Trial Outcomes & Findings for Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases (NCT NCT00928226)
NCT ID: NCT00928226
Last Updated: 2024-01-30
Results Overview
The maximum-tolerated Dose (MTD) of stereotactic radiosurgery (SRS) was assessed based on the number of dose-limiting toxicities (DLTs). DLT was defined as any treatment-related grade 3, 4, or 5 central nervous system (CNS) radiation morbidity observed within 30 days of radiosurgery. CNS radiation morbidity was further defined as. * 5 = Death * 4 = Serious neurologic impairment such as paralysis, coma, or seizures \> 3/week * 3 = Neurologic findings requiring hospitalization * 2 = Neurologic findings present sufficient to require attendant care * 1 = Fully functional status (ie, able to work) with minor neurologic findings; no medication needed * 0 = No Change The outcome is expressed as number of DLTs experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. Per protocol, the MTD of SRS was defined as either the dose level below that at which 4+ DLTs were experienced by 12 subjects, or the maximum dose administered without MTD.
COMPLETED
NA
56 participants
60 days
2024-01-30
Participant Flow
Participant milestones
| Measure |
Arm 1 - 24 Grey SRS
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
12
|
12
|
12
|
|
Overall Study
Strata A: Small Tumor, Resected
|
6
|
6
|
6
|
6
|
|
Overall Study
Strata B: Small Tumor, Not Resected
|
5
|
0
|
0
|
0
|
|
Overall Study
Strata C: Large Tumor, Resected
|
8
|
6
|
6
|
6
|
|
Overall Study
Strata D: Large Tumor, Not Resected
|
1
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
20
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Fractionated Stereotactic Radiosurgery to Treat Large Brain Metastases
Baseline characteristics by cohort
| Measure |
Arm 1 - 24 Grey SRS
n=20 Participants
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=12 Participants
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=12 Participants
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 Participants
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
56 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS).
The maximum-tolerated Dose (MTD) of stereotactic radiosurgery (SRS) was assessed based on the number of dose-limiting toxicities (DLTs). DLT was defined as any treatment-related grade 3, 4, or 5 central nervous system (CNS) radiation morbidity observed within 30 days of radiosurgery. CNS radiation morbidity was further defined as. * 5 = Death * 4 = Serious neurologic impairment such as paralysis, coma, or seizures \> 3/week * 3 = Neurologic findings requiring hospitalization * 2 = Neurologic findings present sufficient to require attendant care * 1 = Fully functional status (ie, able to work) with minor neurologic findings; no medication needed * 0 = No Change The outcome is expressed as number of DLTs experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion. Per protocol, the MTD of SRS was defined as either the dose level below that at which 4+ DLTs were experienced by 12 subjects, or the maximum dose administered without MTD.
Outcome measures
| Measure |
Arm 1 - 24 Grey SRS
n=20 Participants
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=12 Participants
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=12 Participants
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 Participants
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD)
Strata A: Small tumor, resected
|
0 Dose-limited toxicity (DLT) events
|
0 Dose-limited toxicity (DLT) events
|
0 Dose-limited toxicity (DLT) events
|
0 Dose-limited toxicity (DLT) events
|
|
Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD)
Strata B: Small tumor, not resected
|
0 Dose-limited toxicity (DLT) events
|
—
|
—
|
—
|
|
Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD)
Strata C: Large tumor, resected
|
0 Dose-limited toxicity (DLT) events
|
0 Dose-limited toxicity (DLT) events
|
0 Dose-limited toxicity (DLT) events
|
0 Dose-limited toxicity (DLT) events
|
|
Stereotactic Radiosurgery (SRS) Maximum-tolerated Dose (MTD)
Strata D: Large tumor, not resected
|
0 Dose-limited toxicity (DLT) events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants with 12-month treatment response data are included.
Local disease control (treatment response) was assessed on the basis of tumor size before and 12 months after treatment. Treatment response was based on the following criteria. Tumor area is determined as the product of 2 measurements of lesion diameter. * Complete response (CR): The tumor is no longer seen within the radiosurgical target volume * Partial response (PR): Decrease of \> 50% in tumor area * Minor response (MR): Decrease of \< 50% in tumor area * Stable disease (SD): The scan shows no change. * Progression (P): A \> 25% increase in tumor area, or any new lesion within the radiosurgical target volume. Local control is defined as as any treatment response other than progression. The outcome is as the number of participants that did not progress, by radiotherapy dose cohort and tumor size, a number without dispersion.
Outcome measures
| Measure |
Arm 1 - 24 Grey SRS
n=11 Participants
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=10 Participants
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=12 Participants
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 Participants
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Local Disease Control
Strata C: Large tumor, resected
|
5 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Local Disease Control
Strata A: Small tumor, resected
|
4 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Local Disease Control
Strata B: Small tumor, not resected
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants with 12-month disease status data are included.
Distant treatment failure (failure to achieve or maintain disease control) is defined as the radiographic appearance of a new or enhancing lesion more than 5 mm from the radiosurgical target volume. The outcome is expressed as the number of participants who have distant treatment failure after radiotherapy dose cohort and tumor size, a number without dispersion.
