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Recruiting NCT05317026

Increased Early Pain Relief by Adding Vertebroplasty to SBRT

No phase Interventional Spine Metastases Radiation Therapy Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vertebroplasty, Stereotactic Body Radiation Therapy only.
Who it may be relevant to
Registry conditions: Spine Metastases, Radiation Therapy, Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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
  • 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

Primary outcome measures

  • Pain change at 1 month [Time frame: 1 month following the treatment]
Secondary outcome measures (5)
  • Pain change [Time frame: 1 week, 1 month, 3 months and 6 months post treatment]
  • Change in level of physical, psychological and social functions [Time frame: at 1 week, 1 month, 3 months and 6 months post treatment]
  • Change in symptoms related to bone metastasis [Time frame: at 1 week, 1 month, 3 months and 6 months post treatment]
  • Change in performance for activities of daily living [Time frame: at 1 week, 1 month, 3 months and 6 months post treatment]
  • Post-treatment fracture rates [Time frame: at 3, 6, 12 and 24 months post treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • CHUM — Montreal
  • Véronique Freire — Montreal

Publications

  • Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0. PMID 42032732

Identifiers

NCT: NCT05317026 · 2022-10542

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