Clinical trial · Interventional
Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases
Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases: First-in-Man Study According to the IDEAL Recommendations
NCT02622841CI-TRIAL-00027428BLENDcompletedPhase 1 / Phase 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)
The aim of this study is to assess the feasibility and safety of combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine.
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 |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BLEND | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BLEND
- description
- Combination of stereotactic bodyradiotherapy and surgical stabilization within 48 hours for the treatment of unstable spinal metastases.
- interventionNames
- Procedure: BLEND
Primary outcomes (1)
- measure
- Occurrence of adverse events
- timeFrame
- first 90 days post treatment
- description
- Occurrence of adverse events grade 3/4 according to the common terminology criteria for adverse events (CTCAE) 4.0
Secondary outcomes (8)
- measure
- Pain response
- timeFrame
- first 90 days post treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Painful metastases from solid tumors in the thoracic or lumbar spine needing surgical stabilization * Histologic proof of malignancy * Radiographic evidence of spinal metastases * Karnofsky performance status ≤ 50 * Written informed consent Exclusion Criteria: * Multiple spinal metastases necessitating bridging more than five vertebral levels during surgery * Previous surgery or radiotherapy to index lesion * stereotactic body radiotherapy cannot be delivered (Bilsky score 2 and 3) * Neurological deficits (ASIA C, B or A) * Partial neurological deficits (ASIA D) with rapid progression (hours to days) * Inability to lie flat on table for stereotactic body radiotherapy * Non-ambulatory patients * Patient in hospice or with \< 3 months life expectancy * Medically inoperable or patient refused surgery
References
Publications (0)
Data not yet available
No reference posted for this study.