Outcome measures
| Measure |
Arm 1 - 24 Grey SRS
n=11 Participants
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=10 Participants
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=9 Participants
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 Participants
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Distant Intra-cranial Disease Control
Strata A: Small tumor, resected
|
4 participants
|
3 participants
|
2 participants
|
2 participants
|
|
Distant Intra-cranial Disease Control
Strata B: Small tumor, not resected
|
2 participants
|
—
|
—
|
—
|
|
Distant Intra-cranial Disease Control
Strata C: Large tumor, resected
|
3 participants
|
3 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS).
Short-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring within 30 days of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion.
Outcome measures
| Measure |
Arm 1 - 24 Grey SRS
n=20 Participants
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=12 Participants
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=12 Participants
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 Participants
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Adverse Effects Within 30 Days
Strata A: Small tumor, resected
|
3 adverse events
|
4 adverse events
|
4 adverse events
|
2 adverse events
|
|
Adverse Effects Within 30 Days
Strata B: Small tumor, not resected
|
3 adverse events
|
—
|
—
|
—
|
|
Adverse Effects Within 30 Days
Strata C: Large tumor, resected
|
4 adverse events
|
2 adverse events
|
2 adverse events
|
3 adverse events
|
|
Adverse Effects Within 30 Days
Strata D: Large tumor, not resected
|
1 adverse events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: after 30 days and up to 1 yearPopulation: There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants surviving more than 30 days are included.
Long-term adverse effects are defined as any adverse event related to the stereotactic radiosurgery (SRS), and occurring more 30 days but within 12 months of SRS. The outcome is expressed as the number of events experienced by participants, by radiotherapy dose cohort and tumor size, a number without dispersion.
Outcome measures
| Measure |
Arm 1 - 24 Grey SRS
n=19 Participants
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=12 Participants
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=12 Participants
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 Participants
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Adverse Effects More Than 30 Days up to 1 Year
Strata A: Small tumor, resected
|
6 adverse events
|
1 adverse events
|
3 adverse events
|
2 adverse events
|
|
Adverse Effects More Than 30 Days up to 1 Year
Strata B: Small tumor, not resected
|
1 adverse events
|
—
|
—
|
—
|
|
Adverse Effects More Than 30 Days up to 1 Year
Strata C: Large tumor, resected
|
3 adverse events
|
4 adverse events
|
6 adverse events
|
5 adverse events
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS).
Overall survival (OS) is assessed as remaining alive 3 years after stereotactic radiosurgery (SRS) therapy. The outcome is expressed as the number of participants alive 3 years after SRS, by radiotherapy dose cohort and tumor size, a number without dispersion.
Outcome measures
| Measure |
Arm 1 - 24 Grey SRS
n=20 Participants
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=12 Participants
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=12 Participants
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 Participants
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Overall Survival (OS)
Strata A: Small tumor, resected
|
3 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Overall Survival (OS)
Strata B: Small tumor, not resected
|
2 Participants
|
—
|
—
|
—
|
|
Overall Survival (OS)
Strata C: Large tumor, resected
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Overall Survival (OS)
Strata D: Large tumor, not resected
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants providing 6-month European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) health-related quality of life (HR-QoL) data are included.
Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) survey, a survey of 28 questions with the following responses / numerical values. 1. Not at all 2. A Little 3. Quite a Bit 4. Very Much Response range is 28 to 112, normalized to a 100 point scale. Lower values indicate little effect of disease, and higher values indicate greater effect. The outcome is expressed as the median value with full range, by radiotherapy dose cohort and tumor size.
Outcome measures
| Measure |
Arm 1 - 24 Grey SRS
n=15 Participants
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=11 Participants
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=6 Participants
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 Participants
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30
Strata A: Small tumor, resected
|
100 score on a scale
Interval 58.3 to 100.0
|
83.3 score on a scale
Interval 16.7 to 100.0
|
75 score on a scale
Interval 16.7 to 100.0
|
50 score on a scale
Interval 33.3 to 100.0
|
|
Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30
Strata B: Small tumor, not resected
|
75 score on a scale
Interval 66.7 to 87.3
|
—
|
—
|
—
|
|
Health-related Quality of Life (HR-QoL), as Measured by EORTC QLQ-C30
Strata C: Large tumor, resected
|
87.5 score on a scale
Interval 83.3 to 96.7
|
75 score on a scale
Interval 25.0 to 100.0
|
83.3 score on a scale
Interval 83.3 to 83.3
|
83.3 score on a scale
Interval 58.33 to 83.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were few participants who did not receive tumor resection, and these were restricted to Arm 1 (24 Grey SRS). Only participants with 6-month European Organisation for Research and Treatment of Cancer (EORTC) Brain Cancer Module (QLQ-BN20) health-related quality of life (HR-QoL) data are included.
Health-related quality of life (HR-QoL), was assessed based on the European Organisation for Research and Treatment of Cancer (EORTC) Brain Cancer Module (QLQ-BN20), a survey of 20 questions with the following responses / numerical values. 1. Not at all 2. A Little 3. Quite a Bit 4. Very Much Response range is 20 to 80, normalized to a 0 to 100 scale. Lower values indicate little effect of disease, and higher values indicate greater effect. The outcome is expressed as the median value with full range, by radiotherapy dose cohort and tumor size.
