Radiation treatment for high-risk spine cancer patients
Official title: A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases
Run by Stony Brook University · NCT06165419 · Data updated 2026-11-12
This study is testing a new type of radiation treatment for patients with cancer that has spread to the spine to see if it can help manage their condition without needing major surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Stony Brook University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Stony Brook, New York) |
| Status | Recruiting |
| Started | December 14, 2023 |
| Main results expected | May 31, 2026 |
| Study ends | May 31, 2026 |
| Registry record updated | May 14, 2025 |
| Trial ID | NCT06165419 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with solid tumors that have metastasized to the spine, with intact neurologic function and specific imaging criteria.
✕Probably not a fit
Patients with unstable spine conditions or those who have previously undergone surgery or radiation for the same spinal metastases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of stereotactic body radiation therapy (SBRT) as a treatment for patients with metastatic cancer that has spread to the spine. The goal is to determine if this non-invasive approach can effectively manage spine metastases without the need for extensive surgical intervention. Eligible participants will have documented metastatic spine involvement and will be evaluated by both radiation oncology and orthopedic spine/neurosurgery specialists. The study aims to provide a less invasive treatment option for patients with specific criteria.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive alternative to surgery for patients with high-risk spine metastases.
How similar studies have gone: Other studies have shown promising results with stereotactic body radiation therapy for similar conditions, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Stony Brook University Hospital
Stony Brook, New York, United States Recruiting
Study contacts
- Principal investigator: Kartik Mani, MD PhD — Stony Brook Cancer Center
- Study coordinator: Hermina Munoz, RN
- Email: hermina.munoz@stonybrookmedicine.edu
- Phone: 631-216-2990
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.