Trial Outcomes & Findings for Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis (NCT NCT01705548)
NCT ID: NCT01705548
Last Updated: 2026-05-07
Results Overview
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
4 months
Results posted on
2026-05-07
Participant Flow
Participant milestones
| Measure |
Hypofractionated Radiosurgery - 6 Gy x 5 Level 0
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
9
|
|
Overall Study
COMPLETED
|
3
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
Baseline characteristics by cohort
| Measure |
Hypofractionated Radiosurgery- 6 Gy x 5 Level 0
n=3 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery- 6.5 Gy x 5 Level 1
n=12 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery-7 Gy x 5 Level 2
n=9 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 Years
n=54 Participants
|
67 Years
n=60 Participants
|
55 Years
n=114 Participants
|
67 Years
n=318 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
13 Participants
n=318 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
11 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=54 Participants
|
12 Participants
n=60 Participants
|
9 Participants
n=114 Participants
|
24 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=54 Participants
|
12 participants
n=60 Participants
|
9 participants
n=114 Participants
|
24 participants
n=318 Participants
|
PRIMARY outcome
Timeframe: 4 monthsGraded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI).
Outcome measures
| Measure |
Hypofractionated Radiosurgery
n=21 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Hypofractionated Radiosurgery Defined as the Highest Dose Level Where a Grade 3 or Greater With an Attribution Score of ≥ 3 Develops in ≤ 2 of 6 Patients in a Dose Group
|
6.5 Gy x 5 fractions
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsNumber
Outcome measures
| Measure |
Hypofractionated Radiosurgery
n=3 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
n=12 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
n=9 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Percentage of Participants With Neurologic Toxicity/Radiation Necrosis Possibly Due to Treatment, Graded According to the CTCAE Version 4.03 as Grade 2 or Greater.
|
0 percentage of participants
|
17 percentage of participants
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Pre-specified that data would be combined in the protocol. Pre-specified that data would be combined in the protocol because the study was designed to test safety (reported per dose level), but it was not hypothesized, designed or powered to support comparisons of efficacy outcomes between dose levels.
Cumulative incidences of local brain progression will be calculated by Kaplan-Meier method with 95% CI.
Outcome measures
| Measure |
Hypofractionated Radiosurgery
n=24 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Local Control; Lack of Progression of Disease in Resection Cavity as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria
|
6 Percentage of participants
Interval 4.0 to 25.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Pre-specified that data would be combined in the protocol. Pre-specified that data would be combined in the protocol because the study was designed to test safety (reported per dose level), but it was not hypothesized, designed or powered to support comparisons of efficacy outcomes between dose levels.
Percentage of patients with distant brain progression at the defined time point, with each individual patient's time to progression calculated by Kaplan-Meier method with 95% CI.
Outcome measures
| Measure |
Hypofractionated Radiosurgery
n=24 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Intercranial Progression Free Survival: Lack of Progression of Disease in Surrounding Brain as Defined by RECIST Criteria
|
46 Percentage of participants
Interval 30.0 to 71.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Pre-specified that data would be combined in the protocol. Pre-specified that data would be combined in the protocol because the study was designed to test safety (reported per dose level), but it was not hypothesized, designed or powered to support comparisons of efficacy outcomes between dose levels.
Outcome measures
| Measure |
Hypofractionated Radiosurgery
n=21 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Freedom From Failure/Progression Free Survival
|
7 Months
Interval 5.0 to 13.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Pre-specified that data would be combined in the protocol. Pre-specified that data would be combined in the protocol because the study was designed to test safety (reported per dose level), but it was not hypothesized, designed or powered to support comparisons of efficacy outcomes between dose levels.
The median of OS time with 95% CI will be calculated by Kaplan-Meier method.
Outcome measures
| Measure |
Hypofractionated Radiosurgery
n=20 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Overall Survival (OS): Death From Any Cause
|
9 months
Interval 6.0 to 22.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: Pre-specified that data would be combined in the protocol. Pre-specified that data would be combined in the protocol because the study was designed to test safety (reported per dose level), but it was not hypothesized, designed or powered to support comparisons of efficacy outcomes between dose levels.
