NL-OMON51812
Recruiting
Not Applicable
Stereotactic Body radiotherapy and pedicLE screw fixatioN During one hospital visit for patients with symptomatic unstable spinal metastases: A randomized trial (BLEND RCT) - BLEND RCT
niversitair Medisch Centrum Utrecht0 sites100 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptomatic (cervical, thoracic and/or lumbar) spinal metastases and
- •impending spinal instability requiring radiotherapy and surgical stabilization
- •Histologic proof of malignancy or radiographic/clinical characteristics
- •indicating malignancy beyond reasonable doubt
- •Radiographic evidence of spinal metastases
- •Participation in PRESENT cohort, including consent for randomization into
- •future trials
- •Fit for (radio)surgery
- •Age \>18 years
- •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., multiple spinal metastases requiring
- •surgical bridging of more than five vertebral levels
- •Prior surgery or radiotherapy to the index levels
- •Neurological deficits (ASIA C, B or A), or partial neurological deficits
- •(ASIA D) with rapid progression (hours to days)
- •Life expectancy of less than 3 months
Outcomes
Primary Outcomes
Not specified
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