NCT05575323 Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
| NCT ID | NCT05575323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Spinal Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-10-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-10-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgical stabilization with or without decompression for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of treatment, compared with the standard of care (surgery followed by radiotherapy as soon as the wound healed sufficiently).
Eligibility 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
Contact & Investigator
Helena M. Verkooijen, Prof
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT05575323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05575323 currently recruiting?
Yes, NCT05575323 is actively recruiting participants. Contact the research team at R.Gal@umcutrecht.nl for enrollment information.
Where is the NCT05575323 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT05575323 clinical trial?
NCT05575323 is sponsored by UMC Utrecht. The principal investigator is Helena M. Verkooijen, Prof at UMC Utrecht. The trial plans to enroll 100 participants.