Increased Early Pain Relief by Adding Vertebroplasty to SBRT

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Spine Metastases; Radiation Therapy
• Intervention / Treatment: Procedure: Vertebroplasty; Procedure: Stereotactic Body Radiation Therapy only

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Véronique Freire, MD; Phone Number: 514-890-8000; Email: veronique.freire.med@ssss.gouv.qc.ca
• Study Contact Backup: Name: Fidaa Al-Shakfa, M.sc.; Phone Number: 514-890-8000; Email: f.alshakfa.crchum@gmail.com

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X0C1
      • Recruiting
      • CHUM
      • Contact: Veronique Freire, MD; Phone Number: 514-883-6154; Email: veronique.freire.med@ssss.gouv.qc.ca
      • Contact: Mom PHAT; Phone Number: 11171 514 890-8000
    • Montréal, Quebec, Canada
      • Recruiting
      • Véronique Freire
      • Contact: Véronique Freire, MD
      • Sub-Investigator: Laura Masucci, MD
      • Sub-Investigator: David Donath, MD
      • Sub-Investigator: David Roberge, MD
      • Sub-Investigator: Taussky Daniel, MD
      • Sub-Investigator: Shedid Daniel, MD
      • Sub-Investigator: Sung-Joo Yuh, MD
      • Sub-Investigator: Zhi Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V-SBRT; Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)	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.
Other: SBRT; SBRT is the actual standard of care.	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; Other Names: SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain change at 1 month	Visual Analogue Scale, from 0 to 10, 10 being the highest pain	1 month following the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Post-treatment fracture rates	evaluation by MRI +/- CT imaging	at 3, 6, 12 and 24 months post treatment
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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Véronique Freire, MD, Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 2022-10542

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No