Trial Outcomes & Findings for Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme (NCT NCT02120287)
NCT ID: NCT02120287
Last Updated: 2019-05-07
Results Overview
The number of months that a patient remains alive from the day first gamma knife surgery until the date of death or end of data collection for survival.
COMPLETED
PHASE2
16 participants
Up to 2 years
2019-05-07
Participant Flow
Participant milestones
| Measure |
BZ-SRS With Bevacizumab
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
BZ-SRS With Bevacizumab
n=16 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Age, Continuous
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62 years
n=5 Participants
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Sex: Female, Male
Female
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11 Participants
n=5 Participants
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Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The number of months that a patient remains alive from the day first gamma knife surgery until the date of death or end of data collection for survival.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=16 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Overall Survival (OS)
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11.73 months
Interval 8.64 to 26.05
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SECONDARY outcome
Timeframe: At 6 monthsPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The proportion of patients who did not experience disease progression per RANO as of 6 months from the date of radiosurgery. RANO (Response Assessment in Neuro-Oncology) Response Criteria for Progression using imaging features: 25% or more increase in enhancing lesions despite stable or increasing steroid dose increase (significant) in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes any new lesions clinical features clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). Proportion of patients for PFS = number of patients without disease at 6 months post radiosurgery / total number of patients.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=16 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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6-month Progression-free Survival
Death or disease progression ≤ 6mons of treatment
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0.438 proportion of participants
Interval 0.198 to 0.701
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6-month Progression-free Survival
Alive or stable disease ≥ 6 months of treatment
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0.562 proportion of participants
Interval 0.299 to 0.802
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SECONDARY outcome
Timeframe: At 6 monthsPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The proportion of patients who remained alive as of 6 months from the date of radiosurgery. Proportion of patients for OS = number of patients alive at 6 months post radiosurgery / total number of patients.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=16 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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6-month Overall Survival
Death within 6 months of treatment
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0.0625 proportion of participants
Interval 0.0158 to 0.302
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6-month Overall Survival
Alive after 6 months of treatment
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0.938 proportion of participants
Interval 0.698 to 0.998
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SECONDARY outcome
Timeframe: Six months after SRSPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The number of patients experiencing a CNS toxicity type occurring within 3 months of gamma knife surgery, as measured by RTOG/EORTC Acute Radiation Morbidity Scoring and the NCI CTCAE v4.0 for late toxicity.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=16 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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CNS Toxicity
Muscle Weakness Lower Limb
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1 number of participants
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CNS Toxicity
Fatigue and Dehydration
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1 number of participants
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CNS Toxicity
Spinal Fracture and Pain
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1 number of participants
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SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
Proportion of patients with a best response of CR, PR, SD, PD: number of patients with CR, PR, SD or PD / total number of patients evaluable for response to treatment of border zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=16 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Tumor Response
Complete Response
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0.077 Proportion of participants
Interval 0.0019 to 0.36
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Tumor Response
Partial Response
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0.308 Proportion of participants
Interval 0.091 to 0.614
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Tumor Response
Stable Disease
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0.538 Proportion of participants
Interval 0.251 to 0.808
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Tumor Response
Progressed Disease
|
0.077 Proportion of participants
Interval 0.0019 to 0.36
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SECONDARY outcome
Timeframe: Prior to radiosurgeryPopulation: Participants who received MRS (Magnetic Resonance Spectroscopy) scans prior to radiosurgery.
