BridgeMD
New treatment option for Spinal Metastases
Official title Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
ClinicalTrials.gov ID: NCT04242589
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the...
- 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
You likely can't join if
- 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%
- Primary bone tumors
- Plasmacytoma
See the full eligibility 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
- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical...
- Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is...
- Females must not breastfeed during study treatment.
- Male patients should agree to not donate sperm during study treatment.
- Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration
- 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%
- Primary bone tumors
- Plasmacytoma
- Communicated fracture
- Associated Impending cord compression or spinal cord compression
- Epidural involvement
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.