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NCT00027846 · FLOW

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Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma · Source last updated 2019-08-07

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

groups
  1. description
    Patients undergo observation.
    id
    FG000
    title
    GTR1 Differentiated Histology Supratentorial (Group 1)
  2. description
    Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks
    id
    FG001
    title
    Radiation (Group 2)
  3. description
    Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
    id
    FG002
    title
    Sub-Total Resection Any Histology or Location (STR) (Group 3)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        41
      3. group Id
        FG002
        num Subjects
        9
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        7
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        14
      type
      Ineligible for study
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      type
      Entry into another COG therapeutic study
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      type
      Neuraxis dissemination during/after ther
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        287
      3. group Id
        FG002
        num Subjects
        78
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        219
      3. group Id
        FG002
        num Subjects
        41
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        68
      3. group Id
        FG002
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients undergo observation.
    id
    FG000
    title
    GTR1 Differentiated Histology Supratentorial (Group 1)
  2. description
    Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks
    id
    FG001
    title
    Radiation (Group 2)
  3. description
    Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
    id
    FG002
    title
    Sub-Total Resection Any Histology or Location (STR) (Group 3)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        41
      3. group Id
        FG002
        num Subjects
        9
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        7
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        14
      type
      Ineligible for study
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      type
      Entry into another COG therapeutic study
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      type
      Neuraxis dissemination during/after ther
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        287
      3. group Id
        FG002
        num Subjects
        78
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        219
      3. group Id
        FG002
        num Subjects
        41
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        68
      3. group Id
        FG002
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice