N/A
Completed N=40
SIMT Stereotactic Radiosurgery Outcomes Study
Brain Metastases, Adult
Source: ClinicalTrials.gov NCT02886572 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: Number of Participants Who Live Longer Than Predicted According to the Graded Prognostic Assessment (GPA) Score — 22 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Live Longer Than Predicted According to the Graded Prognostic Assessment (GPA) Score |
22 | — |
| SECONDARY Number of Participants Who Experience Local Brain Recurrence Within 1 Year of SIMT SRS Treatment |
4 | — |
| SECONDARY Number of Participants Who Are Dead Within 1 Year of SIMT SRS Treatment Due to Neurologic Reasons |
30 | — |
| SECONDARY 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 | — |
| SECONDARY Number of Participants Who Experience Grade 3, 4, or 5 Neurologic Adverse Events Attributable to SIMT SRS |
— | — |
Eligibility Criteria
Inclusion Criteria
- A contrast-enhanced MRI scan showing = or > 4 brain metastases.
- Age >/=18 years of age.
- KPS >/= 70
- Patient must have a graded prosnostic score (GPA) score 0.5 or greater
- Life expectancy of at least 3 months
- Postoperative patients with resected brain metastases are eligible.
- Largest lesion 3 months prior to SIMT
- Must be capable of providing informed consent
Exclusion Criteria
- Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
- Metastases within 2 mm of the optic apparatus
- Patients unable to obtain MRI
- Evidence of leptomeningeal disease
- Greater than 10 brain metastases
- Pregnant women are excluded
Data sourced from ClinicalTrials.gov (NCT02886572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.