Definitive Radiation for High-Risk Spine Metastases
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
| Condition(s) | Metastatic Cancer, Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Tumor, Metastatic Tumor of Bone, Metastatic Tumor to the Spine, Spine Metastases, Metastasis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Stony Brook University |
| Locations | Stony Brook, New York, United States |
| Start date | 2023-12-14 |
| NCT ID | NCT06165419 |
| Official listing | https://clinicaltrials.gov/study/NCT06165419 |