Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00027846 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      13
    2. group Id
      BG001
      value
      287
    3. group Id
      BG002
      value
      78
    4. group Id
      BG003
      value
      378
    units
    Participants
groups
  1. description
    Patients undergo observation.
    id
    BG000
    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
    BG001
    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
    BG002
    title
    Sub-Total Resection Any Histology or Location (STR) (Group 3)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          281
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          370
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.49
          upper Limit
          16.71
          value
          10.78
        2. group Id
          BG001
          lower Limit
          1.01
          upper Limit
          21.01
          value
          5.58
        3. group Id
          BG002
          lower Limit
          1.01
          upper Limit
          19.60
          value
          5.18
        4. group Id
          BG003
          lower Limit
          1.01
          upper Limit
          21.01
          value
          5.60
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          219
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          52
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          311
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          39
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          290
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          22
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          37
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
      title
      Netherlands
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          317
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      13
    2. group Id
      BG001
      value
      287
    3. group Id
      BG002
      value
      78
    4. group Id
      BG003
      value
      378
    units
    Participants
groups
  1. description
    Patients undergo observation.
    id
    BG000
    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
    BG001
    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
    BG002
    title
    Sub-Total Resection Any Histology or Location (STR) (Group 3)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          281
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          370
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.49
          upper Limit
          16.71
          value
          10.78
        2. group Id
          BG001
          lower Limit
          1.01
          upper Limit
          21.01
          value
          5.58
        3. group Id
          BG002
          lower Limit
          1.01
          upper Limit
          19.60
          value
          5.18
        4. group Id
          BG003
          lower Limit
          1.01
          upper Limit
          21.01
          value
          5.60
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          219
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          52
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          311
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          39
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          290
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          22
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          37
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
      title
      Netherlands
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          317
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice