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

Online since 30 December 2023, updated 173 days ago

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 physic...

Included participants

Gender
All
Age
≥ 18 years
Injury level
Level not specified
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    Level not specified

    What’s involved

    Type

    Observational

    Details

    Rationale: Currently, patients with unstable spinal metastases receive surgical stabilization with/without decompression followed by conventional radiotherapy (cRT) or stereotactic body radiotherapy (SBRT) as soon as wound healing allows (at least 1 week). Advancements in radiotherapy techniques makes preoperative radiotherapy possible with sparing of the soft tissues overlying the surgical field. This makes it possible to shorten or even eliminate the time interval between surgery and radiotherapy. This will result in shorter and less hospital visits, earlier pain relief from irradiation, and faster return to systemic therapy without an increase in wound complications due to the short interval between surgery and radiotherapy. Objective: The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgery for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of the treatment, compared with the standard of care (surgery followed by radiotherapy, i.e., CRT or SBRT). Study design: A phase II randomized controlled trial within the PRospective Evaluation of interventional StudiEs on boNe metastases (PRESENT) cohort including patients with bone metastases, according to the Trials within Cohorts (TwiCs) design. Study population: Patients with symptomatic (cervical, thoracic and/or lumbar) spinal metastases and impending spinal instability requiring radiotherapy and surgical stabilization with or without decompression. Intervention: SBRT (with active dose-sparing of the surgical site) and surgical stabilization with or without decompression within 24 hours. The control group will receive the standard of care, which is surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently. Main study endpoints: The primary endpoint is physical functioning at four weeks after the start of the treatment. Secondary endpoints are pain response, duration of pain relief, length of hospital stay, time to return to systemic therapy, neurological deterioration, adverse events (e.g. wound complications), quality of life and survival. In addition, we will study the cost-effectiveness.

    Potential benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Oct 2022
    • Organisation
    • UMC Utrecht
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Oct 2022
    • Organisation
    • UMC Utrecht

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more