TriangleNCT00943826 · OUTCOME
PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)
What was measured
EORTC QLQ-C30: 30 items; 5 functional scales; 9 symptom scales; \& global health status. Most questions used 4-point scale (1:Not at all, 4:Very much), 2 questions used 7-point scale (1:very poor, 7:Excellent). EORTC QLQ-BN20: 20 items rated on a 4 point scale (1:not at all, 4:very much). EORTC QLQ-C30 and BN20 scores were transformed to a 0-100 scale, higher score=better functioning/global health (C30) or more severe symptoms (BN20). Stable HRQoL: change from baseline (BL) within 10 points. Improved HRQoL: an increase from BL \>/=10 points for functioning/global health status, \& decrease of \>/=10 points for symptoms. PFS is reported for participants with Stable/Improved global health; physical, social functioning (C30); motor dysfunction \& communication deficit (BN20). PFS: randomization to PD or death. PD: \>=25% increase in sum of products of longest diameters of index lesions; or progression of existing non-index lesions; or appearance of new lesions; or neurological worsening.
Analysis population: Intent to treat population. Number of Participants Analyzed = overall participants evaluable for this outcome measure; n = participants evaluable for specified category.
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 | Source count |
|---|---|
| Bevacizumab + RT + Temozolomide | 458 |
| Placebo + RT + Temozolomide | 463 |
Reported measurements
Global health status (n=354, 309)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bevacizumab + RT + Temozolomide | 8 | Not reported | 0 | 26 | Not reported |
| Placebo + RT + Temozolomide | 4 | Not reported | 1 | 29 | Not reported |
Physical functioning (n=353, 318)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bevacizumab + RT + Temozolomide | 7 | Not reported | 0 | 27 | Not reported |
| Placebo + RT + Temozolomide | 5 | Not reported | 1 | 29 | Not reported |
Social functioning (n=352, 327)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bevacizumab + RT + Temozolomide | 8 | Not reported | 0 | 26 | Not reported |
| Placebo + RT + Temozolomide | 4 | Not reported | 0 | 27 | Not reported |
Motor dysfunction (n=361, 314)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bevacizumab + RT + Temozolomide | 7 | Not reported | 1 | 27 | Not reported |
| Placebo + RT + Temozolomide | 4 | Not reported | 0 | 26 | Not reported |
Communication deficit (n=365, 329)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bevacizumab + RT + Temozolomide | 8 | Not reported | 0 | 27 | Not reported |
| Placebo + RT + Temozolomide | 4 | Not reported | 1 | 24 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 26
- value
- 8
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 29
- value
- 4
- title
- Global health status (n=354, 309)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 27
- value
- 7
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 29
- value
- 5
- title
- Physical functioning (n=353, 318)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 26
- value
- 8
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 27
- value
- 4
- title
- Social functioning (n=352, 327)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 27
- value
- 7
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 26
- value
- 4
- title
- Motor dysfunction (n=361, 314)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 27
- value
- 8
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 24
- value
- 4
- title
- Communication deficit (n=365, 329)
- denoms
- counts
- group Id
- OG000
- value
- 458
- group Id
- OG001
- value
- 463
- units
- Participants
- description
- EORTC QLQ-C30: 30 items; 5 functional scales; 9 symptom scales; \& global health status. Most questions used 4-point scale (1:Not at all, 4:Very much), 2 questions used 7-point scale (1:very poor, 7:Excellent). EORTC QLQ-BN20: 20 items rated on a 4 point scale (1:not at all, 4:very much). EORTC QLQ-C30 and BN20 scores were transformed to a 0-100 scale, higher score=better functioning/global health (C30) or more severe symptoms (BN20). Stable HRQoL: change from baseline (BL) within 10 points. Improved HRQoL: an increase from BL \>/=10 points for functioning/global health status, \& decrease of \>/=10 points for symptoms. PFS is reported for participants with Stable/Improved global health; physical, social functioning (C30); motor dysfunction \& communication deficit (BN20). PFS: randomization to PD or death. PD: \>=25% increase in sum of products of longest diameters of index lesions; or progression of existing non-index lesions; or appearance of new lesions; or neurological worsening.
- dispersion Type
- Full Range
- groups
- 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
- 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. Number of Participants Analyzed = overall participants evaluable for this outcome measure; n = participants evaluable for specified category.
- reporting Status
- POSTED
- time Frame
- Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)
- title
- PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice