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NCT00943826 · OUTCOME

Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator

A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma · Source last updated 2017-09-25

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
Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)

What was measured

PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization \[WHO\] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging \[MRI\] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(\>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.

Analysis population: Intent to treat population.

Groups in this outcome

Bevacizumab + RT + Temozolomide

In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m\^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.

Placebo + RT + Temozolomide

In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.

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

Analysis denominator · Participants

GroupSource count
Bevacizumab + RT + Temozolomide458
Placebo + RT + Temozolomide463

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bevacizumab + RT + Temozolomide10.6Not reported10.011.4Not reported
Placebo + RT + Temozolomide6.2Not reported6.07.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.74
    estimate Comment
    Stratified by Region and RPA Class.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    Stratified by Region and Recursive partitioning analysis (RPA) Class
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.74
    estimate Comment
    Stratified by Region and RPA Class.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    Stratified by Region and Recursive partitioning analysis (RPA) Class
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.0
        upper Limit
        11.4
        value
        10.6
      2. group Id
        OG001
        lower Limit
        6.0
        upper Limit
        7.5
        value
        6.2
denoms
  1. counts
    1. group Id
      OG000
      value
      458
    2. group Id
      OG001
      value
      463
    units
    Participants
description
PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization \[WHO\] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging \[MRI\] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(\>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m\^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
    id
    OG000
    title
    Bevacizumab + RT + Temozolomide
  2. description
    In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
    id
    OG001
    title
    Placebo + RT + Temozolomide
param Type
MEDIAN
population Description
Intent to treat population.
reporting Status
POSTED
time Frame
Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)
title
Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice