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NCT00304031 · OUTCOME

Median Overall Survival Time

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma · Source last updated 2020-06-09

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

What was measured

Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis occurred after 647 deaths were reported.

Analysis population: Randomized eligible patients.

Groups in this outcome

Conventional Adjuvant TMZ

Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.

Dose-dense Adjuvant TMZ

Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ411
Dose-dense Adjuvant TMZ420

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ16.6Not reported14.918.0Not reported
Dose-dense Adjuvant TMZ14.9Not reported13.716.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    This study was looking for a 20% reduction in hazard rate: null hypothesis (conventional arm): Median survival time (MST) = 14.0 mo.; alternative hypothesis (dose-dense arm): MST= 17.5 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 750 patients (647 deaths were required for the final analysis).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.63
    p Value Comment
    One-sided
    param Type
    Hazard Ratio (HR)
    param Value
    1.03
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    This study was looking for a 20% reduction in hazard rate: null hypothesis (conventional arm): Median survival time (MST) = 14.0 mo.; alternative hypothesis (dose-dense arm): MST= 17.5 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 750 patients (647 deaths were required for the final analysis).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.63
    p Value Comment
    One-sided
    param Type
    Hazard Ratio (HR)
    param Value
    1.03
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.9
        upper Limit
        18.0
        value
        16.6
      2. group Id
        OG001
        lower Limit
        13.7
        upper Limit
        16.5
        value
        14.9
denoms
  1. counts
    1. group Id
      OG000
      value
      411
    2. group Id
      OG001
      value
      420
    units
    Participants
description
Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis occurred after 647 deaths were reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
    id
    OG000
    title
    Conventional Adjuvant TMZ
  2. description
    Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
    id
    OG001
    title
    Dose-dense Adjuvant TMZ
param Type
MEDIAN
population Description
Randomized eligible patients.
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
title
Median Overall Survival Time
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice