Comparing Vertebroplasty Plus Stereotactic Body Radiation Therapy to Radiation Therapy Alone for Pain Relief in Spine Metastases
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-08-07
50
Participants Needed
2
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying patients with spine metastases to evaluate whether adding vertebroplasty before stereotactic body radiation therapy SBRT can provide better early pain relief compared to SBRT alone. The study aims to understand if this combined approach reduces fractures and post-treatment pain, as the benefit of vertebroplasty before radiotherapy is not well documented. The trial is led by the Centre hospitalier de lUniversit de Montral CHUM and involves patients suitable for SBRT treatment with specific spinal metastases and pain levels.
Participants are randomly assigned to one of two groups. One group receives vertebroplasty followed by SBRT, while the other group receives only SBRT, which is the current standard care. Vertebroplasty involves injecting cement into the affected vertebrae under local anesthesia with imaging guidance, followed by a short recovery and same-day discharge. SBRT delivers precise radiotherapy in 1 to 5 treatment sessions targeting the metastatic spine lesions.
During the study, participants will be monitored for changes in pain at 1 week, 1 month, 3 months, and 6 months after treatment. Researchers will also assess physical, psychological, and social function changes, symptoms related to bone metastasis, and ability to perform daily activities. Fracture rates will be tracked up to 24 months post-treatment. Participants will complete questionnaires on pain and quality of life, and their overall health and safety will be observed throughout the trial period.
CONDITIONS
Brief Title
Increased Early Pain Relief by Adding Vertebroplasty to SBRT
Research Team
V
Véronique Freire, MD
F
Fidaa Al-Shakfa, M.sc.
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Histological evidence of cancer
Spinal and vertebral bone metastases (T5 to L5) documented by imaging
Pain related to metastases 4 or higher on a 0-10 scale
Karnofsky performance index greater than 60 (ECOG 0-2)
Candidate for stereotactic body radiation therapy (SBRT)
Less than 3 consecutive vertebral levels affected
Ability to complete follow-up questionnaires on pain, analgesics, and quality of life
Potentially unstable lesions with spinal instability neoplastic score (SINS) of 7 or more
You will not qualify if you...
Pregnancy or breastfeeding
Contraindications to MRI
Histology of myeloma, lymphoma, or plasmacytoma
Prior radiotherapy at the treatment level
Previous surgery at the treatment site
Surgical indication with SINS score greater than 13 or per tumor board consensus
Bilsky score 2 or higher with severe or progressive neurological symptoms
Lesion too large for safe vertebroplasty
High thoracic location (T4 and above) preventing safe fluoroscopic visibility
Non-reversible coagulation disorders
Uncontrolled local or systemic infection
Estimated survival less than 6 months
Inability or refusal to undergo SBRT or vertebroplasty treatment
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Radiotherapy treatments in 1 to 5 fractions; vertebroplasty on a single day with same-day discharge
Participants receive vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT) or SBRT alone as part of the treatment for spine metastases.
1 vertebroplasty procedure visit and up to 5 SBRT treatment visits
Follow-up
Duration - Up to 24 months post treatment
Participants are monitored for pain relief, physical and psychological function, symptoms related to bone metastasis, daily living activities, and fracture rates after treatment.
Assessments at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months post treatment
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Evaluating 18F-Fluciclovine PET and MRI Imaging to Detect Tumors in Adults with Brain Metastases Undergoing Immunotherapy and Radiation
Study of Mixed Reality Cognitive Distraction Therapy for Adults with Chronic Pain
A Multicenter, Randomized, Single-Blind Clinical Trial
Study Comparing Combined Manual Therapy and Vagus Nerve Stimulation to Manual Therapy Alone for Adults with Myogenic Temporomandibular Joint Disorders
Phase 1 Study of TT5 to Evaluate Safety and Pharmacokinetics in Healthy Adults and Surgical Patients Using Single and Multiple Intravenous Doses
Testing the Grasp Handheld Device to Reduce Pain and Distress in Children and Teens During Needle Procedures
Longitudinal Multi-center Study on Neuropathic Pain and Brain Function in Adults
Psychosocial Therapy to Improve Memory, Depression, and Pain in Older Adults with Mild Cognitive Impairment or Early Alzheimers
Study of Live and Recorded Music Effects on Stress, Mood, Pain, and Biomarkers in Neurosurgery Patients
Phase 2 Study of Enalapril for Adults Aged 18 to 70 With Painful Venous Malformations to Reduce Pain and Improve Quality of Life
Phase 1 Study of Safety and Effects of HRS-6257 Drug in Healthy Adults Aged 18 to 55
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation.