Clinical trial · Interventional
Stereotactic Radiosurgery in Treating Patients With Spinal Metastases
Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
NCT00853528CI-TRIAL-00028685completedPhase 1ClinicalTrials.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)
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diffusion tensor imaging | Procedure | — | UNRESOLVED |
| functional magnetic resonance imaging | Procedure | — | UNRESOLVED |
| hypo-fractionated SRS | Radiation | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| single-fraction SRS | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Single-fraction radiosurgery; 16 Gray
- description
- Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
- interventionNames
- Other: questionnaire administration
- Procedure: diffusion tensor imaging
- Procedure: functional magnetic resonance imaging
- Radiation: single-fraction SRS
- type
- EXPERIMENTAL
- label
- Hypo-fractionated radiosurgery; 21 Gray
- description
- Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic spinal tumor
* Localized spinal metastasis, defined as one of the following:
* Solitary spinal metastasis
* Two contiguous spinal levels
* No more than 2 adjacent spinal levels involved by a single tumor
* Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)
* Tumor size ≤ 5 cm
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Life expectancy ≥ 6 months
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be ambulatory
Exclusion Criteria:
* Not pregnant or nursing
* No spinal instability
* No rapid neurological decline
* No bony retropulsions causing neurological abnormalities
* No total paraplegia for \> 48 hours
* No psychological issues that would preclude completion of study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields
* No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance
* No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)References
Publications (0)
Data not yet available
No reference posted for this study.