Combining vertebroplasty with radiation therapy for spine metastases pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of adding vertebroplasty to stereotactic body radiation therapy (SBRT) for patients with spinal metastases. The primary goal is to enhance pain relief and reduce the risk of fractures in patients receiving SBRT. Participants will be evaluated for pain levels and quality of life following the interventions. The study aims to determine if vertebroplasty performed before SBRT can lead to better outcomes compared to SBRT alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Chum
  Montreal, Quebec, Canada Recruiting
• Véronique Freire
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Véronique Freire, MD — Centre hospitalier de l'Université de Montréal (CHUM)
• Study coordinator: Véronique Freire, MD
• Email: veronique.freire.med@ssss.gouv.qc.ca
• Phone: 514-890-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.