NCT07478289 A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases
| NCT ID | NCT07478289 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Spine Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2026-04 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 108 participants in total. It began in 2026-04 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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 motor, bowel or bladder dysfunction * Pacemaker, such that MRI cannot be performed or treatment cannot be delivered safely * Cytotoxic chemotherapy within 1 week prior to radiotherapy delivery
Frequently Asked Questions
Who can join the NCT07478289 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spine Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07478289 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07478289 currently recruiting?
Yes, NCT07478289 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sunnybrook Health Sciences Centre to inquire about joining.
Where is the NCT07478289 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07478289 clinical trial?
NCT07478289 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 108 participants.