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New treatment option for Spinal Metastases
Official title Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
ClinicalTrials.gov ID: NCT05575323
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Symptomatic (cervical, thoracic and/or lumbar) spinal metastases from solid tumors and (impending) spinal instability requiring radiotherapy and...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.