Increased Early Pain Relief by Adding Vertebroplasty to SBRT

Study Overview
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Brief Summary
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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.

Official Title
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Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief

Conditions
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Spine Metastases, Radiation Therapy, Pain

Intervention / Treatment
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* Procedure: Vertebroplasty
* Procedure: Stereotactic Body Radiation Therapy only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V-SBRT<br>Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT) | Procedure: Vertebroplasty<br>* SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume. The vertebroplasty will be performed according to the usual procedure at the center in the angiography suite under local anesthesia and conscious sedation Introduction of a vertebral needle, under biplanar fluoroscopic guidance, polymethylmethacrylate (PMMA) cement injection. Cone-beam volume-CT at the end of the procedure, with the angiography table and c-arm, to evaluate the cement distribution and detect any leak. Decubitus position for 2 hours following procedure, then hospital discharge on the same day.<br>|
| Other: SBRT<br>SBRT is the actual standard of care. | Procedure: Stereotactic Body Radiation Therapy only<br>* SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume<br>* Other names: SBRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain change at 1 month | Visual Analogue Scale, from 0 to 10, 10 being the highest pain | 1 month following the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain change | Visual Analogue Scale, from 0 to 10, 10 being the highest pain | 1 week, 1 month, 3 months and 6 months post treatment | 
| Change in level of physical, psychological and social functions | EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life) | at 1 week, 1 month, 3 months and 6 months post treatment | 
| Change in symptoms related to bone metastasis | 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) | at 1 week, 1 month, 3 months and 6 months post treatment | 
| Change in performance for activities of daily living | Karnofsky performance scale (score from 0 to 100, the lower the Karnofsky score, themore disable the patient is and need assistance) | at 1 week, 1 month, 3 months and 6 months post treatment | 
| Post-treatment fracture rates | evaluation by MRI +/- CT imaging | at 3, 6, 12 and 24 months post treatment |