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NCT00602667 · OUTCOME

Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1

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
MEDIAN
Unit
L/h/m^2
Interval / dispersion
Full Range
Time frame
Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose

What was measured

Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis.

Analysis population: Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.

Groups in this outcome

Low-Risk Group

Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma

Intermediate-Risk Group

Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease

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
Low-Risk Group26
Intermediate-Risk Group42
High-Risk Group14

Reported measurements

Source class 1
Values in L/h/m^2 · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Low-Risk Group2.95Not reported2.053.89Not reported
Intermediate-Risk Group2.83Not reported2.235.14Not reported
High-Risk Group2.74Not reported2.234.02Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.05
        upper Limit
        3.89
        value
        2.95
      2. group Id
        OG001
        lower Limit
        2.23
        upper Limit
        5.14
        value
        2.83
      3. group Id
        OG002
        lower Limit
        2.23
        upper Limit
        4.02
        value
        2.74
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      42
    3. group Id
      OG002
      value
      14
    units
    Participants
description
Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis.
dispersion Type
Full Range
groups
  1. description
    Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma
    id
    OG000
    title
    Low-Risk Group
  2. description
    Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
    id
    OG001
    title
    Intermediate-Risk Group
  3. description
    Patients with central nervous system (CNS) metastatic disease
    id
    OG002
    title
    High-Risk Group
param Type
MEDIAN
population Description
Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.
reporting Status
POSTED
time Frame
Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose
title
Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1
type
SECONDARY
unit Of Measure
L/h/m^2

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

Preserved source evidence · Not medical advice