Outcome measures
| Measure |
Arm 1 - 24 Grey SRS
n=16 Participants
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=11 Participants
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=6 Participants
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 Participants
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20
Strata C: Large tumor, resected
|
12.5 score on a scale
Interval 8.3 to 33.3
|
33.3 score on a scale
Interval 0.0 to 83.3
|
8.3 score on a scale
Interval 0.0 to 16.7
|
8.3 score on a scale
Interval 0.0 to 16.7
|
|
Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20
Strata A: Small tumor, resected
|
0 score on a scale
Interval 0.0 to 8.3
|
16.7 score on a scale
Interval 0.0 to 75.0
|
16.5 score on a scale
Interval 0.0 to 33.3
|
16.7 score on a scale
Interval 0.0 to 25.0
|
|
Health-related Quality of Life (HR-QoL), as Measured by EORTC Brain Cancer Module QLQ-BN20
Strata B: Small tumor, not resected
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
—
|
Adverse Events
Arm 1 - 24 Grey SRS
Arm 2 - 27 Grey SRS
Arm 3 - 30 Grey SRS
Arm 4 - 33 Grey SRS
Serious adverse events
| Measure |
Arm 1 - 24 Grey SRS
n=20 participants at risk
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=12 participants at risk
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=12 participants at risk
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 participants at risk
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Nervous system disorders
Nervous system disorders
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Nervous system disorders
Seizure
|
5.0%
1/20 • Number of events 2 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/20 • 3 years
|
8.3%
1/12 • Number of events 2 • 3 years
|
0.00%
0/12 • 3 years
|
0.00%
0/12 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders -Others, Renal Failure
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Others, retrosigmoid stent migration to colon wall
|
0.00%
0/20 • 3 years
|
8.3%
1/12 • Number of events 2 • 3 years
|
0.00%
0/12 • 3 years
|
0.00%
0/12 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Nervous system disorders
Altered mental status
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
General disorders
Pain-leg pain
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
General disorders
Multi-organ failure
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
0.00%
0/12 • 3 years
|
0.00%
0/12 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified-Other disease progression
|
45.0%
9/20 • Number of events 9 • 3 years
|
25.0%
3/12 • Number of events 3 • 3 years
|
0.00%
0/12 • 3 years
|
0.00%
0/12 • 3 years
|
|
General disorders
Death NOS
|
10.0%
2/20 • Number of events 2 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Infections and infestations
Infection and infectations-other, fever
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
16.7%
2/12 • Number of events 3 • 3 years
|
0.00%
0/12 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
Other adverse events
| Measure |
Arm 1 - 24 Grey SRS
n=20 participants at risk
24 Grey administered as 8 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 2 - 27 Grey SRS
n=12 participants at risk
27 Grey administered as 9 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 3 - 30 Grey SRS
n=12 participants at risk
30 Grey administered as 10 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
Arm 4 - 33 Grey SRS
n=12 participants at risk
33 Grey administered as 11 Gy x 3 fractions
Fractionated Stereotactic Radiosurgery (SRS): Standard of care
Surgical resection: Standard of care
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Allopecia
|
5.0%
1/20 • Number of events 1 • 3 years
|
41.7%
5/12 • Number of events 5 • 3 years
|
58.3%
7/12 • Number of events 7 • 3 years
|
33.3%
4/12 • Number of events 4 • 3 years
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 4 • 3 years
|
25.0%
3/12 • Number of events 3 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
33.3%
4/12 • Number of events 4 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
4/20 • Number of events 4 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
General disorders
Fatigue
|
10.0%
2/20 • Number of events 2 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
25.0%
3/12 • Number of events 3 • 3 years
|
33.3%
4/12 • Number of events 4 • 3 years
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • Number of events 1 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
0.00%
0/12 • 3 years
|
0.00%
0/12 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/20 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
0.00%
0/12 • 3 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/20 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders-Other, imbalance
|
5.0%
1/20 • Number of events 1 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Nervous system disorders
Central nervous system necrosis
|
10.0%
2/20 • Number of events 2 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
41.7%
5/12 • Number of events 5 • 3 years
|
|
Eye disorders
Eye disorders - Other, diplopia
|
0.00%
0/20 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
0.00%
0/12 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • 3 years
|
25.0%
3/12 • Number of events 3 • 3 years
|
16.7%
2/12 • Number of events 2 • 3 years
|
0.00%
0/12 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/20 • 3 years
|
0.00%
0/12 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
|
Eye disorders
Eye disorders - Other, visual field loss
|
10.0%
2/20 • Number of events 2 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
25.0%
3/12 • Number of events 3 • 3 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/20 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
0.00%
0/12 • 3 years
|
|
Gastrointestinal disorders
Vomitting
|
5.0%
1/20 • Number of events 1 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
8.3%
1/12 • Number of events 1 • 3 years
|
0.00%
0/12 • 3 years
|
Additional Information
Scott Soltys, Associate Professor of Radiation Oncology
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place