Increased Early Pain Relief by Adding Vertebroplasty to SBRT

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Mar 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a procedure called vertebroplasty to a type of radiation treatment known as stereotactic body radiation therapy (SBRT) can help relieve pain more effectively for patients with spine metastases, which are cancerous growths in the spine. Currently, SBRT is the standard treatment for these patients, but researchers want to see if performing vertebroplasty first can not only reduce pain but also help prevent fractures in the spine.

To be eligible for the trial, participants should have a confirmed cancer diagnosis that has spread to the spine, experience significant pain related to the cancer, and be suitable candidates for SBRT. Participants must also be able to understand and answer follow-up questions about their pain and quality of life. Those who join the study can expect to receive either the SBRT treatment alone or the SBRT treatment along with vertebroplasty, and their progress will be monitored closely. It's important to note that some individuals, such as pregnant women or those with specific health issues, may not be able to participate in the trial.

Gender

ALL

Eligibility criteria

• 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