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NCT00602667 · OUTCOME

Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity

Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma · Source last updated 2026-05-19

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

Measure
NUMBER
Unit
Percentage of courses delayed
Interval / dispersion
95% Confidence Interval
Time frame
At completion of consolidation therapy (up to 6 months after on-study date)

What was measured

For the subset of patients with metastatic disease (high-risk group patients), during consolidation, we will calculate the number and proportion of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity. Patients were to received 2 courses of consolidation chemotherapy and then maintenance therapy.

Analysis population: Eligible high-risk group patients who started therapy were included. Course 2 of consolidation and the 1st course of maintenance were used in this analysis and assessed for delays \>7 days due to toxicity. Of the 76 high-risk patients that started induction therapy, 50 started consolidation (with 47 courses included in this analysis).

Groups in this outcome

High-Risk Group

Patients with central nervous system (CNS) metastatic disease

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

Analysis denominator · Participants

GroupSource count
High-Risk Group50

Analysis denominator · courses

GroupSource count
High-Risk Group47

Reported measurements

Source class 1
Values in Percentage of courses delayed · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High-Risk Group2.6Not reported0.58.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        8.5
        value
        2.6
denom Units Selected
courses
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      47
    units
    courses
description
For the subset of patients with metastatic disease (high-risk group patients), during consolidation, we will calculate the number and proportion of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity. Patients were to received 2 courses of consolidation chemotherapy and then maintenance therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with central nervous system (CNS) metastatic disease
    id
    OG000
    title
    High-Risk Group
param Type
NUMBER
population Description
Eligible high-risk group patients who started therapy were included. Course 2 of consolidation and the 1st course of maintenance were used in this analysis and assessed for delays \>7 days due to toxicity. Of the 76 high-risk patients that started induction therapy, 50 started consolidation (with 47 courses included in this analysis).
reporting Status
POSTED
time Frame
At completion of consolidation therapy (up to 6 months after on-study date)
title
Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
type
SECONDARY
type Units Analyzed
courses
unit Of Measure
Percentage of courses delayed

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

Preserved source evidence · Not medical advice