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NCT00027846 · OUTCOME

Local Control and Patterns of Failure

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.

Measure
NUMBER
Unit
Participant
Interval / dispersion
Not reported
Time frame
Up to 5 years after completion of study treatment

What was measured

Documented and analyzed qualitatively and quantitatively.

Analysis population: All eligible patients in the study were included.

Groups in this outcome

GTR1 Differentiated Histology Supratentorial (Group 1)

Patients undergo observation.

Radiation (Group 2)

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

Sub-Total Resection Any Histology or Location (STR) (Group 3)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
GTR1 Differentiated Histology Supratentorial (Group 1)11
Radiation (Group 2)281
Sub-Total Resection Any Histology or Location (STR) (Group 3)64

Reported measurements

Local control
Values in Participant · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GTR1 Differentiated Histology Supratentorial (Group 1)6Not reportedNot reportedNot reportedNot reported
Radiation (Group 2)217Not reportedNot reportedNot reportedNot reported
Sub-Total Resection Any Histology or Location (STR) (Group 3)29Not reportedNot reportedNot reportedNot reported
Pattern of failure local
Values in Participant · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GTR1 Differentiated Histology Supratentorial (Group 1)4Not reportedNot reportedNot reportedNot reported
Radiation (Group 2)57Not reportedNot reportedNot reportedNot reported
Sub-Total Resection Any Histology or Location (STR) (Group 3)31Not reportedNot reportedNot reportedNot reported
Pattern of failure Metastatic
Values in Participant · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GTR1 Differentiated Histology Supratentorial (Group 1)0Not reportedNot reportedNot reportedNot reported
Radiation (Group 2)26Not reportedNot reportedNot reportedNot reported
Sub-Total Resection Any Histology or Location (STR) (Group 3)5Not reportedNot reportedNot reportedNot reported
Pattern of failure local & metastatic
Values in Participant · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GTR1 Differentiated Histology Supratentorial (Group 1)1Not reportedNot reportedNot reportedNot reported
Radiation (Group 2)7Not reportedNot reportedNot reportedNot reported
Sub-Total Resection Any Histology or Location (STR) (Group 3)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        217
      3. group Id
        OG002
        value
        29
    title
    Local control
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        57
      3. group Id
        OG002
        value
        31
    title
    Pattern of failure local
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        5
    title
    Pattern of failure Metastatic
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        4
    title
    Pattern of failure local & metastatic
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      281
    3. group Id
      OG002
      value
      64
    units
    Participants
description
Documented and analyzed qualitatively and quantitatively.
groups
  1. description
    Patients undergo observation.
    id
    OG000
    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
    OG001
    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
    OG002
    title
    Sub-Total Resection Any Histology or Location (STR) (Group 3)
param Type
NUMBER
population Description
All eligible patients in the study were included.
reporting Status
POSTED
time Frame
Up to 5 years after completion of study treatment
title
Local Control and Patterns of Failure
type
SECONDARY
unit Of Measure
Participant

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Preserved source evidence · Not medical advice