NCT06165419RecruitingPhase 2
Definitive Radiation for High-Risk Spine Metastases
A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 1 Dec 2023
- Start date
- 14 Dec 2023
- Primary completion date
- 31 May 2026
- Lead sponsor
- Stony Brook University
- Diseases
- Lung cancer, Metastatic breast cancer
- NCT number
- NCT06165419
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 26
- From 14 Dec 2023 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stony Brook University Hospital Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.