Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Les… (NCT04242589) | Clinical Trial Compass
RecruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Canada64 participantsStarted 2021-03-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Patients must be willing and able to comply with schedule visits, treatment plan, tests and other study procedures
✓. Life expectancy \> 6 months. Life expectancy will be evaluated by the study investigator both clinically and by using Linden model. Patient should be in the group B or C of the Linden model.
✓. Patients with an ECOG score 0-2 or Karnofsky performance status of ≥ 60% will be eligible for enrolment (see appendix 1).
✓. No prior EBRT to the target +/-1 vertebral body level
Exclusion criteria
What they're measuring
1
Improvement in Pain Score based on the Visual Analog Scale
Timeframe: 1,3,6 and 12 months post treatment
2
Improvement in Pain Score based on the Brief Pain Inventory