Radiosurgery Before Surgery for the Treatment of Brain Metastases
Completed · Early Phase 1
Conditions studied: Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
In brief
This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimulate an anti-tumor immune response. Giving stereotactic radiosurgery before surgery may reduce the risk of the cancer coming back after surgery.
Key facts
- Study ID
- NCT04895592
- Run by
- Emory University
- People needed
- 26
- Starts
- 2021-07-20
- Expected to finish
- 2026-03-04
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >= 18 years
- Prior or suspected diagnosis of malignancy
- Brain metastases visible on contrasted magnetic resonance imaging (MRI) brain
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Life expectancy > 12 weeks as determined by the investigator
- Patients must have adequate organ function as determined by Neurosurgery to undergo surgery
- Willingness and ability of the subject to comply with scheduled visits, study procedures, and study restrictions
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
- Patient must have a negative pregnancy test, be actively taking oral contraceptives or have undergone a hysterectomy
You may not qualify if…
- Patients on any immunosuppressive medication other than dexamethasone
- Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV)-positive
- Pregnant or nursing women are excluded
- Prior whole brain radiotherapy or SRS to the same site planned for surgery
Where it is running
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.