randomization was stopped early due to futility.
recruitment Details
Patients (Pts) 3-21 yrs were recruited at COG institutions.The first pt was enrolled 5/23/2007, and the last pt was enrolled 4/9/2018.The study was initially open to medulloblastoma and supratentorial primitive neuroectodermal tumor (SPNET) pts, but closed for SPNET pts as of amendment #2.All pts were off treatment at the time of results reporting.

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

Preserved source evidence · Not medical advice