Radiation boost for painful spinal metastases
OPTimized Dose Escalation With Simultaneous Integrated Boost for High Risk Spinal Metastases: a Prospective Phase II TriAL (OPTIMAL)
This study will try adding an extra focused radiation boost to standard spine SBRT for adults with painful spinal metastases to see if it improves long-term tumor control and reduces pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07478289 on ClinicalTrials.gov |
What this trial studies
This Phase II, single-center protocol delivers an additional targeted radiation "boost" to paraspinal disease in patients receiving spine SBRT for metastatic solid tumors. Eligible adults (ECOG 0–2) with MRI-documented paraspinal extension, including post-operative patients with no prior radiation to the treated level, will receive the boosted SBRT and complete a pain and analgesic-use diary. Treatment is to begin within 14 days of simulation and follow-up will record local tumor control, pain scores, and late radiation-related side effects. The trial is conducted at Sunnybrook Health Sciences Centre in Toronto.
Who should consider this trial
Good fit: Adults (≥18 years) with solid-tumor spinal metastases showing paraspinal extension, ECOG performance status 0–2, who can tolerate SBRT and complete the pain/analgesic diary are ideal candidates.
Not a fit: Patients who previously received radiotherapy to the same spinal level, those with ECOG >2, or those unable to tolerate SBRT are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the boost could improve long-term control of spinal tumors and reduce chronic pain for affected patients.
How similar studies have performed: High-dose spine SBRT has shown good local control and pain relief in prior studies, but adding a dedicated paraspinal boost is less well studied and remains investigational.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.