Same-day treatment for spinal metastases
Stereotactic Body Radiotherapy and pedicLE Screw fixatioN During One Hospital Visit for Patients With Painful Unstable Spinal Metastases: A Randomized Trial (BLEND)
This study tests if giving patients with painful spinal cancer both surgery and radiation on the same day can help them feel better and recover faster compared to the usual treatment of surgery followed by radiation later.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | Bevacizumab |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT05575323 on ClinicalTrials.gov |
What this trial studies
The BLEND RCT evaluates the effectiveness of providing same-day stereotactic body radiotherapy (SBRT) and surgical stabilization for patients with symptomatic, unstable spinal metastases. This approach aims to reduce the time between surgery and radiotherapy, potentially leading to quicker pain relief and faster recovery. The study compares this method to the standard care of surgery followed by conventional radiotherapy after wound healing. It is a phase II randomized controlled trial within a larger cohort focused on bone metastases.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic spinal metastases requiring surgical stabilization and radiotherapy.
Not a fit: Patients with conditions that prevent SBRT delivery or those with multiple myeloma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved physical functioning and quicker recovery for patients with spinal metastases.
How similar studies have performed: Other studies have shown promise in using same-day treatments for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic (cervical, thoracic and/or lumbar) spinal metastases from solid tumors and (impending) spinal instability requiring radiotherapy and surgical decompression and/or 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 * Routine surgical decompression and/or stabilization and radiotherapy cannot be performed, e.g., multiple spinal metastases requiring surgical bridging of more than five vertebral levels and/or requiring radiotherapy on more than one location * Prior surgery or radiotherapy to the index level(s) * Multiple myeloma * Neurological deficits (ASIA C, B or A), or partial neurological deficits (ASIA D) with rapid progression (hours to days) * Treated with Bevacizumab and other medication with long half-life that interferes with radiotherapy * Life expectancy of less than 3 months
Where this trial is running
Utrecht
- University Medical Center Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Helena M. Verkooijen, Prof — UMC Utrecht
- Study coordinator: Roxanne Gal, PhD
- Email: R.Gal@umcutrecht.nl
- Phone: +31 88 75 69624
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.