NCT02886572: SIMT

SIMT Stereotactic Radiosurgery Outcomes Study

Completed NA Results posted Last updated 1 June 2022

What this trial tests

NA trial testing Stereotactic radiosurgery in Brain Metastases, Adult in 40 participants. Completed in 30 April 2021.

Timeline

25 January 2017

Primary endpoint
30 April 2021

30 April 2021

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	25 January 2017
Primary completion	30 April 2021
Estimated completion	30 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Stereotactic radiosurgery

Conditions studied

• Brain Metastases, Adult — all drugs for Brain Metastases, Adult →

Sponsor

Duke University

Who can join

18 and older, any sex, with Brain Metastases, Adult. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Live Longer Than Predicted According to the Graded Prognostic Assessment (GPA) Score Primary · Up to 24 months after SRS

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.

Group	Value	95% CI
Stereotactic Radiosurgery	22

Number of Participants Who Experience Local Brain Recurrence Within 1 Year of SIMT SRS Treatment Secondary · Up to 12 months after SRS

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

Group	Value	95% CI
Stereotactic Radiosurgery	4

Number of Participants Who Are Dead Within 1 Year of SIMT SRS Treatment Due to Neurologic Reasons Secondary · 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.

Group	Value	95% CI
Stereotactic Radiosurgery	30

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 Secondary · 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.

Group	Value	95% CI
Stereotactic Radiosurgery	19

Number of Participants Who Experience Grade 3, 4, or 5 Neurologic Adverse Events Attributable to SIMT SRS Secondary · Up to 12 months after SRS

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

Group	Value	95% CI
Stereotactic Radiosurgery	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stereotactic Radiosurgery

Serious: 0/40 (0%)

Deaths: 39/40

Other adverse events (9 terms — click to expand)

Reaction	System	Stereotactic Radiosurgery
Headache	Nervous system disorders	—
Nausa	Gastrointestinal disorders	—
Alopecia	Skin and subcutaneous tissue disorders	—
Gait disturbance	General disorders	—
Memory impairment	Nervous system disorders	—
Scalp pain	Skin and subcutaneous tissue disorders	—
Eye disorders: other, specify (decrease visual acuity)	Eye disorders	—
Vomiting	Gastrointestinal disorders	—
Dizziness	Nervous system disorders	—

Data from ClinicalTrials.gov NCT02886572 adverse events section.

Sponsor's own description

The purpose of this study is to determine the effectiveness and efficiency of Single Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more brain metastases

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Single fraction stereotactic radiosurgery for multiple brain metastases.
   Limon D, McSherry F, Herndon J, Sampson J, et al · · 2017 · cited 48× · PMID 29204522 · DOI 10.1016/j.adro.2017.09.002
2. Executive summary from American Radium Society's appropriate use criteria on neurocognition after stereotactic radiosurgery for multiple brain metastases.
   Milano MT, Chiang VLS, Soltys SG, Wang TJC, et al · · 2020 · cited 27× · PMID 32780818 · DOI 10.1093/neuonc/noaa192
3. Outcomes in Patients With 4 to 10 Brain Metastases Treated With Dose-Adapted Single-Isocenter Multitarget Stereotactic Radiosurgery: A Prospective Study.
   Kim GJ, Buckley ED, Herndon JE, Allen KJ, et al · · 2021 · cited 18× · PMID 34934856 · DOI 10.1016/j.adro.2021.100760
4. Preservation of neurocognitive function in the treatment of brain metastases.
   Parsons MW, Peters KB, Floyd SR, Brown P, et al · · 2021 · cited 16× · PMID 34859237 · DOI 10.1093/noajnl/vdab122