Improvement of border zone target selection and detection of therapeutic response of the derived treatment volumes between MRI and MRI+MRS (Magnetic Resonance Spectroscopy). This is presented as the number of patients for whom the derived treatment was changed as a result of the utilization of MRS.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=11 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Potential Value of Magnetic Resonance Spectroscopy (MRS)
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0 number of participants
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SECONDARY outcome
Timeframe: At baseline (Week 0) prior to treatment administrationPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. Score range from 0 to 100; the lower the Karnofsky score, the worse the survival for most serious illnesses. A score of 100 would indicate 'Normal no complaints; no evidence of disease.' A score of 50 indicates 'Requires considerable assistance and frequent medical care.' A score of 0-10 would indicate 'Moribund; fatal processes progressing rapidly' and 'Death'.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=16 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Karnofsky Performance Status
Karnofsky Performance Status Score: 70
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4 participants
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|
Karnofsky Performance Status
Karnofsky Performance Status Score: 40
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0 participants
|
|
Karnofsky Performance Status
Karnofsky Performance Status Score: 60
|
0 participants
|
|
Karnofsky Performance Status
Karnofsky Performance Status Score: 80
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6 participants
|
|
Karnofsky Performance Status
Karnofsky Performance Status Score: 90
|
6 participants
|
|
Karnofsky Performance Status
Karnofsky Performance Status Score: 100
|
0 participants
|
SECONDARY outcome
Timeframe: At baseline (Week 0) prior to treatment administrationPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The Barthel Index consists items assessing the ability to achieve certain activities without assistance. It evaluates the ability of feeding, moving from wheelchair to bed and returning, doing personal toilet, getting on and off toilet,bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. Scoring ranged from 0 (completely dependent) to 20 (completely independent) for this assessment. A maximal score of 20 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=13 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Barthel's Index of Activities of Daily Living Assessment
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17.77 score on a scale
Interval 10.98 to 24.55
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SECONDARY outcome
Timeframe: At 8 weeksPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The Barthel Index consists items assessing the ability to achieve certain activities without assistance. It evaluates the ability of feeding, moving from wheelchair to bed and returning, doing personal toilet, getting on and off toilet,bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. Scoring ranged from 0 (completely dependent) to 20 (completely independent) for this assessment. A maximal score of 20 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=10 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Barthel's Index of Activities of Daily Living Assessment
|
16.30 score on a scale
Interval 5.16 to 27.44
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SECONDARY outcome
Timeframe: At baseline (Week 0) prior to treatment administrationPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
An assessment comprised of 20 statements for which the participant is asked to indicate how often they have felt a certain way during the past week. SCORING: zero for answers of Rarely or none of the time (less than 1 day), 1 for answers of Some or a little of the time (1-2 days), 2 for answers of Occasionally or a moderate amount of time (3-4 days) the third column, 3 for answers of Most or all of the time (5-7 days). The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more depression symptomatology.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=13 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Center for Epidemiological Studies Depression Scale (CES-D)
|
17.0 score on a scale
Interval 10.5 to 23.5
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SECONDARY outcome
Timeframe: At 8 weeksPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
An assessment comprised of 20 statements for which the participant is asked to indicate how often they have felt a certain way during the past week. SCORING: zero for answers of Rarely or none of the time (less than 1 day), 1 for answers of Some or a little of the time (1-2 days), 2 for answers of Occasionally or a moderate amount of time (3-4 days) the third column, 3 for answers of Most or all of the time (5-7 days). The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more depression symptomatology.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=9 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Center for Epidemiological Studies Depression Scale (CES-D)
|
20.2 score on a scale
Interval 12.2 to 28.3
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SECONDARY outcome
Timeframe: At baseline (Week 0) prior to treatment administrationPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg). (NOTE: One participant did not complete the EWB section of the questionnaire. One participant did not complete the FWB section of the questionnaire.)
The FACT-G is a patient rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=14 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Functional Assessment of Cancer - General (FACT-G)
Physical Well-Being
|
18.9 score on a scale
Interval 14.9 to 22.8
|
|
Functional Assessment of Cancer - General (FACT-G)
Social Well-Being
|
23.6 score on a scale
Interval 22.0 to 25.3
|
|
Functional Assessment of Cancer - General (FACT-G)
Emotional Well-Being
|
15.8 score on a scale
Interval 12.4 to 19.3
|
|
Functional Assessment of Cancer - General (FACT-G)
Functional Well-Being
|
16.8 score on a scale
Interval 12.6 to 20.9
|
|
Functional Assessment of Cancer - General (FACT-G)
Total Well-Being
|
75.8 score on a scale
Interval 64.3 to 87.3
|
SECONDARY outcome
Timeframe: At 8 weeksPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The FACT-G is a patient rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=10 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
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Functional Assessment of Cancer Therapy-General - General (FACT-G)
Physical Well-Being
|
20.0 score on a scale
Interval 17.3 to 22.7
|
|
Functional Assessment of Cancer Therapy-General - General (FACT-G)
Social Well-Being
|
23.1 score on a scale
Interval 20.9 to 25.3
|
|
Functional Assessment of Cancer Therapy-General - General (FACT-G)
Emotional Well-Being
|
16.4 score on a scale
Interval 12.9 to 19.9
|
|
Functional Assessment of Cancer Therapy-General - General (FACT-G)
Functional Well-Being
|
15.8 score on a scale
Interval 10.3 to 21.3
|
|
Functional Assessment of Cancer Therapy-General - General (FACT-G)
Total Well-Being
|
75.3 score on a scale
Interval 65.7 to 84.9
|
SECONDARY outcome
Timeframe: At baseline (Week 0) prior to treatment administrationPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The FACT-BrSI subscale, brain tumor specific version (2007), is a 15-item, patient completed, questionnaire.This brain subscale is used along with the core (general) questionnaire (FACT-G) that includes 27 items. Patients rate all items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher quality of life (QOL). The FACT BrSI has a range of 0-60, where a higher score indicates less symptomatology.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=14 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
|
|---|---|
|
Functional Assessment of Cancer Therapy-Brain Specific Symptom Index (FACT-BrSI)
|
39.7 score on a scale
Interval 32.5 to 47.0
|
SECONDARY outcome
Timeframe: At 8 weeksPopulation: Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).
