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Increased Early Pain Relief by Adding Vertebroplasty to SBRT

Primary Purpose

Spine Metastases, Radiation Therapy, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vertebroplasty
Stereotactic Body Radiation Therapy only
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spine Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHUMRecruiting
  • Véronique FreireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

V-SBRT

SBRT

Arm Description

Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)

SBRT is the actual standard of care.

Outcomes

Primary Outcome Measures

Pain change at 1 month
Visual Analogue Scale, from 0 to 10, 10 being the highest pain

Secondary Outcome Measures

Pain change
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
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)
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)
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)
Post-treatment fracture rates
evaluation by MRI +/- CT imaging

Full Information

First Posted
March 8, 2022
Last Updated
April 19, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT05317026
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
April 4, 2024 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Metastases, Radiation Therapy, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V-SBRT
Arm Type
Experimental
Arm Description
Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)
Arm Title
SBRT
Arm Type
Other
Arm Description
SBRT is the actual standard of care.
Intervention Type
Procedure
Intervention Name(s)
Vertebroplasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stereotactic Body Radiation Therapy only
Other Intervention Name(s)
SBRT
Intervention Description
SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume
Primary Outcome Measure Information:
Title
Pain change at 1 month
Description
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
Time Frame
1 month following the treatment
Secondary Outcome Measure Information:
Title
Pain change
Description
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
Time Frame
1 week, 1 month, 3 months and 6 months post treatment
Title
Change in level of physical, psychological and social functions
Description
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 treatment
Title
Change in symptoms related to bone metastasis
Description
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 treatment
Title
Change in performance for activities of daily living
Description
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 treatment
Title
Post-treatment fracture rates
Description
evaluation by MRI +/- CT imaging
Time Frame
at 3, 6, 12 and 24 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique Freire, MD
Phone
514-890-8000
Email
veronique.freire.med@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Fidaa Al-Shakfa, M.sc.
Phone
514-890-8000
Email
f.alshakfa.crchum@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Freire, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUM
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X0C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronique Freire, MD
Phone
514-883-6154
Email
veronique.freire.med@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Mom PHAT
Phone
514 890-8000
Ext
11171
Facility Name
Véronique Freire
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Freire, MD
First Name & Middle Initial & Last Name & Degree
Laura Masucci, MD
First Name & Middle Initial & Last Name & Degree
David Donath, MD
First Name & Middle Initial & Last Name & Degree
David Roberge, MD
First Name & Middle Initial & Last Name & Degree
Taussky Daniel, MD
First Name & Middle Initial & Last Name & Degree
Shedid Daniel, MD
First Name & Middle Initial & Last Name & Degree
Sung-Joo Yuh, MD
First Name & Middle Initial & Last Name & Degree
Zhi Wang, MD

12. IPD Sharing Statement

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Increased Early Pain Relief by Adding Vertebroplasty to SBRT

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