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NCT00304031 · OUTCOME

Determination of Impactful Baseline Instruments on Overall Survival

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 or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30 subscales are calculated as the mean of component items, then standardized such that subscale scores range from 0 to 100. A high score for a functional scale represents a healthy level of functioning. Controlled Oral Word Association (COWA) score is the sum of correct responses with a range of 0 to infinity. A higher score indicates better functioning. Hopkins Verbal Learning Test - Revised (HVLT-R) score ranges from 0 to 36 for total recall is 0 to 36, 0 to 12 for delayed recall, and -12 to 12 for recognition. A higher score indicates better functioning.

Analysis population: Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 154/191 have COWA, EORTC QLQ-C30, and HVLT-R baseline assessments (final model covariates)

Groups in this outcome

Both Arms Combined

Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, either \[100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle\] or \[75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle\] for 6 cycles, up to 12 cycles.

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

Analysis denominator · Participants

GroupSource count
Both Arms Combined154

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Both Arms Combined17.5Not reported14.020.9Not reported

Source statistical analyses

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

  1. group Description
    A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. EORTC physical functioning is reported here.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.023
    statistical Method
    Regression, Cox
  2. group Description
    A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized HVLT-R recognition is reported here.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.043
    statistical Method
    Regression, Cox
  3. group Description
    A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized COWA is reported here.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.021
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. group Description
    A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. EORTC physical functioning is reported here.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.023
    statistical Method
    Regression, Cox
  2. group Description
    A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized HVLT-R recognition is reported here.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.043
    statistical Method
    Regression, Cox
  3. group Description
    A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized COWA is reported here.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.021
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.0
        upper Limit
        20.9
        value
        17.5
denoms
  1. counts
    1. group Id
      OG000
      value
      154
    units
    Participants
description
Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30 subscales are calculated as the mean of component items, then standardized such that subscale scores range from 0 to 100. A high score for a functional scale represents a healthy level of functioning. Controlled Oral Word Association (COWA) score is the sum of correct responses with a range of 0 to infinity. A higher score indicates better functioning. Hopkins Verbal Learning Test - Revised (HVLT-R) score ranges from 0 to 36 for total recall is 0 to 36, 0 to 12 for delayed recall, and -12 to 12 for recognition. A higher score indicates better functioning.
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, either \[100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle\] or \[75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle\] for 6 cycles, up to 12 cycles.
    id
    OG000
    title
    Both Arms Combined
param Type
MEDIAN
population Description
Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 154/191 have COWA, EORTC QLQ-C30, and HVLT-R baseline assessments (final model covariates)
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
title
Determination of Impactful Baseline Instruments on Overall Survival
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice