Increased Early Pain Relief by Adding Vertebroplasty to SBRT

Pain Clinical Trial

Official title:

Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317026
• Other study ID #: 2022-10542
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Véronique Freire, MD
• Phone: 514-890-8000
• Email: veronique.freire.med[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2026
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Pain
• Radiation Therapy
• Spine Metastases

Intervention

Procedure:
• 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.
• 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

Locations

Country	Name	City	State
Canada	CHUM	Montréal	Quebec
Canada	Véronique Freire	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain change at 1 month	Visual Analogue Scale, from 0 to 10, 10 being the highest pain	1 month following the treatment
Secondary	Pain change	Visual Analogue Scale, from 0 to 10, 10 being the highest pain	1 week, 1 month, 3 months and 6 months post treatment
Secondary	Change in level of physical, psychological and social functions	EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life)	at 1 week, 1 month, 3 months and 6 months post treatment
Secondary	Change in symptoms related to bone metastasis	QLQ-Bone metastases : BM22 questionnaire (All of the scales range in score from 0 to 100. A high score for the symptom scales represents a high level of symptomatology or problems, whilst a high score for the functional scales represents a high level of functioning)	at 1 week, 1 month, 3 months and 6 months post treatment
Secondary	Change in performance for activities of daily living	Karnofsky performance scale (score from 0 to 100, the lower the Karnofsky score, themore disable the patient is and need assistance)	at 1 week, 1 month, 3 months and 6 months post treatment
Secondary	Post-treatment fracture rates	evaluation by MRI +/- CT imaging	at 3, 6, 12 and 24 months post treatment