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NCT00626990 · OUTCOME

Progression-free Survival

Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH) · Source last updated 2023-09-11

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 till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study)

What was measured

Disease progression is defined as radiological or neurological/clinical progression (whichever occurs first); progression free survival (PFS) is the time interval between the date of randomization and the date of disease progression or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination. Radiological progression was defined as increase of contrast enhancing area on MRI or CT scans of more than 25% as measured by two perpendicular diameters compared to the smallest measurements ever recorded for the same lesion by the same technique. The appearance of new lesions with or without contrast enhancement Neurological/clinical progression was defined as:decrease in WHO performance status,deterioration of neurological functions,appearance of signs/symptoms of increased intracranial pressure,and/or start of corticosteroid or increase of corticosteroid dosage by 50% for control of neurological symptoms.

Analysis population: This trial studied separately two questions 1) effect of concomitant TMZ 2) effect of adjuvant TMZ. The 4 randomized arms were combined before analysis. Absence of concomitant TMZ including Arm RT alone \& Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT \& Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone \& Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ \& Arm TMZ/RT followed by adjuvant TMZ

Groups in this outcome

Absence of Concomitant TMZ

Including 2 randomized arms: Arm RT alone and Arm RT followed by adjuvant TMZ

Presence of Concomitant TMZ

Including 2 randomized arms: Arm TMZ/RT and Arm TMZ/RT followed by adjuvant TMZ

Absence of Adjuvant TMZ

Including two randomized arms: Arm RT alone and Arm TMZ/RT

Presence of Adjuvant TMZ

Including to 2 randomized arms: Arm RT followed by adjuvant TMZ and Arm TMZ/RT followed by adjuvant TMZ

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

Analysis denominator · Participants

GroupSource count
Absence of Concomitant TMZ375
Presence of Concomitant TMZ376
Absence of Adjuvant TMZ377
Presence of Adjuvant TMZ374

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Absence of Concomitant TMZ20.9Not reported17.2526.64Not reported
Presence of Concomitant TMZ33.02Not reported23.8246.06Not reported
Absence of Adjuvant TMZ19.09Not reported14.5923.82Not reported
Presence of Adjuvant TMZ42.81Not reported27.8356.44Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.11
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.70
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.59
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.11
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.70
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.59
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.25
        upper Limit
        26.64
        value
        20.9
      2. group Id
        OG001
        lower Limit
        23.82
        upper Limit
        46.06
        value
        33.02
      3. group Id
        OG002
        lower Limit
        14.59
        upper Limit
        23.82
        value
        19.09
      4. group Id
        OG003
        lower Limit
        27.83
        upper Limit
        56.44
        value
        42.81
denoms
  1. counts
    1. group Id
      OG000
      value
      375
    2. group Id
      OG001
      value
      376
    3. group Id
      OG002
      value
      377
    4. group Id
      OG003
      value
      374
    units
    Participants
description
Disease progression is defined as radiological or neurological/clinical progression (whichever occurs first); progression free survival (PFS) is the time interval between the date of randomization and the date of disease progression or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination. Radiological progression was defined as increase of contrast enhancing area on MRI or CT scans of more than 25% as measured by two perpendicular diameters compared to the smallest measurements ever recorded for the same lesion by the same technique. The appearance of new lesions with or without contrast enhancement Neurological/clinical progression was defined as:decrease in WHO performance status,deterioration of neurological functions,appearance of signs/symptoms of increased intracranial pressure,and/or start of corticosteroid or increase of corticosteroid dosage by 50% for control of neurological symptoms.
dispersion Type
95% Confidence Interval
groups
  1. description
    Including 2 randomized arms: Arm RT alone and Arm RT followed by adjuvant TMZ
    id
    OG000
    title
    Absence of Concomitant TMZ
  2. description
    Including 2 randomized arms: Arm TMZ/RT and Arm TMZ/RT followed by adjuvant TMZ
    id
    OG001
    title
    Presence of Concomitant TMZ
  3. description
    Including two randomized arms: Arm RT alone and Arm TMZ/RT
    id
    OG002
    title
    Absence of Adjuvant TMZ
  4. description
    Including to 2 randomized arms: Arm RT followed by adjuvant TMZ and Arm TMZ/RT followed by adjuvant TMZ
    id
    OG003
    title
    Presence of Adjuvant TMZ
param Type
MEDIAN
population Description
This trial studied separately two questions 1) effect of concomitant TMZ 2) effect of adjuvant TMZ. The 4 randomized arms were combined before analysis. Absence of concomitant TMZ including Arm RT alone \& Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT \& Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone \& Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ \& Arm TMZ/RT followed by adjuvant TMZ
reporting Status
POSTED
time Frame
from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study)
title
Progression-free Survival
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice