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NCT00027846 · OUTCOME

Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy

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
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
At the time of second surgery

What was measured

The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.

Analysis population: Of 64 eligible patients in this group, 25 patients after chemotherapy had the second surgery. Of 25 patients with second surgery after chemotherapy, 19 had a Gross-Total or Near-Total resection. 19/25=76%.

Groups in this outcome

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
Sub-Total Resection Any Histology or Location (STR) (Group 3)25

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sub-Total Resection Any Histology or Location (STR) (Group 3)76Not reported54.990.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.9
        upper Limit
        90.6
        value
        76
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Sub-Total Resection Any Histology or Location (STR) (Group 3)
param Type
NUMBER
population Description
Of 64 eligible patients in this group, 25 patients after chemotherapy had the second surgery. Of 25 patients with second surgery after chemotherapy, 19 had a Gross-Total or Near-Total resection. 19/25=76%.
reporting Status
POSTED
time Frame
At the time of second surgery
title
Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice