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NCT00085735 · OUTCOME

Event-free Survival (EFS)

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma · Source last updated 2026-06-09

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

Measure
NUMBER
Unit
probability of 3 year EFS
Interval / dispersion
95% Confidence Interval
Time frame
Assessed at 3 years

What was measured

EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's).

Analysis population: Per protocol only eligible \& evaluable pts are included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.

Groups in this outcome

Low-dose Craniospinal Radiation (LDSCI)

Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)

Standard-dose Craniospinal Radiation (SDCSI)

Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)

Involved Field Radiation (IFRT)

Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).

Posterior Fossa Radiation (PFRT)

Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).

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-dose Craniospinal Radiation (LDSCI)116
Standard-dose Craniospinal Radiation (SDCSI)110
Involved Field Radiation (IFRT)227
Posterior Fossa Radiation (PFRT)237

Reported measurements

LDCSI vs SDCSI

Analysis denominator · Participants

GroupSource count
Low-dose Craniospinal Radiation (LDSCI)116
Standard-dose Craniospinal Radiation (SDCSI)110
Involved Field Radiation (IFRT)0
Posterior Fossa Radiation (PFRT)0
Values in probability of 3 year EFS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low-dose Craniospinal Radiation (LDSCI)76.3Not reported67.984.7Not reported
Standard-dose Craniospinal Radiation (SDCSI)84.9Not reported77.692.2Not reported
IFRT vs PFRT

Analysis denominator · Participants

GroupSource count
Low-dose Craniospinal Radiation (LDSCI)0
Standard-dose Craniospinal Radiation (SDCSI)0
Involved Field Radiation (IFRT)227
Posterior Fossa Radiation (PFRT)237
Values in probability of 3 year EFS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Involved Field Radiation (IFRT)85.8Not reported81.190.5Not reported
Posterior Fossa Radiation (PFRT)85.8Not reported81.190.5Not reported

Source statistical analyses

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

  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    80
    ci Upper Limit
    1.9
    group Description
    The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.
    non Inferiority Type
    NON_INFERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.5
  2. ci Num Sides
    ONE_SIDED
    ci Pct Value
    94
    ci Upper Limit
    1.3
    group Description
    The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Comment
    A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.
    non Inferiority Type
    NON_INFERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.0
Complete source fields
analyses
  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    80
    ci Upper Limit
    1.9
    group Description
    The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.
    non Inferiority Type
    NON_INFERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.5
  2. ci Num Sides
    ONE_SIDED
    ci Pct Value
    94
    ci Upper Limit
    1.3
    group Description
    The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.
    group Ids
    1. OG002
    2. OG003
    non Inferiority Comment
    A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.
    non Inferiority Type
    NON_INFERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    1.0
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        67.9
        upper Limit
        84.7
        value
        76.3
      2. group Id
        OG001
        lower Limit
        77.6
        upper Limit
        92.2
        value
        84.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        116
      2. group Id
        OG001
        value
        110
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    LDCSI vs SDCSI
  2. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        81.1
        upper Limit
        90.5
        value
        85.8
      2. group Id
        OG003
        lower Limit
        81.1
        upper Limit
        90.5
        value
        85.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        227
      4. group Id
        OG003
        value
        237
      units
      Participants
    title
    IFRT vs PFRT
denoms
  1. counts
    1. group Id
      OG000
      value
      116
    2. group Id
      OG001
      value
      110
    3. group Id
      OG002
      value
      227
    4. group Id
      OG003
      value
      237
    units
    Participants
description
EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% confidence intervals (CI's).
dispersion Type
95% Confidence Interval
groups
  1. description
    Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
    id
    OG000
    title
    Low-dose Craniospinal Radiation (LDSCI)
  2. description
    Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
    id
    OG001
    title
    Standard-dose Craniospinal Radiation (SDCSI)
  3. description
    Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
    id
    OG002
    title
    Involved Field Radiation (IFRT)
  4. description
    Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
    id
    OG003
    title
    Posterior Fossa Radiation (PFRT)
param Type
NUMBER
population Description
Per protocol only eligible \& evaluable pts are included. Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.
reporting Status
POSTED
time Frame
Assessed at 3 years
title
Event-free Survival (EFS)
type
PRIMARY
unit Of Measure
probability of 3 year EFS

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