Increased Early Pain Relief by Adding Vertebroplasty to SBRT

NCT ID: NCT05317026

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-22
• Study Completion Date: 2027-12-31

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.

Conditions

Spine Metastases; Radiation Therapy; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

V-SBRT

Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)

Group Type: EXPERIMENTAL

Vertebroplasty

Intervention Type: PROCEDURE

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.

SBRT

SBRT is the actual standard of care.

Group Type: OTHER

Stereotactic Body Radiation Therapy only

Intervention Type: PROCEDURE

SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume

Interventions

Vertebroplasty

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.

Intervention Type: PROCEDURE

Stereotactic Body Radiation Therapy only

SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume

Intervention Type: PROCEDURE

Other Intervention Names

SBRT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Véronique Freire, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

CHUM

Montreal, Quebec, Canada

Site Status: RECRUITING

Véronique Freire

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Véronique Freire, MD

Role: CONTACT

veronique.freire.med@ssss.gouv.qc.ca

514-890-8000

Fidaa Al-Shakfa, M.sc.

Role: CONTACT

f.alshakfa.crchum@gmail.com

514-890-8000

Facility Contacts

Veronique Freire, MD

Role: primary

veronique.freire.med@ssss.gouv.qc.ca

514-883-6154

Mom PHAT

Role: backup

514 890-8000 ext. 11171

Véronique Freire, MD

Role: primary

Other Identifiers

2022-10542

Identifier Type: -

Identifier Source: org_study_id