Skip to content
← Full study record

NCT00085735 · FLOW

Participant flow

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma · Source last updated 2026-06-09

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

groups
  1. description
    Patients 3-7 years of age, LDCSI, IFRT
    id
    FG000
    title
    Arm I (3-7 Yrs of Age, LDCSI, IFRT)
  2. description
    Patients 3-7 years of age, LDCSI, PFRT
    id
    FG001
    title
    Arm II (3-7 Yrs of Age, LDCSI, PFRT)
  3. description
    Patients 3-7 years of age, SDCSI, IFRT
    id
    FG002
    title
    Arm III (3-7 Yrs of Age, SDCSI, IFRT)
  4. description
    Patients 3-7 years of age, SDCSI, PFRT
    id
    FG003
    title
    Arm IV (3-7 Yrs of Age, SDCSI, PFRT)
  5. description
    Patients 8-21 years of age, SDCSI, IFRT
    id
    FG004
    title
    Arm V (8-21 Yrs of Age, SDCSI, IFRT)
  6. description
    Patients 8-21 yrs of age, SDCSI, PFRT
    id
    FG005
    title
    Arm VI (8-21 Yrs of Age, SDCSI, PFRT)
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
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        3
      type
      Lack of Efficacy
    3. 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
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        8
      type
      Physician Decision
    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
        0
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        8
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        17
      6. group Id
        FG005
        num Subjects
        8
      type
      Patient ineligible
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        4
      type
      Excess residual disease
    9. 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
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Reason not documented
    10. 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
        0
      type
      Pt transferred to inst w/out study open
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        64
      3. group Id
        FG002
        num Subjects
        63
      4. group Id
        FG003
        num Subjects
        65
      5. group Id
        FG004
        num Subjects
        147
      6. group Id
        FG005
        num Subjects
        146
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        46
      4. group Id
        FG003
        num Subjects
        46
      5. group Id
        FG004
        num Subjects
        105
      6. group Id
        FG005
        num Subjects
        115
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        19
      5. group Id
        FG004
        num Subjects
        42
      6. group Id
        FG005
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients were randomized to receive a smaller volume boost (radiation to tumor bed)(IFRT) or standard volume boost (radiation to the entire posterior fossa) (PFRT).Patients 3-7 years of age were also randomized to receive reduced-dose craniospinal radiation (LDCSI) or standard-dose craniospinal radiation (SDCSI).Patients 8 and older received SDCSI.
recruitment Details
Participants 3-21 years of age were recruited at Children's Oncology Group institutions worldwide and at sites affiliated with the Dutch Childhood Oncology Group. The first patient was enrolled on April 30, 2004 and the last patient was enrolled on January 6, 2014.
Complete source fields
groups
  1. description
    Patients 3-7 years of age, LDCSI, IFRT
    id
    FG000
    title
    Arm I (3-7 Yrs of Age, LDCSI, IFRT)
  2. description
    Patients 3-7 years of age, LDCSI, PFRT
    id
    FG001
    title
    Arm II (3-7 Yrs of Age, LDCSI, PFRT)
  3. description
    Patients 3-7 years of age, SDCSI, IFRT
    id
    FG002
    title
    Arm III (3-7 Yrs of Age, SDCSI, IFRT)
  4. description
    Patients 3-7 years of age, SDCSI, PFRT
    id
    FG003
    title
    Arm IV (3-7 Yrs of Age, SDCSI, PFRT)
  5. description
    Patients 8-21 years of age, SDCSI, IFRT
    id
    FG004
    title
    Arm V (8-21 Yrs of Age, SDCSI, IFRT)
  6. description
    Patients 8-21 yrs of age, SDCSI, PFRT
    id
    FG005
    title
    Arm VI (8-21 Yrs of Age, SDCSI, PFRT)
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
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        3
      type
      Lack of Efficacy
    3. 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
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        8
      type
      Physician Decision
    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
        0
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        8
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        17
      6. group Id
        FG005
        num Subjects
        8
      type
      Patient ineligible
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        4
      type
      Excess residual disease
    9. 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
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Reason not documented
    10. 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
        0
      type
      Pt transferred to inst w/out study open
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        64
      3. group Id
        FG002
        num Subjects
        63
      4. group Id
        FG003
        num Subjects
        65
      5. group Id
        FG004
        num Subjects
        147
      6. group Id
        FG005
        num Subjects
        146
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        46
      4. group Id
        FG003
        num Subjects
        46
      5. group Id
        FG004
        num Subjects
        105
      6. group Id
        FG005
        num Subjects
        115
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        19
      5. group Id
        FG004
        num Subjects
        42
      6. group Id
        FG005
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients were randomized to receive a smaller volume boost (radiation to tumor bed)(IFRT) or standard volume boost (radiation to the entire posterior fossa) (PFRT).Patients 3-7 years of age were also randomized to receive reduced-dose craniospinal radiation (LDCSI) or standard-dose craniospinal radiation (SDCSI).Patients 8 and older received SDCSI.
recruitment Details
Participants 3-21 years of age were recruited at Children's Oncology Group institutions worldwide and at sites affiliated with the Dutch Childhood Oncology Group. The first patient was enrolled on April 30, 2004 and the last patient was enrolled on January 6, 2014.

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

Preserved source evidence · Not medical advice