Trial Outcomes & Findings for SIMT Stereotactic Radiosurgery Outcomes Study (NCT NCT02886572)

Last Updated: 2022-06-01

Results Overview

Calculated from the time of protocol Stereotactic RadioSurgery (SRS). The GPA incorporates four factors: age, KPS (Karnofsky Performance Score), ECM (extracranial metastases) and number of BM (brain metastases). Each factor is given a score of 0, 0.5 or 1.0 and GPA is calculated as a sum score of all four factors. The GPA has four groups: the GPA 0-1 with median survival of 2.6 months; GPA 1.5-2.5 with survival of 3.8 months; GPA 3 with median survival of 6.9 months and GPA 3.5-4.0 with the best median survival of 11 months.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Up to 24 months after SRS

Results posted on

2022-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Radiosurgery All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014 Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Overall Study STARTED	40
Overall Study Survival Analysis Population	40
Overall Study Distant Brain Recurrence	32
Overall Study Local Recurrence	32
Overall Study Time to Neurologic Death	32
Overall Study SRS Related Adverse Events	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Stereotactic Radiosurgery All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014 Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Overall Study Death	8

Baseline Characteristics

SIMT Stereotactic Radiosurgery Outcomes Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Radiosurgery n=40 Participants All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014 Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 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	7 Participants n=5 Participants
Race (NIH/OMB) White	33 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
Karnofsky performance status	90 units on a scale (percentage) n=5 Participants
Number of Metastases per participant	6 metastases n=5 Participants
Prior brain surgery for metastasis	36 Participants n=5 Participants
Prior stereotactic radiosurgery or whole brain radiation	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months after SRS

Population: Participants who completed the study.

Outcome measures

Outcome measures
Measure	Stereotactic Radiosurgery n=32 Participants All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014 Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Number of Participants Who Live Longer Than Predicted According to the Graded Prognostic Assessment (GPA) Score	22 Participants

SECONDARY outcome

Timeframe: Up to 12 months after SRS

Population: Participants who completed the study.

Local recurrence of brain metastases is based on serial MRIs every 3 months and estimated by Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Stereotactic Radiosurgery n=32 Participants All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014 Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Number of Participants Who Experience Local Brain Recurrence Within 1 Year of SIMT SRS Treatment	4 Participants

SECONDARY outcome

Timeframe: Up to 12 months after SRS

Time to neurologic death is defined as the time between initiation of SIMT SRS and death due to neurologic causes and is estimated using Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Stereotactic Radiosurgery n=40 Participants All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014 Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Number of Participants Who Are Dead Within 1 Year of SIMT SRS Treatment Due to Neurologic Reasons	30 Participants

SECONDARY outcome

Timeframe: Up to 12 months after SRS

Distant recurrence of brain metastases is based on serial MRIs every 3 months and estimated by Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Stereotactic Radiosurgery n=40 Participants All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014 Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Number of Participants Who Experience a New Brain Metastasis at a Site Different From the Original Brain Metastasis Site 1 Year After SIMT SRS Treatment	19 Participants

SECONDARY outcome

Timeframe: Up to 12 months after SRS

Population: Participants who completed the study.

Adverse Events only included those that were deemed by the PI to be related to the SIMT SRS treatment.

Outcome measures

Outcome measures
Measure	Stereotactic Radiosurgery n=32 Participants All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014 Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Number of Participants Who Experience Grade 3, 4, or 5 Neurologic Adverse Events Attributable to SIMT SRS	0 Participants

Adverse Events

Stereotactic Radiosurgery

Serious events: 0 serious events

Other events: 16 other events

Deaths: 39 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Stereotactic Radiosurgery n=40 participants at risk All subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014 Stereotactic radiosurgery: Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
Gastrointestinal disorders Nausa	25.0% 10/40 • Number of events 10 • 2 years Serious Adverse Events were only collected if they were grade 3, 4, or 5 event and were deemed by the Principal Investigator to be probably, possibly, or definitely related to the SRS treatment.
Eye disorders Eye disorders: other, specify (decrease visual acuity)	5.0% 2/40 • Number of events 2 • 2 years Serious Adverse Events were only collected if they were grade 3, 4, or 5 event and were deemed by the Principal Investigator to be probably, possibly, or definitely related to the SRS treatment.
Gastrointestinal disorders Vomiting	5.0% 2/40 • Number of events 2 • 2 years Serious Adverse Events were only collected if they were grade 3, 4, or 5 event and were deemed by the Principal Investigator to be probably, possibly, or definitely related to the SRS treatment.
Nervous system disorders Headache	40.0% 16/40 • Number of events 16 • 2 years Serious Adverse Events were only collected if they were grade 3, 4, or 5 event and were deemed by the Principal Investigator to be probably, possibly, or definitely related to the SRS treatment.
General disorders Gait disturbance	7.5% 3/40 • Number of events 3 • 2 years Serious Adverse Events were only collected if they were grade 3, 4, or 5 event and were deemed by the Principal Investigator to be probably, possibly, or definitely related to the SRS treatment.
Nervous system disorders Dizziness	5.0% 2/40 • Number of events 2 • 2 years Serious Adverse Events were only collected if they were grade 3, 4, or 5 event and were deemed by the Principal Investigator to be probably, possibly, or definitely related to the SRS treatment.
Nervous system disorders Memory impairment	7.5% 3/40 • Number of events 3 • 2 years Serious Adverse Events were only collected if they were grade 3, 4, or 5 event and were deemed by the Principal Investigator to be probably, possibly, or definitely related to the SRS treatment.
Skin and subcutaneous tissue disorders Alopecia	20.0% 8/40 • Number of events 8 • 2 years Serious Adverse Events were only collected if they were grade 3, 4, or 5 event and were deemed by the Principal Investigator to be probably, possibly, or definitely related to the SRS treatment.
Skin and subcutaneous tissue disorders Scalp pain	7.5% 3/40 • Number of events 3 • 2 years Serious Adverse Events were only collected if they were grade 3, 4, or 5 event and were deemed by the Principal Investigator to be probably, possibly, or definitely related to the SRS treatment.

Additional Information

Joan Cahill BNS OCN CCRP

Duke University Health System

Phone: (919) 668-5211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place