BridgeMD
New treatment option for Spine Metastasis
Official title A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases
ClinicalTrials.gov ID: NCT07478289
What this study is testing
- What it's testing
- Spine SBRT is considered a standard of care for the treatment of spinal metastases. Compared to conventional radiation therapy, spine SBRT delivers high doses of radiation to the affected areas to the spinal metastases.
- 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
- Histopathologically confirmed solid tumor malignancy, or strong suspicion based on clinical and radiographic examination of malignancy
- Spinal metastases with paraspinal disease extension documented with MRI and recommended for treatment with SBRT
- Post-operative SBRT is permitted (after stabilization and/or decompression surgery) as long as no prior radiotherapy had been delivered to the spinal...
- ECOG performance status 0-2
- Able to tolerate protocol SBRT
You likely can't join if
- Extremely radiosensitive histology (seminoma, small cell lung cancer, hematologic primaries)
- Prior radiotherapy in the spine target of interest
- Spinal instability as assessed by the Spinal Instability Neoplastic Score with a score of \> 12
- Symptomatic cord compression or cauda equine syndrome resulting from bony compression or epidural compression of the spinal cord and cauda equina...
- Pacemaker, such that MRI cannot be performed or treatment cannot be delivered safely
- Cytotoxic chemotherapy within 1 week prior to radiotherapy delivery
See the full eligibility criteria
- Histopathologically confirmed solid tumor malignancy, or strong suspicion based on clinical and radiographic examination of malignancy
- Spinal metastases with paraspinal disease extension documented with MRI and recommended for treatment with SBRT
- Post-operative SBRT is permitted (after stabilization and/or decompression surgery) as long as no prior radiotherapy had been delivered to the spinal level planned for trial treatment and paraspinal disease is present
- ECOG performance status 0-2
- Able to tolerate protocol SBRT
- Age 18 years or older
- Patient is able and willing to complete the Patient Diary (pain and analgesic use)
- Consent must be appropriately obtained in accordance with local requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
- Patients must be accessible for treatment and follow-up
- Treatment to begin within 14 days (ideally 7 days) of radiotherapy simulation
- Extremely radiosensitive histology (seminoma, small cell lung cancer, hematologic primaries)
- Prior radiotherapy in the spine target of interest
- Spinal instability as assessed by the Spinal Instability Neoplastic Score with a score of \> 12
- Symptomatic cord compression or cauda equine syndrome resulting from bony compression or epidural compression of the spinal cord and cauda equina, respectively. Symptomatic refers to neurologic deficit in the form of...
- Pacemaker, such that MRI cannot be performed or treatment cannot be delivered safely
- Cytotoxic chemotherapy within 1 week prior to radiotherapy delivery
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, 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 Toronto, Ontario, 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.