NCT00304031 · OUTCOME
Mean Neurocognitive Function (NCF) Composite Score Over 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
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, 10, 22, and 46 weeks
What was measured
The NCF Composite score is the arithmetic mean of the HVLT-R (Free Recall, Delayed Recall, Delayed Recognition), TMTA, TMTB, and COWA scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.
Analysis population: Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with data at baseline and the given time point on each 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 for 6 cycles, up to 12 cycles.
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 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
| Group | Source count |
|---|
| Conventional Adjuvant TMZ | 96 |
|---|
| Dose-dense Adjuvant TMZ | 95 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Conventional Adjuvant TMZ | 80 |
|---|
| Dose-dense Adjuvant TMZ | 85 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Conventional Adjuvant TMZ | -1.2 | Not reported | -1.6 | -0.9 | Not reported |
|---|
| Dose-dense Adjuvant TMZ | -1.5 | Not reported | -1.8 | -1.1 | Not reported |
|---|
Week 10 (Cycle 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Conventional Adjuvant TMZ | 67 |
|---|
| Dose-dense Adjuvant TMZ | 63 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Conventional Adjuvant TMZ | -1.3 | Not reported | -1.7 | -1.0 | Not reported |
|---|
| Dose-dense Adjuvant TMZ | -1.45 | Not reported | -1.9 | -1.0 | Not reported |
|---|
Week 22 (Cycle 4)
Analysis denominator · Participants
| Group | Source count |
|---|
| Conventional Adjuvant TMZ | 39 |
|---|
| Dose-dense Adjuvant TMZ | 35 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Conventional Adjuvant TMZ | -1.1 | Not reported | -1.6 | -0.6 | Not reported |
|---|
| Dose-dense Adjuvant TMZ | -1.3 | Not reported | -2.0 | -0.6 | Not reported |
|---|
Week 46 (Cycle 10)
Analysis denominator · Participants
| Group | Source count |
|---|
| Conventional Adjuvant TMZ | 17 |
|---|
| Dose-dense Adjuvant TMZ | 20 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Conventional Adjuvant TMZ | -1.0 | Not reported | -2.1 | 0.2 | Not reported |
|---|
| Dose-dense Adjuvant TMZ | -1.2 | Not reported | -2.0 | -0.3 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- group Description
- A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2357
- statistical Comment
- Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
- statistical Method
- Mixed Models Analysis
- group Description
- A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0147
- statistical Comment
- Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
- statistical Method
- Mixed Models Analysis
- group Description
- A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT Status is reported here.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.457
- statistical Comment
- Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- group Description
- A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2357
- statistical Comment
- Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
- statistical Method
- Mixed Models Analysis
- group Description
- A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0147
- statistical Comment
- Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
- statistical Method
- Mixed Models Analysis
- group Description
- A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT Status is reported here.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.457
- statistical Comment
- Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.6
- upper Limit
- -0.9
- value
- -1.2
- group Id
- OG001
- lower Limit
- -1.8
- upper Limit
- -1.1
- value
- -1.5
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 85
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.7
- upper Limit
- -1.0
- value
- -1.3
- group Id
- OG001
- lower Limit
- -1.9
- upper Limit
- -1.0
- value
- -1.45
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 63
- units
- Participants
- title
- Week 10 (Cycle 1)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.6
- upper Limit
- -0.6
- value
- -1.1
- group Id
- OG001
- lower Limit
- -2.0
- upper Limit
- -0.6
- value
- -1.3
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 35
- units
- Participants
- title
- Week 22 (Cycle 4)
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.1
- upper Limit
- 0.2
- value
- -1.0
- group Id
- OG001
- lower Limit
- -2.0
- upper Limit
- -0.3
- value
- -1.2
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 20
- units
- Participants
- title
- Week 46 (Cycle 10)
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 95
- units
- Participants
- description
- The NCF Composite score is the arithmetic mean of the HVLT-R (Free Recall, Delayed Recall, Delayed Recognition), TMTA, TMTB, and COWA scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.
- dispersion Type
- 95% Confidence Interval
- groups
- 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 for 6 cycles, up to 12 cycles.
- id
- OG000
- title
- Conventional Adjuvant TMZ
- 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 for 6 cycles, up to 12 cycles.
- id
- OG001
- title
- Dose-dense Adjuvant TMZ
- param Type
- MEAN
- population Description
- Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with data at baseline and the given time point on each arm.
- reporting Status
- POSTED
- time Frame
- Baseline, 10, 22, and 46 weeks
- title
- Mean Neurocognitive Function (NCF) Composite Score Over Time
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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