Clinical trial · Interventional
Stereotactic Body Radiotherapy Followed by Surgical Stabilization in Spinal Metastases
Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases: Cohort Study According to the IDEAL Recommendations
NCT05060653CI-TRIAL-00066525BLEND-IIwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Alternative study was set up
Summary
Brief summary (as posted)
The aim of this study is to assess pain response after 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 (4)
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 | — |
| Radiosurgery | — | UNRESOLVED | — |
| Spinal Neoplasms | Spinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT followed by surgical stabilization within 24-48 hours | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT followed by surgical stabilization within 48 hours
- description
- SBRT and surgical stabilization will be performed within a 24 to 48-hour time window instead of today's standard of care of two weeks between surgical stabilization and conventional radiotherapy.
- interventionNames
- Other: SBRT followed by surgical stabilization within 24-48 hours
Primary outcomes (1)
- measure
- Pain response
- timeFrame
- 4 weeks
- description
- Pain response is defined as a decrease in initial worst pain score by at least 2 points on a Numeric Rating Scale (NRS) of 10 at the treated site, without increase in analgesic use, or an analgesic decrease of at least 25% without an increase in pain score
Secondary outcomes (6)
- measure
- Duration of pain relief
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participation in PRESENT cohort * Painful radiosensitive metastases from solid tumors in the cervical, thoracic or lumbar spine needing surgical stabilization * Histologic proof of malignancy or radiographic/clinical characteristics indicating malignancy beyond reasonable doubt * Radiographic evidence of spinal metastases * Fit for (radio)surgery * Age \> 18 years at the time of given informed consent in the PRESENT cohort. * Written informed consent Exclusion Criteria: * SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain * Surgery cannot be performed, e.g. in patients with multiple spinal metastases that cannot be bridged * Previous surgery or radiotherapy to index lesion * Neurological deficits (ASIA C, B or A) * Partial neurological deficits (ASIA D) with rapid progression (hours to days) * Non-ambulatory patients * Patient in hospice or with \< 3 months life expectancy * Medically inoperable or patient refused surgery * Radiosensitizing systemic treatment that cannot reasonably be stopped (for example immunotherapy and EGFR inhibitors)
References
Publications (0)
Data not yet available
No reference posted for this study.