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Clinical Trial NCT07478289 (OPTIMAL) for Spine Metastasis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases (OPTIMAL) Phase 2 108

Recruiting
Clinical Trial NCT07478289 (OPTIMAL) is designed to study Treatment for Spine Metastasis. It is a Phase 2 interventional study that is recruiting, having started on April 1, 2026, with plans to enroll 108 participants. Led by Sunnybrook Health Sciences Centre, it is expected to complete by December 1, 2031. The latest data from ClinicalTrials.gov was last updated on March 17, 2026.
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...

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Official Title

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

Conditions
Spine Metastasis
Other Study IDs
  • OPTIMAL
NCT ID Number
NCT07478289
Start Date (Actual)
2026-04
Last Update Posted
2026-03-17
Completion Date (Estimated)
2031-12
Enrollment (Estimated)
108
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
spinal metastases
SBRT
Simultaneous Integrated Boost
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalRadiation Boost
Participants would receive a radiation boost to their spinal metastases (as described in "Intervention")
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 treatme...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Whether the progression occurred at local, marginal, or distant location
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Sunnybrook Health Sciences Centre logoSunnybrook Health Sciences Centre
No contact data.
1 Study Locations in 1 Countries

Ontario

Sunnybrook Health Sciences Centre, Toronto, Ontario, M4N3M5, Canada
Aimee Theriault, Contact, 4164805000, [email protected]
Recruiting