Actively Recruiting
Stereotactic Radiosurgery Dose Escalation for Brain Metastases
Led by University of Utah · Updated on 2026-05-08
50
Participants Needed
1
Research Sites
673 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
H
Huntsman Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase I dose escalation and expansion trial. The purpose of this study is to determine the maximum tolerated dose of radiation received during stereotactic radiosurgery in patients with brain metastases who have never received radiation to the brain before.
CONDITIONS
Official Title
Stereotactic Radiosurgery Dose Escalation for Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically confirmed brain metastases by CT or MRI
- Prior brain surgery allowed if SRS is given 4-6 weeks post-surgery
- 1 to 5 untreated brain metastases total
- Tumor volume 64 4.1888 cm3 for Cohorts 1a and 1b
- Up to five metastases 64 0.5237 cm3 for Cohort 1a expansion
- Tumor volume 537 cm3 and 64 4.1888 cm3 for Cohort 1b
- Cohorts 2 and 3 closed; tumor diameter 64 40 mm for those enrolled
- Metastases must be at least 3 cm apart
- Appropriate washout from prior systemic therapy, especially BRAF inhibitors
- At least 18 years old
- Karnofsky Performance Status 60
- Able to provide informed consent
- Women of child-bearing potential must have negative pregnancy test and use birth control during and 3 months post radiation
- Men able to father children must use birth control during and 3 months post radiation
You will not qualify if you...
- Prior whole or partial brain irradiation
- Brain lesions larger than 40 mm in diameter
- Lesions in areas not suitable for SRS (e.g., optic nerve)
- Brain stem lesions
- Leptomeningeal disease
- Primary tumor types that are radiosensitive (small cell carcinoma, germ cell tumors, lymphoma, leukemia, multiple myeloma)
- Pregnant or breastfeeding women of child-bearing potential
- Patients with multiple lesions assigned to a full cohort where dose-limiting toxicity period is ongoing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
D
David Ostler
CONTACT
C
Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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