Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07478289

A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases

Led by Sunnybrook Health Sciences Centre · Updated on 2026-03-17

108

Participants Needed

1

Research Sites

295 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathologically confirmed solid tumor malignancy, or strong suspicion based on clinical and radiographic examination of malignancy
  • Spinal metastases with paraspinal disease extension documented by MRI and recommended for SBRT treatment
  • Post-operative SBRT permitted if no prior radiotherapy was given to the spinal level planned for treatment and paraspinal disease is present
  • ECOG performance status between 0 and 2
  • Able to tolerate protocol SBRT
  • Age 18 years or older
  • Able and willing to complete the Patient Diary for pain and analgesic use
  • Consent obtained according to local requirements with signed consent form
  • Accessible for treatment and follow-up
  • Treatment to begin within 14 days (ideally 7 days) after radiotherapy simulation
Not Eligible

You will not qualify if you...

  • Extremely radiosensitive cancers such as seminoma, small cell lung cancer, and hematologic primaries
  • Prior radiotherapy to the spine target area
  • Spinal instability with Spinal Instability Neoplastic Score greater than 12
  • Symptomatic cord compression or cauda equina syndrome causing motor, bowel, or bladder dysfunction
  • Presence of pacemaker preventing safe MRI or treatment delivery
  • Cytotoxic chemotherapy within 1 week before radiotherapy delivery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N3M5

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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