Increased Early Pain Relief by Adding Vertebroplasty to SBRT

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05317026
Collaborator
(none)
50
1
2
41.9
1.2

Study Details

Study Description

Brief Summary

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 (Jang and Lee 2005, Li, Qing et al 2015, Cao, Liu et al 2016, Wardak, Bland et al 2019).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Vertebroplasty
  • Procedure: Stereotactic Body Radiation Therapy only
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief
Anticipated Study Start Date :
Jul 4, 2022
Anticipated Primary Completion Date :
Aug 4, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Pain change at 1 month [1 month following the treatment]

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

    Secondary Outcome Measures

    1. Pain change [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 physicial, psychological and social functions [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 [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 [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 [at 3, 6, 12 and 24 months post treatment]

      evaluation by MRI +/- CT imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Véronique Freire Montréal Quebec Canada

    Sponsors and Collaborators

    • Centre hospitalier de l'Université de Montréal (CHUM)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Véronique Freire, Head of musculoskeletal imaging, Radiology Department, principal investigator, clinical associate professor, Centre hospitalier de l'Université de Montréal (CHUM)
    ClinicalTrials.gov Identifier:
    NCT05317026
    Other Study ID Numbers:
    • 2022-10542
    First Posted:
    Apr 7, 2022
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022