The FACT-BrSI subscale, brain tumor specific version (2007), is a 15-item, patient completed, questionnaire.This brain subscale is used along with the core (general) questionnaire (FACT-G) that includes 27 items. Patients rate all items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher quality of life (QOL). The FACT BrSI has a range of 0-60, where a higher score indicates less symptomatology.
Outcome measures
| Measure |
BZ-SRS With Bevacizumab
n=10 Participants
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
|
|---|---|
|
Functional Assessment of Cancer Therapy-Brain Specific Symptom Index (FACT-BrSI)
|
40.5 score on a scale
Interval 37.1 to 43.9
|
Adverse Events
BZ-SRS With Bevacizumab
Serious adverse events
| Measure |
BZ-SRS With Bevacizumab
n=16 participants at risk
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
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|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • 2 years
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • 2 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
6.2%
1/16 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.2%
1/16 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.2%
1/16 • 2 years
|
|
Nervous system disorders
Cognitive disturbance
|
6.2%
1/16 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Nervous system disorders
Seizure
|
25.0%
4/16 • 2 years
|
|
Psychiatric disorders
Confusion
|
18.8%
3/16 • 2 years
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • 2 years
|
|
Psychiatric disorders
Suicidal ideation
|
6.2%
1/16 • 2 years
|
Other adverse events
| Measure |
BZ-SRS With Bevacizumab
n=16 participants at risk
All patients received Border Zone Stereotactic Radiosurgery (BZ-SRS) and additionally received bevacizumab (10 mg/kg) one day before and then at day 14 followed by 10 mg/kg/day every 14 days until disease progression. One to 14 days before BZ- SRS procedure, patients at centers with MRS experience will undergo standard brain MRI /MRS. Patients will have MRS Magnetic Resonance Spectroscopy (MRS)prior to BZ-SRS. Border Zone Stereotactic Radiosurgery (BZ-SRS): The 'border zone' of the tumor will be targeted by SRS in a single session.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
6.2%
1/16 • 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.2%
1/16 • 2 years
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • 2 years
|
|
Eye disorders
Eye disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
6/16 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • 2 years
|
|
General disorders
Chills
|
6.2%
1/16 • 2 years
|
|
General disorders
Edema limbs
|
6.2%
1/16 • 2 years
|
|
General disorders
Fatigue
|
68.8%
11/16 • 2 years
|
|
General disorders
Gait disturbance
|
12.5%
2/16 • 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.2%
1/16 • 2 years
|
|
General disorders
Pain
|
31.2%
5/16 • 2 years
|
|
Infections and infestations
Mucosal infection
|
6.2%
1/16 • 2 years
|
|
Infections and infestations
Sinusitis
|
18.8%
3/16 • 2 years
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
18.8%
3/16 • 2 years
|
|
Injury, poisoning and procedural complications
Intraoperative musculoskeletal injury
|
6.2%
1/16 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
2/16 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • 2 years
|
|
Investigations
Cholesterol high
|
12.5%
2/16 • 2 years
|
|
Investigations
Investigations - Other, specify
|
12.5%
2/16 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
6.2%
1/16 • 2 years
|
|
Investigations
Platelet count decreased
|
25.0%
4/16 • 2 years
|
|
Investigations
White blood cell decreased
|
6.2%
1/16 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
18.8%
3/16 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.2%
1/16 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
2/16 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.8%
3/16 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
2/16 • 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
4/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
1/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
6.2%
1/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
2/16 • 2 years
|
|
Nervous system disorders
Cognitive disturbance
|
25.0%
4/16 • 2 years
|
|
Nervous system disorders
Dysarthria
|
12.5%
2/16 • 2 years
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
12.5%
2/16 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.2%
1/16 • 2 years
|
|
Nervous system disorders
Seizure
|
18.8%
3/16 • 2 years
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • 2 years
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • 2 years
|
|
Psychiatric disorders
Depression
|
12.5%
2/16 • 2 years
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • 2 years
|
|
Psychiatric disorders
Personality change
|
6.2%
1/16 • 2 years
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
2/16 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16 • 2 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.2%
1/16 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.2%
1/16 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.2%
1/16 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.2%
1/16 • 2 years
|
|
Vascular disorders
Hypertension
|
31.2%
5/16 • 2 years
|
|
Vascular disorders
Phlebitis
|
6.2%
1/16 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place