Clinical trial · Interventional
SIMT Stereotactic Radiosurgery Outcomes Study
Outcome in Patients With 4 or More Brain Metastases Treated With Single-Isocenter, Multi-Target (SIMT) Stereotactic Radiosurgery: A Prospective Single-arm Study in Adults With Brain Metastases
NCT02886572CI-TRIAL-00058814SIMTcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases, Adult | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiosurgery
- description
- 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
- interventionNames
- Radiation: Stereotactic radiosurgery
Primary outcomes (1)
- measure
- Number of Participants Who Live Longer Than Predicted According to the Graded Prognostic Assessment (GPA) Score
- timeFrame
- Up to 24 months after SRS
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. A contrast-enhanced MRI scan showing = or \> 4 brain metastases. 2. Age \>/=18 years of age. 3. KPS \>/= 70 4. Patient must have a graded prosnostic score (GPA) score 0.5 or greater 5. Life expectancy of at least 3 months 6. Postoperative patients with resected brain metastases are eligible. 7. Largest lesion \< 4cm diameter 8. Must be a candidate for MRI imaging 9. Previous cranial stereotactic radiosurgery (SRS) or whole brain radiation therapy (WBRT) is allowed if \> 3 months prior to SIMT 10. Must be capable of providing informed consent Exclusion Criteria: 1. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma). 2. Metastases within 2 mm of the optic apparatus 3. Patients unable to obtain MRI 4. Evidence of leptomeningeal disease 5. Greater than 10 brain metastases 6. Pregnant women are excluded
References
Publications (1)
- RESULTKim GJ, Buckley ED, Herndon JE, Allen KJ, Dale TS, Adamson JD, Lay L, Giles WM, Rodrigues AE, Wang Z, Kelsey CR, Torok JA Jr, Chino JP, Fecci PE, Sampson JH, Anders CK, Floyd SR, Yin FF, Kirkpatrick JP. Outcomes in Patients With 4 to 10 Brain Metastases Treated With Dose-Adapted Single-Isocenter Multitarget Stereotactic Radiosurgery: A Prospective Study. Adv Radiat Oncol. 2021 Jul 23;6(6):100760. doi: 10.1016/j.adro.2021.100760. eCollection 2021 Nov-Dec. PMID 34934856