Clinical trial NCT05317026: Increased Early Pain Relief by Adding Vertebroplasty to SBRT
Official title: Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spine Metastases
Radiation Therapy
Pain
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain change at 1 month
timeFrame: 1 month following the treatment
Secondary outcomes:
measure: Pain change
timeFrame: 1 week, 1 month, 3 months and 6 months post treatment
measure: Change in level of physical, psychological and social functions
timeFrame: at 1 week, 1 month, 3 months and 6 months post treatment
measure: Change in symptoms related to bone metastasis
timeFrame: at 1 week, 1 month, 3 months and 6 months post treatment
measure: Change in performance for activities of daily living
timeFrame: at 1 week, 1 month, 3 months and 6 months post treatment
measure: Post-treatment fracture rates
timeFrame: at 3, 6, 12 and 24 months post treatment
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
city: Montréal
country: Canada
facility: Véronique Freire
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Véronique Freire, MD
role: PRINCIPAL_INVESTIGATOR
References: