Increased Early Pain Relief by Adding Vertebroplasty to SBRT

NCT05317026 | Recruiting

• 1 other identifier: 2022-10542
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Pain change at 1 month

  Visual Analogue Scale, from 0 to 10, 10 being the highest pain

  1 month following the treatment

Secondary Outcomes (5)

• Pain change

  1 week, 1 month, 3 months and 6 months post treatment

• Change in level of physical, psychological and social functions

  at 1 week, 1 month, 3 months and 6 months post treatment

• Change in symptoms related to bone metastasis

  at 1 week, 1 month, 3 months and 6 months post treatment

• Change in performance for activities of daily living

  at 1 week, 1 month, 3 months and 6 months post treatment

• Post-treatment fracture rates

  at 3, 6, 12 and 24 months post treatment

Study Arms (2)

V-SBRT

EXPERIMENTAL

Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)

Procedure: Vertebroplasty

SBRT

OTHER

SBRT is the actual standard of care.

Procedure: Stereotactic Body Radiation Therapy only

Interventions

Vertebroplasty 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.

V-SBRT

Stereotactic Body Radiation Therapy only PROCEDURE

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

Also known as: SBRT

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (2)

CHUM

Montreal, Quebec, H2X0C1, Canada

RECRUITING

Véronique Freire

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Vertebroplasty

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Véronique Freire, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Freire, MD

CONTACT

514-890-8000; veronique.freire.med@ssss.gouv.qc.ca

Fidaa Al-Shakfa, M.sc.

CONTACT

514-890-8000; f.alshakfa.crchum@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 7, 2022
• Study Start: November 22, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

CA (2)