Increased Early Pain Relief by Adding Vertebroplasty to SBRT

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Enrolling

Conditions: Radiation Therapy; Spine Metastases; Pain

Treatments: Procedure: Vertebroplasty; Procedure: Stereotactic Body Radiation Therapy only

Study type: Interventional

Funder types: Other

Identifiers

NCT05317026

2022-10542

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

V-SBRT

Experimental group

Description:

Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)

Treatment:

Procedure: Vertebroplasty

SBRT

Other group

Description:

SBRT is the actual standard of care.

Treatment:

Procedure: Stereotactic Body Radiation Therapy only