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A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases

OPTimized Dose Escalation With Simultaneous Integrated Boost for High Risk Spinal Metastases: a Prospective Phase II TriAL (OPTIMAL)

NCT07478289•Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Key Dates

Start Date

April 1, 2026

Primary Completion Date

December 1, 2029

Completion Date

December 1, 2031

Last Updated

March 17, 2026

Enrollment

108

ESTIMATED participants

Conditions

Spine Metastasis

Interventions

Radiation Boost

RADIATION

A Study to Quantify Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)

NCT03072979

Spine Metastasis

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UNKNOWNPHASE2

Diffusion-Weighted Magnetic Resonance Imaging

NCT02242786

Hepatocellular CarcinomaSpine Metastasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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