Radiation boost for painful spinal metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.