Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05317026

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

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-08-07

50

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with spine metastases to evaluate whether adding vertebroplasty before stereotactic body radiation therapy (SBRT) can provide better early pain relief compared to SBRT alone. The study aims to understand if this combined approach reduces fractures and post-treatment pain, as the benefit of vertebroplasty before radiotherapy is not well documented. The trial is led by the Centre hospitalier de l'Université de Montréal (CHUM) and involves patients suitable for SBRT treatment with specific spinal metastases and pain levels. Participants are randomly assigned to one of two groups. One group receives vertebroplasty followed by SBRT, while the other group receives only SBRT, which is the current standard care. Vertebroplasty involves injecting cement into the affected vertebrae under local anesthesia with imaging guidance, followed by a short recovery and same-day discharge. SBRT delivers precise radiotherapy in 1 to 5 treatment sessions targeting the metastatic spine lesions. During the study, participants will be monitored for changes in pain at 1 week, 1 month, 3 months, and 6 months after treatment. Researchers will also assess physical, psychological, and social function changes, symptoms related to bone metastasis, and ability to perform daily activities. Fracture rates will be tracked up to 24 months post-treatment. Participants will complete questionnaires on pain and quality of life, and their overall health and safety will be observed throughout the trial period.

CONDITIONS

Brief Title

Increased Early Pain Relief by Adding Vertebroplasty to SBRT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological evidence of cancer
  • Spinal and vertebral bone metastases (T5 to L5) documented by imaging
  • Pain related to metastases 4 or higher on a 0-10 scale
  • Karnofsky performance index greater than 60 (ECOG 0-2)
  • Candidate for stereotactic body radiation therapy (SBRT)
  • Less than 3 consecutive vertebral levels affected
  • Ability to complete follow-up questionnaires on pain, analgesics, and quality of life
  • Potentially unstable lesions with spinal instability neoplastic score (SINS) of 7 or more
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Contraindications to MRI
  • Histology of myeloma, lymphoma, or plasmacytoma
  • Prior radiotherapy at the treatment level
  • Previous surgery at the treatment site
  • Surgical indication with SINS score greater than 13 or per tumor board consensus
  • Bilsky score 2 or higher with severe or progressive neurological symptoms
  • Lesion too large for safe vertebroplasty
  • High thoracic location (T4 and above) preventing safe fluoroscopic visibility
  • Non-reversible coagulation disorders
  • Uncontrolled local or systemic infection
  • Estimated survival less than 6 months
  • Inability or refusal to undergo SBRT or vertebroplasty treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Radiotherapy treatments in 1 to 5 fractions; vertebroplasty on a single day with same-day discharge

Participants receive vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT) or SBRT alone as part of the treatment for spine metastases.

1 vertebroplasty procedure visit and up to 5 SBRT treatment visits

Follow-up

Duration - Up to 24 months post treatment

Participants are monitored for pain relief, physical and psychological function, symptoms related to bone metastasis, daily living activities, and fracture rates after treatment.

Assessments at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months post treatment

Trial Site Locations

Total: 2 locations

1

CHUM

Montreal, Quebec, Canada, H2X0C1

Actively Recruiting

2

Véronique Freire

Montreal, Quebec, Canada

Actively Recruiting

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Research Team

V

Véronique Freire, MD

F

Fidaa Al-Shakfa, M.sc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation.

Philippe Giguère, Houda Bahig, Sydney Westra...

https://pubmed.ncbi.nlm.nih.gov/42032732