Definitive Radiation for High-Risk Spine Metastases
Recruiting · NCT06165419 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
SBRT to the spine
What this trial is about
This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
Eligible patients must have:
* Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease
* Metastatic spine involvement documented by imaging
* Involvement of maximum 3 contiguous vertebral bodies at the index site
* Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids
* An evaluation by an radiation oncology and orthopedic spine/neurosurgery attending
* ECOG Performance Status of 0-3
Patients are ineligible if they have:
* An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12
* Had previous surgery or radiation to address the target spinal metastases
* Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)
Where it is running
2 locations listed across 1 US state.
- Stony Brook University Hospital - Stony Brook, New York, United States
- Stony Brook University Hospital - Stony Brook, New York, United States