Increased Early Pain Relief by Adding Vertebroplasty to SBRT
- Conditions
- Radiation TherapyPainSpine Metastases
- Interventions
- Procedure: VertebroplastyProcedure: Stereotactic Body Radiation Therapy only
- Registration Number
- NCT05317026
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Brief Summary
The goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Histological evidence of cancer.
- Spinal and vertebral bone metastases (T5 to L5) documented by imaging.
- Pain related to metastases ≥ 4 on a numerical scale 0-10.
- Karnofsky performance index > 60 (ecog 0-2)
- Candidate for SBRT
- Less than 3 consecutive levels reached.
- Ability to complete follow-up questionnaires regarding pain, analgesics, and quality of life assessment.
- Potentially unstable lesions according to the spinal instability neoplastic score (SINS) scale (> or = 7)
- Pregnancy or breastfeeding.
- Contraindications to MRI.
- Histology: myeloma, lymphoma or plasmacytoma.
- Radiotherapy prior to the level to be treated.
- Previous surgery at the site to be treated.
- Surgical indication:
spinal instability neoplastic score (SINS) > 13 or according to tumor board consensus.
Bilsky score > or = 2 Severe or progressive neurological signs (motor, incontinence).
- Lesion too large for safe vertebroplasty.
- High thoracic location not allowing safe visibility in fluoroscopy to perform vertebroplasty (T4 and above).
- Non-reversible coagulation disorders.
- Uncontrolled local or systemic infection.
- Estimated survival of less than 6 months.
- Inability or refusal to undergo SBRT treatment or vertebroplasty
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V-SBRT Vertebroplasty Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT) SBRT Stereotactic Body Radiation Therapy only SBRT is the actual standard of care.
- Primary Outcome Measures
Name Time Method Pain change at 1 month 1 month following the treatment Visual Analogue Scale, from 0 to 10, 10 being the highest pain
- Secondary Outcome Measures
Name Time Method Pain change 1 week, 1 month, 3 months and 6 months post treatment Visual Analogue Scale, from 0 to 10, 10 being the highest pain
Change in level of physical, psychological and social functions at 1 week, 1 month, 3 months and 6 months post treatment EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life)
Change in performance for activities of daily living at 1 week, 1 month, 3 months and 6 months post treatment Karnofsky performance scale (score from 0 to 100, the lower the Karnofsky score, themore disable the patient is and need assistance)
Change in symptoms related to bone metastasis at 1 week, 1 month, 3 months and 6 months post treatment QLQ-Bone metastases : BM22 questionnaire (All of the scales range in score from 0 to 100. A high score for the symptom scales represents a high level of symptomatology or problems, whilst a high score for the functional scales represents a high level of functioning)
Post-treatment fracture rates at 3, 6, 12 and 24 months post treatment evaluation by MRI +/- CT imaging
Trial Locations
- Locations (2)
CHUM
🇨🇦Montréal, Quebec, Canada
Véronique Freire
🇨🇦Montréal, Quebec, Canada