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

ConditionSpinal Metastases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUMC Utrecht

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Same-day SBRT and spinal surgery
Standard of care

Treatment groups

100 Participants

are divided into 2 treatment groups

Sponsors and collaborators

UMC Utrecht

Lead sponsor

Radboud University Medical Center

Collaborator

Source ClinicalTrials.gov