Percentage of Participants with a Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Z-Score of ≤ -1.
Outcome measures
| Measure |
Hypofractionated Radiosurgery
n=15 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Scores
|
20 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Pre-specified that data would be combined in the protocol. Pre-specified that data would be combined in the protocol because the study was designed to test safety (reported per dose level), but it was not hypothesized, designed or powered to support comparisons of efficacy outcomes between dose levels.
Patients completed the FACT-BR at baseline and in follow-up. Responses are summed at each encounter to create a score. Total assessments combine scores range from 0-200. The higher the score, the better the QOL. Change from baseline to 4-month follow-up was calculated. A notable change is defined 20 point or greater increase or decrease in total score from baseline to 4-month follow-up score.
Outcome measures
| Measure |
Hypofractionated Radiosurgery
n=15 Participants
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Quality of Life (QOL) Outcomes: Using the Quality of Life Questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br).
Notably Improved Scores
|
4 participants
|
—
|
—
|
|
Quality of Life (QOL) Outcomes: Using the Quality of Life Questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br).
Overall Stable
|
11 participants
|
—
|
—
|
Adverse Events
Hypofractionated Radiosurgery - 6 Gy x 5 Level 0
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 6 deaths
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
Serious events: 3 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Hypofractionated Radiosurgery - 6 Gy x 5 Level 0
n=3 participants at risk
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
n=12 participants at risk
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
n=9 participants at risk
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/3 • 24 months
|
0.00%
0/12 • 24 months
|
11.1%
1/9 • Number of events 1 • 24 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • 24 months
|
0.00%
0/12 • 24 months
|
22.2%
2/9 • Number of events 2 • 24 months
|
Other adverse events
| Measure |
Hypofractionated Radiosurgery - 6 Gy x 5 Level 0
n=3 participants at risk
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery - 6.5 Gy x 5 Level 1
n=12 participants at risk
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
Hypofractionated Radiosurgery -7 Gy x 5 Level 2
n=9 participants at risk
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Hypofractionated Radiosurgery: Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 24 months
|
16.7%
2/12 • 24 months
|
0.00%
0/9 • 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • 24 months
|
16.7%
2/12 • 24 months
|
22.2%
2/9 • 24 months
|
|
Nervous system disorders
Aphasia
|
66.7%
2/3 • 24 months
|
0.00%
0/12 • 24 months
|
11.1%
1/9 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • 24 months
|
16.7%
2/12 • 24 months
|
0.00%
0/9 • 24 months
|
|
Nervous system disorders
Cognitive Disturbance
|
33.3%
1/3 • 24 months
|
8.3%
1/12 • 24 months
|
11.1%
1/9 • 24 months
|
|
Eye disorders
Visual Disturbance
|
33.3%
1/3 • 24 months
|
0.00%
0/12 • 24 months
|
11.1%
1/9 • 24 months
|
|
Nervous system disorders
Imbalance
|
0.00%
0/3 • 24 months
|
25.0%
3/12 • 24 months
|
33.3%
3/9 • 24 months
|
|
Psychiatric disorders
Mood Alteration
|
0.00%
0/3 • 24 months
|
8.3%
1/12 • 24 months
|
0.00%
0/9 • 24 months
|
|
General disorders
Fatigue
|
100.0%
3/3 • 24 months
|
66.7%
8/12 • 24 months
|
44.4%
4/9 • 24 months
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 24 months
|
50.0%
6/12 • 24 months
|
88.9%
8/9 • 24 months
|
|
Skin and subcutaneous tissue disorders
Radiation Necrosis
|
0.00%
0/3 • 24 months
|
50.0%
6/12 • 24 months
|
44.4%
4/9 • 24 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • 24 months
|
8.3%
1/12 • 24 months
|
33.3%
3/9 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 24 months
|
25.0%
3/12 • 24 months
|
11.1%
1/9 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Motor Weakness
|
0.00%
0/3 • 24 months
|
8.3%
1/12 • 24 months
|
44.4%
4/9 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 24 months
|
25.0%
3/12 • 24 months
|
11.1%
1/9 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place