Actively Recruiting
Led by UMC Utrecht · Updated on 2026-05-08
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
U
UMC Utrecht
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
Researchers are evaluating the (cost-)effectiveness of delivering same-day stereotactic body radiotherapy (SBRT) combined with surgical stabilization, with or without decompression, for patients who have symptomatic, unstable spinal metastases. The goal is to improve physical functioning four weeks after starting treatment compared to the current standard approach, which involves surgery followed by radiotherapy after sufficient wound healing. This randomized controlled trial is conducted within a cohort of patients with bone metastases and focuses on those with cervical, thoracic, or lumbar spinal metastases requiring intervention. The trial compares two groups: one receiving high-dose single-fraction SBRT targeted to the metastasis followed by surgical stabilization within 24 hours, and the other receiving standard care where surgical stabilization is followed by conventional radiotherapy or SBRT after the wound has healed adequately. Both groups may have decompression during surgery if needed. The study uses advanced radiotherapy techniques to protect soft tissues and aims to shorten the time between surgery and radiotherapy, potentially reducing hospital visits and allowing quicker pain relief and return to systemic treatment. Participants will be closely monitored through assessments of physical functioning at four weeks, pain response and duration, hospital stay length, neurological status, quality of life, adverse events, and survival outcomes up to 12 months. The study also evaluates cost-effectiveness. Researchers collect data at multiple timepoints including 2, 4, 6, and 8 weeks, as well as 3, 6, and 12 months after treatment starts. Participants are followed comprehensively to gather information on recovery, treatment side effects, and overall health impact.
CONDITIONS
Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive stereotactic body radiotherapy (SBRT) and surgical stabilization with or without decompression within 24 hours, or undergo surgical stabilization followed by conventional radiotherapy or SBRT after wound healing.
Hospital stay and treatment visits within 24 hours; follow-up visits for assessment up to 3 months
Duration - Up to 12 months
Participants are monitored for pain response, quality of life, adverse events, neurological status, and survival outcomes after treatment.
Visits at 2, 4, 6, and 8 weeks; and at 3, 6, and 12 months post-treatment
Total: 1 location
1
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
R
Roxanne Gal, PhD
E
Eline Huele, MSc
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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E H Huele, J M van der Velden, N Kasperts...
https://pubmed.ncbi.nlm.nih.gov/37143158