A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases

NCT07478289 | Recruiting Phase 2

• 1 other identifier: OPTIMAL
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

spinal metastases; SBRT; Simultaneous Integrated Boost

Outcome Measures

Primary Outcomes (1)

• Disease Progression within the Treated Spinal Metastasis, in accordance with SPINO (SPIne assessment in Neuro-Oncology) guidelines

  Up to 12 months after completion of radiation therapy

Secondary Outcomes (4)

• Pain at treated spinal metastases, per ICPRE (International Consensus on Palliative Radiotherapy Endpoints)

  3 and 6 months following completion of radiation therapy

• Type of progression

  Up to 12 months after completion of radiation therapy

• Treatment-related side effects as assessed by CTCAE v5.0

  Up to 12 months following completion of radiation therapy

• Spinal Instability, as assessed through the Spinal Instability Neoplastic Scores (SINS)

  Up to 12 months following completion of radiation therapy

Study Arms (1)

Radiation Boost

EXPERIMENTAL

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

Radiation: Radiation Boost

Interventions

Radiation Boost RADIATION

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).

Radiation Boost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)