Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04242589

Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions

Led by AHS Cancer Control Alberta · Updated on 2025-06-26

64

Participants Needed

1

Research Sites

347 weeks

Total Duration

On this page

Sponsors

A

AHS Cancer Control Alberta

Lead Sponsor

C

Cross Cancer Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Since patients with spinal metastases are living longer, durable palliation with long-term tumor control are becoming increasingly important. EBRT results in durable local control of bone metastasis. However, about 25 % of patients with spinal metastases only achieved complete pain relief following EBRT for a median duration of less than 4 months. This could be partly due to spinal instability. In addition, almost half of the patients who receive EBRT will subsequently develop VCFs . Hence, RT does not stabilize the spine secondary to VCFs and is not effective in preventing imminent VCFs. Vertebroplasty has rapidly reduced pain and improved function in patients with VCFs. However, vertebroplasty does not provide local tumor control similar to EBRT. It is theorized that combining vertebroplasty with EBRT will stabilize the spine, relieve the pain, prevent imminent VCFs and minimize or avoid the need for opioids. It is hypothesized that combining a spine stabilization procedure such as vertebroplasty with RT will be the most effective management for patients with spinal metastases than RT alone for patients with spinal metastases. Combined vertebroplasty and radiotherapy is not a standard treatment option at present. This study is designed to quantify the advantage of adding vertebroplasty to radiotherapy for patients with spinal metastases. If the study is proven to be significant, it could become the standard of care for patients with spinal metastases.

CONDITIONS

Official Title

Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants capable of giving informed consent or having an acceptable representative to consent on their behalf
  • Patients aged 18 years or older
  • Confirmed spinal vertebral metastases by CT, MRI, or bone scan
  • Painful vertebral spinal metastases in thoracic and/or lumbar spine with a Visual Analog Scale pain score of at least 2
  • Willingness and ability to comply with scheduled visits, treatment plans, tests, and study procedures
  • Life expectancy greater than 6 months, assessed clinically and by Linden model (group B or C)
  • ECOG performance status 0-2 or Karnofsky score of 60% or higher
  • No prior external beam radiotherapy to the target vertebral body or adjacent vertebrae
  • Women of childbearing potential must have a negative pregnancy test at screening and meet menopause criteria if applicable
  • Use of highly effective birth control methods during the study treatment period for patients of childbearing potential
  • Female participants must not breastfeed during study treatment
  • Male participants must agree not to donate sperm during study treatment
  • No conditions preventing compliance with study protocols and follow-up
Not Eligible

You will not qualify if you...

  • Unable to provide consent
  • Prior radiotherapy to the target vertebral body or adjacent levels
  • Life expectancy less than 6 months
  • Karnofsky performance status below 60%
  • Primary bone tumors
  • Plasmacytoma
  • Communicated fracture
  • Presence or risk of spinal cord compression
  • Epidural involvement

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions | DecenTrialz