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NCT00602667 · OUTCOME

Overall Survival (OS) Compared to Historical Controls

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
Percent probability
Interval / dispersion
95% Confidence Interval
Time frame
1 year after treatment initiation of last patient

What was measured

OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.

Analysis population: Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group.

Groups in this outcome

SJYC07 Low-risk Medulloblastoma Patients

Medulloblastoma patients \<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \[R0\])

SJYC07 Intermediate-risk Medulloblastoma Patients

SJYC07 medulloblastoma patients \<3 years of age, no evidence of metastatic disease (M0), and either R0 resection with any other medullo histology other than histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN) (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \>1 cm\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group

SJYC07 High-risk Medulloblastoma Patients

SJYC07 medulloblastoma patients \<3 years of age with evidence of 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
SJYC07 Low-risk Medulloblastoma Patients23
SJYC07 Intermediate-risk Medulloblastoma Patients32
SJYC07 High-risk Medulloblastoma Patients26

Reported measurements

Source class 1
Values in Percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SJYC07 Low-risk Medulloblastoma Patients100Not reported100100Not reported
SJYC07 Intermediate-risk Medulloblastoma Patients84.4Not reported72.196.7Not reported
SJYC07 High-risk Medulloblastoma Patients61.5Not reported43.979.1Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.22
    group Description
    The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.85
  2. ci Lower Limit
    0.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.79
    group Description
    The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).
    group Ids
    1. OG002
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
Complete source fields
analyses
  1. ci Lower Limit
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.22
    group Description
    The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.85
  2. ci Lower Limit
    0.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.79
    group Description
    The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).
    group Ids
    1. OG002
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        100
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        72.1
        upper Limit
        96.7
        value
        84.4
      3. group Id
        OG002
        lower Limit
        43.9
        upper Limit
        79.1
        value
        61.5
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      32
    3. group Id
      OG002
      value
      26
    units
    Participants
description
OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.
dispersion Type
95% Confidence Interval
groups
  1. description
    Medulloblastoma patients \<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \[R0\])
    id
    OG000
    title
    SJYC07 Low-risk Medulloblastoma Patients
  2. description
    SJYC07 medulloblastoma patients \<3 years of age, no evidence of metastatic disease (M0), and either R0 resection with any other medullo histology other than histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN) (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \>1 cm\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group
    id
    OG001
    title
    SJYC07 Intermediate-risk Medulloblastoma Patients
  3. description
    SJYC07 medulloblastoma patients \<3 years of age with evidence of metastatic disease
    id
    OG002
    title
    SJYC07 High-risk Medulloblastoma Patients
param Type
NUMBER
population Description
Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group.
reporting Status
POSTED
time Frame
1 year after treatment initiation of last patient
title
Overall Survival (OS) Compared to Historical Controls
type
SECONDARY
unit Of Measure
Percent probability

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Preserved source evidence · Not medical advice