Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00304031 · OUTCOME

Median Progression-free Survival Time by MGMT Status

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

Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.

Analysis population: MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm.

Groups in this outcome

Conventional Adjuvant TMZ

Concurrent radiation therapy with concurrent temozolomide (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 TMZ376
Dose-dense Adjuvant TMZ384

Reported measurements

Unmethylated MGMT

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ254
Dose-dense Adjuvant TMZ262
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ5.1Not reported4.35.7Not reported
Dose-dense Adjuvant TMZ6.0Not reported5.56.5Not reported
Methylated MGMT

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ122
Dose-dense Adjuvant TMZ122
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ6.5Not reported4.19.6Not reported
Dose-dense Adjuvant TMZ10.1Not reported7.912.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    Unmethylated MGMT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.15
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    0.88
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    Methylated MGMT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.33
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    Unmethylated MGMT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.15
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    0.88
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    estimate Comment
    Reference level = Conventional adjuvant TMZ
    group Description
    Methylated MGMT
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.33
    p Value Comment
    One-sided significance level = 0.05
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.3
        upper Limit
        5.7
        value
        5.1
      2. group Id
        OG001
        lower Limit
        5.5
        upper Limit
        6.5
        value
        6.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        254
      2. group Id
        OG001
        value
        262
      units
      Participants
    title
    Unmethylated MGMT
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        9.6
        value
        6.5
      2. group Id
        OG001
        lower Limit
        7.9
        upper Limit
        12.4
        value
        10.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        122
      2. group Id
        OG001
        value
        122
      units
      Participants
    title
    Methylated MGMT
denoms
  1. counts
    1. group Id
      OG000
      value
      376
    2. group Id
      OG001
      value
      384
    units
    Participants
description
Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Concurrent radiation therapy with concurrent temozolomide (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
MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm.
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
title
Median Progression-free Survival Time by MGMT Status
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice