Increased Early Pain Relief by Adding Vertebroplasty to SBRT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Pregnancy or breastfeeding.
Contraindications to MRI.
Histology: myeloma, lymphoma or plasmacytoma.
Radiotherapy prior to the level to be treated.
Trial design
Design model
Parallel
Treatments tested in this trial
Vertebroplasty
Procedure/SurgerySBRT 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/SurgerySBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: V-SBRTExperimental treatment 1 intervention
Group B: SBRTOther 1 intervention
Trial outcomes
Primary outcomes
1
Pain change at 1 month
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
Time frame
1 month following the treatmentSecondary outcomes
1
Pain change
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
Time frame
1 week, 1 month, 3 months and 6 months post treatment2
Change in level of physical, psychological and social functions
EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life)
Time frame
at 1 week, 1 month, 3 months and 6 months post treatment3
Change in symptoms related to bone metastasis
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)
Time frame
at 1 week, 1 month, 3 months and 6 months post treatment4
Change in performance for activities of daily living
Karnofsky performance scale (score from 0 to 100, the lower the Karnofsky score, themore disable the patient is and need assistance)
Time frame
at 1 week, 1 month, 3 months and 6 months post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov