About this trial
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.
Eligibility criteria
Qualifiers
Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
Patients must be 18 years of age or older
Spinal vertebral metastases confirmed by CT, MRI or bone scan.
Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and /or lumbar spine (not cervical).
Disqualifiers
Patient cannot provide consent
Prior radiotherapy to the target +/-1 vertebral body level
Life expectancy < 6 months (assessed both clinically and using Linden model)
Karnofsky performance status of < 60%
Trial design
Treatments tested in this trial
- Radiotherapy
- Vertebropladty
Treatment groups
Sponsors and collaborators
AHS Cancer Control Alberta
Lead sponsor
Cross Cancer Institute
Collaborator