Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases

Launched by UMC UTRECHT · Oct 7, 2022

Keywords

ClinConnect Summary

The BLEND clinical trial is investigating a new treatment approach for patients with spinal metastases, which are cancerous tumors that have spread to the spine and can cause pain and instability. This study compares the effects of two different treatment methods: one that combines same-day surgery to stabilize the spine and targeted radiation therapy (called SBRT) and another that follows the standard practice of surgery first, followed by radiation therapy once the surgical wounds have healed. The goal is to see which method helps improve physical function better four weeks after treatment starts.

To participate in this trial, individuals must be at least 18 years old and have symptoms related to spinal metastases that require both surgery and radiation therapy. They should also have proof of cancer and be physically fit for these procedures. However, certain conditions, like having multiple spinal metastases or significant neurological issues, may exclude someone from participating. If eligible, participants can expect to receive either of the two treatment approaches and will be closely monitored for their progress. This trial is currently recruiting participants, and it aims to understand not just how effective these treatments are, but also how they might improve patients' quality of life.

Gender

ALL

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