Increased Early Pain Relief by Adding Vertebroplasty to SBRT

Recruiting now · Not applicable

Conditions studied: Spine Metastases, Radiation Therapy, Pain

In brief

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.

Key facts

Study ID

NCT05317026

Run by

Centre hospitalier de l'Université de Montréal (CHUM)

People needed

50

Starts

2023-11-22

Expected to finish

2027-12-31

Last updated by the study team

2024-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• CHUM — Montreal, Quebec, Canada (enrolling)
• Véronique Freire — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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