Recruiting
Phase 2

Spine SBRT

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07478289

Conditions

Spine Metastasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation Boost

Study Details

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.

Conditions

Spine Metastasis

Study ID

NCT07478289

Start date

Apr, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

108 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiation Boost

Participants would receive a radiation boost to their spinal metastases (as described in "Intervention")

Interventions

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).

Primary outcome measure

  • Disease Progression within the Treated Spinal Metastasis, in accordance with SPINO (SPIne assessment in Neuro-Oncology) guidelines [ Time Frame: Up to 12 months after completion of radiation therapy ]

Central Contacts and Locations

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Aimee Theriault

4164805000Aimee.Theriault@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • spinal metastases
  • SBRT
  • Simultaneous Integrated Boost

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-03-17.