Spine MetastasisPhase 2OPTIMALNCT07478289
A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases
A Phase 2 study testing Radiation Boost in people with Spine Metastasis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Metastasis
- What is being tested?
- Radiation Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2026to Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Aimee Theriault, 4164805000, Aimee.Theriault@sunnybrook.ca
About this study
Official title: OPTimized Dose Escalation With Simultaneous Integrated Boost for High Risk Spinal Metastases: a Prospective Phase II TriAL (OPTIMAL)
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
- Being tested
- Radiation Boost
- Keywords
- spinal metastases, SBRT, Simultaneous Integrated Boost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation BoostRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| Radiation Boost | Experimental | Participants would receive a radiation boost to their spinal metastases (as described in "Intervention") Receives: Radiation: Radiation Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Progression within the Treated Spinal Metastasis, in accordance with SPINO (SPIne assessment in Neuro-Oncology) guidelines
Measured: 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)
Measured: 3 and 6 months following completion of radiation therapy
Type of progression
Whether the progression occurred at local, marginal, or distant location
Measured: Up to 12 months after completion of radiation therapy
Treatment-related side effects as assessed by CTCAE v5.0
Measured: Up to 12 months following completion of radiation therapy
Spinal Instability, as assessed through the Spinal Instability Neoplastic Scores (SINS)
Measured: Up to 12 months following completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine MetastasisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478289
- Sponsor's protocol ID
- OPTIMAL
- Acronym
- OPTIMAL
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTimized Dose Escalation With Simultaneous Integrated Boost for High Risk Spinal Metastases: a Prospective Phase II TriAL (OPTIMAL)
- ClinicalTrials.gov ID
- NCT07478289
- Acronym / sponsor ID
- OPTIMAL / OPTIMAL
- Conditions
- Spine Metastasis
- Keywords
- spinal metastases, SBRT, Simultaneous Integrated Boost
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Boost | Experimental | Radiation: Radiation BoostParticipants would receive a radiation boost to their spinal metastases (as described in "Intervention") |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation BoostAn 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 | Radiation Boost |
Primary outcome
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
4 secondary outcomes
Pain at treated spinal metastases, per ICPRE (International Consensus on Palliative Radiotherapy Endpoints)
Time frame: 3 and 6 months following completion of radiation therapy
Type of progression
Time frame: Up to 12 months after completion of radiation therapy
Treatment-related side effects as assessed by CTCAE v5.0
Time frame: Up to 12 months following completion of radiation therapy
Spinal Instability, as assessed through the Spinal Instability Neoplastic Scores (SINS)
Time frame: Up to 12 months following completion of radiation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Spine Metastasis
Active, not recruitingPhase 1
Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery
Metastatic Spine Lesions
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
Recruiting
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Active, not recruitingPhase 2
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
Spinal Metastases
RecruitingPhase 3
Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases
Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation Boost in people with Spine Metastasis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.