Actively Recruiting
A Phase II Randomized Trial of Combined Radiotherapy and Vertebroplasty to Improve the Quality of Life of Patients With Painful Metastatic Localized Spinal Lesions
Led by AHS Cancer Control Alberta · Updated on 2025-06-26
64
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
A
AHS Cancer Control Alberta
Lead Sponsor
C
Cross Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with painful spinal metastases to evaluate whether combining vertebroplasty with radiotherapy can provide better pain relief, spine stabilization, and tumor control compared to radiotherapy alone. This phase II randomized trial aims to determine if this combined approach can reduce the need for opioids and prevent vertebral compression fractures, potentially improving quality of life for patients with spinal metastases. Participants are randomly assigned to one of two treatment groups: radiotherapy alone or vertebroplasty followed by radiotherapy within 2 to 3 weeks. Radiotherapy doses are either 20 Gy given in 5 fractions over 1 week or a single 8 Gy fraction, decided by the radiation oncologist. Vertebroplasty is a procedure where bone cement is injected into fractured vertebrae to stabilize the spine. During the study, participants will be monitored at 1, 3, 6, and 12 months after treatment to assess pain levels using the Visual Analog Scale and Brief Pain Inventory. Researchers will also evaluate back-specific physical function and the occurrence of vertebral compression fractures. The study includes follow-up imaging at baseline, 6 months, and 12 months. Participants are expected to comply with scheduled visits, treatments, and assessments throughout the study period.
CONDITIONS
Brief Title
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants capable of giving informed consent or having an acceptable individual to consent on their behalf
- Patients 18 years of age or older
- Spinal vertebral metastases confirmed by CT, MRI, or bone scan
- Painful vertebral spinal metastases in the thoracic and/or lumbar spine with a Visual Analog Scale pain score of at least 2
- Willing and able to comply with scheduled visits, treatment plan, tests, and study procedures
- Life expectancy greater than 6 months, assessed clinically and by the Linden model (group B or C)
- ECOG performance status 0-2 or Karnofsky score of 60% or higher
- No prior external beam radiotherapy to the target vertebral body or adjacent levels
- Women of childbearing potential must have a negative pregnancy test and meet menopause criteria if applicable
- Use highly effective birth control during treatment if of reproductive potential
- Females must not breastfeed during study treatment
- Male patients must agree not to donate sperm during study treatment
- No conditions that would hamper compliance with study protocols and follow-up
You will not qualify if you...
- Unable to provide consent
- Prior radiotherapy to the target vertebral body or adjacent levels
- Life expectancy less than 6 months
- Karnofsky performance status below 60%
- Presence of primary bone tumors
- Diagnosis of plasmacytoma
- Communicated vertebral fractures
- Impending or actual spinal cord compression
- Epidural involvement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Radiotherapy is delivered over 1 week; vertebroplasty occurs prior to radiotherapy within 2 to 3 weeks.
Participants receive either radiotherapy alone or vertebroplasty followed by radiotherapy to treat painful metastatic spinal lesions.
1 procedure visit for vertebroplasty (if assigned) and up to 5 radiotherapy sessions over 1 week
Duration - Up to 12 months post treatment
Participants are monitored to assess pain improvement and physical functioning after treatment.
Visits at 1, 3, 6, and 12 months post treatment
Trial Site Locations
Total: 1 location
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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