Actively Recruiting
A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases
Led by Stony Brook University · Updated on 2025-05-14
26
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stony Brook University
Lead Sponsor
T
The University of Texas Health Science Center at San Antonio
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy (SBRT) alone, potentially avoiding major spine surgery. This phase II study focuses on patients with high-risk spinal metastases, aiming to understand the effects of this less invasive treatment approach compared to traditional surgical options. Participants receive SBRT targeted specifically to spine metastases. The study involves a single treatment group where this precise radiation therapy is administered to up to three adjacent vertebral bodies affected by metastatic solid tumors. This approach is designed to manage the cancer spread while preserving neurologic function and avoiding more invasive procedures. During the study, participants undergo assessments including imaging and various disability and quality-of-life questionnaires at one, three, and six months after treatment. Researchers monitor the need for spinal surgery or stabilization within six months, changes in tumor volume, physical disability scores, quality of life, progression-free survival, and overall survival. The total follow-up period extends to six months to evaluate these outcomes and the safety of the SBRT treatment.
CONDITIONS
Brief Title
Definitive Radiation for High-Risk Spine Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pathologically confirmed solid tumor diagnosis not originating from the central nervous system with evidence of metastatic disease
- Imaging confirming metastatic involvement of the spine
- Metastases involving no more than three contiguous vertebral bodies at the target site
- Intact neurological function or minor deficits with muscle strength of 4 out of 5 or greater, with or without steroids
- Evaluation completed by radiation oncology and orthopedic spine or neurosurgery specialists
- ECOG performance status between 0 and 3
You will not qualify if you...
- Unstable spine defined by a Spinal Instability Neoplastic Score (SINS) greater than 12
- Previous surgery or radiation to the target spinal metastases
- Radiosensitive tumors such as small cell lung cancer, lymphoma, multiple myeloma, or germ-cell tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session
Participants receive stereotactic body radiation therapy (SBRT) administered to spine metastases.
1 treatment visit (in-person)
Duration - 6 months
Participants are monitored for outcomes including spinal surgery incidence, tumor volume reduction, disability changes, and survival up to 6 months after treatment.
Multiple follow-up visits at 1 month, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
Research Team
H
Hermina Munoz, RN
L
Lucia Joya
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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