Actively Recruiting
A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases
Led by Sunnybrook Health Sciences Centre · Updated on 2026-03-17
108
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. This study is interested in seeing whether an additional 'boost' of radiation, delivered to the affected area in the spine, will result in better long-term control of the tumor; help reduce pain; and reduce long-term side effects of radiation therapy.
CONDITIONS
Official Title
A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed solid tumor malignancy, or strong suspicion based on clinical and radiographic examination of malignancy
- Spinal metastases with paraspinal disease extension documented by MRI and recommended for SBRT treatment
- Post-operative SBRT permitted if no prior radiotherapy was given to the spinal level planned for treatment and paraspinal disease is present
- ECOG performance status between 0 and 2
- Able to tolerate protocol SBRT
- Age 18 years or older
- Able and willing to complete the Patient Diary for pain and analgesic use
- Consent obtained according to local requirements with signed consent form
- Accessible for treatment and follow-up
- Treatment to begin within 14 days (ideally 7 days) after radiotherapy simulation
You will not qualify if you...
- Extremely radiosensitive cancers such as seminoma, small cell lung cancer, and hematologic primaries
- Prior radiotherapy to the spine target area
- Spinal instability with Spinal Instability Neoplastic Score greater than 12
- Symptomatic cord compression or cauda equina syndrome causing motor, bowel, or bladder dysfunction
- Presence of pacemaker preventing safe MRI or treatment delivery
- Cytotoxic chemotherapy within 1 week before radiotherapy delivery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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