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NCT01096368 · FLOW

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Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma · Source last updated 2026-04-30

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

groups
  1. description
    Patients with classic histology (WHO Grade II) supratentorial ependymoma who have undergone microscopic gross total resection (GTR1) or achieved CR either after first or second resection or after post-operative induction chemotherapy are assigned to observation. For patients without GTR1, induction chemotherapy is comprised of vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Arm I: Observation
  2. description
    Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma who have undergone gross or near total resection (GTR or NTR) or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy. Maintenance chemotherapy comprised of vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.
    id
    FG001
    title
    Arm II: Randomized to Radiation With Maintenance Chemotherapy
  3. description
    Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) who have undergone gross or near total resection or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation.
    id
    FG002
    title
    Arm III: Randomized to Radiation Only
  4. description
    Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment.
    id
    FG003
    title
    Arm IV: Nonrandomly Assigned to Arm II Treatment
  5. description
    Patients with tumor other than ependymoma or withdrew before protocol-specified radiotherapy administered
    id
    FG004
    title
    Not Ependymoma or Withdrew Before Radiation
periods
  1. drop Withdraws
    1. 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
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        6
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        52
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        14
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        25
      type
      Ineligible
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Did not start treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        3
      type
      Progressive disease
    7. 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
      type
      Other
    8. 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
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Treated with institutional review
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        163
      4. group Id
        FG003
        num Subjects
        63
      5. group Id
        FG004
        num Subjects
        49
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        88
      3. group Id
        FG002
        num Subjects
        154
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        79
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        24
      5. group Id
        FG004
        num Subjects
        49
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients with classic histology (WHO Grade II) supratentorial ependymoma who have undergone microscopic gross total resection (GTR1) or achieved CR either after first or second resection or after post-operative induction chemotherapy are assigned to observation. For patients without GTR1, induction chemotherapy is comprised of vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Arm I: Observation
  2. description
    Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma who have undergone gross or near total resection (GTR or NTR) or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy. Maintenance chemotherapy comprised of vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.
    id
    FG001
    title
    Arm II: Randomized to Radiation With Maintenance Chemotherapy
  3. description
    Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) who have undergone gross or near total resection or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation.
    id
    FG002
    title
    Arm III: Randomized to Radiation Only
  4. description
    Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment.
    id
    FG003
    title
    Arm IV: Nonrandomly Assigned to Arm II Treatment
  5. description
    Patients with tumor other than ependymoma or withdrew before protocol-specified radiotherapy administered
    id
    FG004
    title
    Not Ependymoma or Withdrew Before Radiation
periods
  1. drop Withdraws
    1. 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
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        6
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        52
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        14
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        25
      type
      Ineligible
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Did not start treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        3
      type
      Progressive disease
    7. 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
      type
      Other
    8. 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
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Treated with institutional review
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        167
      3. group Id
        FG002
        num Subjects
        163
      4. group Id
        FG003
        num Subjects
        63
      5. group Id
        FG004
        num Subjects
        49
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        88
      3. group Id
        FG002
        num Subjects
        154
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        79
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        24
      5. group Id
        FG004
        num Subjects
        49
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice