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NCT Number: NCT05317026

Increased Early Pain Relief by Adding Vertebroplasty to SBRT

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.

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Key information

Conditions

Spine Metastases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Radiation Therapy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUM, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vertebroplasty

Procedure

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

Procedure

SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume

Other names: SBRT

Primary outcomes

  1. Pain change at 1 month

    Time frame: 1 month following the treatment

    Visual Analogue Scale, from 0 to 10, 10 being the highest pain

Secondary outcomes

  1. Pain change

    Time frame: 1 week, 1 month, 3 months and 6 months post treatment

    Visual Analogue Scale, from 0 to 10, 10 being the highest pain

  2. Change in level of physical, psychological and social functions

    Time frame: at 1 week, 1 month, 3 months and 6 months post treatment

    EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life)

  3. Change in symptoms related to bone metastasis

    Time frame: at 1 week, 1 month, 3 months and 6 months post treatment

    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)

  4. Change in performance for activities of daily living

    Time frame: at 1 week, 1 month, 3 months and 6 months post treatment

    Karnofsky performance scale (score from 0 to 100, the lower the Karnofsky score, themore disable the patient is and need assistance)

  5. Post-treatment fracture rates

    Time frame: at 3, 6, 12 and 24 months post treatment

    evaluation by MRI +/- CT imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Fidaa Al-Shakfa, M.sc.

CONTACT

[email protected]

514-890-8000

Véronique Freire, MD

CONTACT

[email protected]

514-890-8000

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Apr 7, 2022
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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