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Clinical Trials in Canada / NCT07478289
Recruiting Phase 2

A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases

NCT07478289 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2026-04
Last updated
2026-03-17

Condition(s) studied

Spine Metastasis

Investigational drug(s) / intervention(s)

Radiation Boost

Radiation Boost: An additional boost of radiation will be delivered to the spinal metastases. The amount of boost depends on how much radiation would have been normally prescribed (e.g., if treatment required 2 fractions of radiation treatment, an additional 2 Gy would be prescribed; if treatment required 4 fractions of radiation treatment, an additional 4 Gy would be prescribed; if treatment required 5 fractions of radiation treatment, an additional 5 Gy would be prescribed).

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sunnybrook Health Sciences Centre Toronto Ontario Recruiting

More Sunnybrook Health Sciences Centre trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07478289 on ClinicalTrials.gov ↗ ← All trials in Canada