Trial Outcomes & Findings for Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study (NCT NCT04047602)

Last Updated: 2025-02-13

Results Overview

The observed proportion of evaluable patients with symptomatic radiation necrosis by 6-months. Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis.

Recruitment status

TERMINATED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

6 months

Results posted on

2025-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reduced Dose Stereotactic Radiosurgery n=12 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Age, Continuous	63.08 years STANDARD_DEVIATION 7.59 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
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	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Corticosteroid Use at Baseline No	10 Participants n=5 Participants
Corticosteroid Use at Baseline Yes	2 Participants n=5 Participants
Diagnosis-Specific Graded Prognostic Assessment (ds-GPA) Median Survival at Baseline	11.75 years n=5 Participants
Primary Site of Initial Cancer Diagnosis Adrenal Gland	1 Participants n=5 Participants
Primary Site of Initial Cancer Diagnosis Brain	1 Participants n=5 Participants
Primary Site of Initial Cancer Diagnosis Kidney/Renal Pelvis	2 Participants n=5 Participants
Primary Site of Initial Cancer Diagnosis Lung	6 Participants n=5 Participants
Primary Site of Initial Cancer Diagnosis Melanoma	2 Participants n=5 Participants
Number of Lesions at Baseline	1.50 lesions n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Includes those patients who were evaluable for the 6-month outcomes.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=12 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Symptomatic Radiation Necrosis Proportion	0.083 proportion of participants Interval 0.002 to 0.385	—

SECONDARY outcome

Timeframe: 6 months

Population: Includes the patients who were evaluable for the 6-month outcomes.

Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=12 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Symptomatic Radiation Necrosis Rate	0.913 survival probability Interval 0.524 to 0.987	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes the patients who were evaluable for the 12-month outcomes.

Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=12 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Symptomatic Radiation Necrosis Rate	0.913 survival probability Interval 0.524 to 0.987	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes the patients who were evaluable for the 12-month outcomes.

Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=8 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator n=4 Participants Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Symptomatic Radiation Necrosis by SRS Group	0.875 survival probability Interval 0.387 to 0.981	1.000 survival probability Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: 12 months

Population: Includes the patients who were evaluable for the 12-month outcomes.

Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=2 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator n=10 Participants Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Symptomatic Radiation Necrosis by Brain Metastases Group	1.000 survival probability Interval 1.0 to 1.0	0.900 survival probability Interval 0.473 to 0.985

SECONDARY outcome

Timeframe: 12 months

Population: Includes the patients who were evaluable for the 12-month outcomes.

Symptomatic radiation necrosis was defined as the rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of symptomatic radiation necrosis was calculated. Ppatients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=9 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator n=3 Participants Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Symptomatic Radiation Necrosis by Immune Checkpoint Inhibitor (ICI) Group	0.889 survival probability Interval 0.433 to 0.984	1.000 survival probability Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: 6 months

Population: Includes patients evaluable for 6-month outcomes.

Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=12 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Local Control	1.00 survival probability Interval 1.0 to 1.0	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes patients evaluable for 12-month outcomes.

Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=12 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Local Control	0.913 survival probability Interval 0.524 to 0.987	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes patients who were evaluable for the 12-month outcomes.

Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=8 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator n=4 Participants Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Local Control by SRS Group	1.00 survival probability Interval 1.0 to 1.0	0.750 survival probability Interval 0.128 to 0.961

SECONDARY outcome

Timeframe: 12 months

Population: Includes patients who were evaluable for the 12-month outcomes.

Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=2 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator n=10 Participants Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Local Control by Brain Metastases Group	1.00 survival probability Interval 1.0 to 1.0	0.900 survival probability Interval 0.473 to 0.985

SECONDARY outcome

Timeframe: 12 months

Population: Includes patients who were evaluable for the 12-month outcomes.

Local control was defined as the rate of any new, recurrent, or progressing tumor as defined by Response Assessment in Neuro-oncology (RANO) criteria within the planning target volume. This measure details the estimated 12-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to local failure was calculated. Patients who did not experience local failure were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=9 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator n=3 Participants Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Local Control by Immune Checkpoint Inhibitor (ICI) Group	0.889 survival probability Interval 0.433 to 0.984	1.00 survival probability Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: 6 months

Population: Includes the patients who were evaluable for the 6-month outcomes.

Radiographic radiation necrosis was defined as brain imaging findings on magnetic resonance imaging (MRI), magnetic resonance (MR) perfusion, MR Spectroscopy, and/or positron emission tomography (PET) imaging consistent with radiation necrosis. This measure details the estimated 6-month survival and associated 95% confidence interval from the Kaplan Meier method. The time from treatment start to the presence of radiographic radiation necrosis was calculated. Patients who did not experience the outcome were censored at the date last known alive or at the date of death if they expired.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=12 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Radiographic Radiation Necrosis Rate	0.818 survival probability Interval 0.447 to 0.951	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes the patients who were evaluable for the 12-month outcomes.

Outcome measures

Outcome measures
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=12 Participants Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size	Linear Accelerator Subjects received Linear Accelerator SRS. Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Radiographic Radiation Necrosis Rate	0.818 survival probability Interval 0.447 to 0.951	—

Adverse Events

Reduced Dose Stereotactic Radiosurgery With Immunotherapy

Serious events: 1 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=18 participants at risk Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.6% 1/18 • Number of events 1 • Up to 28 Months Adverse events reported are those that are related to the SRS treatment and are as of February 2024. Patients are still on follow-up for the study and treatment-related adverse events can still occur. Patients were considered at risk for an adverse event if they started SRS treatment. For all-cause mortality and serious adverse events, treatment attribution was not considered.

Other adverse events

Other adverse events
Measure	Reduced Dose Stereotactic Radiosurgery With Immunotherapy n=18 participants at risk Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
General disorders Fatigue	11.1% 2/18 • Up to 28 Months Adverse events reported are those that are related to the SRS treatment and are as of February 2024. Patients are still on follow-up for the study and treatment-related adverse events can still occur. Patients were considered at risk for an adverse event if they started SRS treatment. For all-cause mortality and serious adverse events, treatment attribution was not considered.
Nervous system disorders Headache	22.2% 4/18 • Up to 28 Months Adverse events reported are those that are related to the SRS treatment and are as of February 2024. Patients are still on follow-up for the study and treatment-related adverse events can still occur. Patients were considered at risk for an adverse event if they started SRS treatment. For all-cause mortality and serious adverse events, treatment attribution was not considered.
Skin and subcutaneous tissue disorders Alopecia	5.6% 1/18 • Up to 28 Months Adverse events reported are those that are related to the SRS treatment and are as of February 2024. Patients are still on follow-up for the study and treatment-related adverse events can still occur. Patients were considered at risk for an adverse event if they started SRS treatment. For all-cause mortality and serious adverse events, treatment attribution was not considered.
Metabolism and nutrition disorders Anorexia	5.6% 1/18 • Up to 28 Months Adverse events reported are those that are related to the SRS treatment and are as of February 2024. Patients are still on follow-up for the study and treatment-related adverse events can still occur. Patients were considered at risk for an adverse event if they started SRS treatment. For all-cause mortality and serious adverse events, treatment attribution was not considered.
Nervous system disorders Dizziness	5.6% 1/18 • Up to 28 Months Adverse events reported are those that are related to the SRS treatment and are as of February 2024. Patients are still on follow-up for the study and treatment-related adverse events can still occur. Patients were considered at risk for an adverse event if they started SRS treatment. For all-cause mortality and serious adverse events, treatment attribution was not considered.

Additional Information

Kevin Shiue, MD

Indiana University Health

Phone: 317 944 2524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place