Clinical trial · Interventional
Definitive Radiation for High-Risk Spine Metastases
A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases
NCT06165419CI-TRIAL-00089628recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Tumor | Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Tumor of Bone | Bone Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Tumor to the Spine | — | UNRESOLVED | — |
| Spine Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT to the spine | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT to the spine
- interventionNames
- Radiation: SBRT to the spine
Primary outcomes (1)
- measure
- Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT
- timeFrame
- 6 months
- description
- Assess the efficacy of spine SBRT alone in controlling spine metastases
Secondary outcomes (6)
- measure
- Reduction in epidural tumor volume
- timeFrame
- 3 months
- description
- Percent reduction of epidural volume of the treated metastatic lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.