Metastatic CancerPhase 2NCT06165419
Definitive Radiation for High-Risk Spine Metastases
A Phase 2 study testing SBRT to the spine in people with Metastatic Cancer and Metastatic Lung Cancer, run by Stony Brook University at 1 site in United States.
Trial summary
This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Metastatic Lung Cancer, Metastatic Breast Cancer
- What is being tested?
- SBRT to the spine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2023to 31 May 2026
- 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
Eligible patients must have:
- Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease
- Metastatic spine involvement documented by imaging
- Involvement of maximum 3 contiguous vertebral bodies at the index site
- Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids
- An evaluation by an radiation oncology and orthopedic spine/neurosurgery attending
- ECOG Performance Status of 0-3
Patients are ineligible if they have:
- An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12
- Had previous surgery or radiation to address the target spinal metastases
- Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Caterina Vacchi-Suzzi, PhD, 631-216-2993, caterina.vacchi-suzzi@stonybrookmedicine.edu
About this study
Official title: A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases
This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery
- Conditions
- Metastatic Cancer, Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Tumor, Metastatic Tumor of Bone, Metastatic Tumor to the Spine
- Being tested
- SBRT to the spine
- Medical subject headings
- Neoplasm Metastasis, Lung Neoplasms, Breast Neoplasms, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT to the spineRadiation
Stereotactic body radiation therapy (SBRT) administered to spine metastases
| Study group | Role | What they receive |
|---|---|---|
| SBRT to the spine | Experimental | Not described Receives: Radiation: SBRT to the spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT
Assess the efficacy of spine SBRT alone in controlling spine metastases
Measured: 6 months
Secondary outcomes (6)
Reduction in epidural tumor volume
Percent reduction of epidural volume of the treated metastatic lesions
Measured: 3 months
Changes on Neck Disability index
The Neck Disability Index measures neck pain and disabilities in patients with neck pain, with scores varying from 0 to 50. Lower scores indicate better outcomes, higher scores indicate a worse outcome.
Measured: 1 months, 3 months, 6 months
Changes on Oswestry Low Back Disability Questionnaire
The Oswestry Disability Index measures disability in patients with low back pain, with scores varying from 0 to 50. Lower scores indicate better outcomes, higher scores indicate a worse outcome.
Measured: 1 months, 3 months, 6 months
Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire
The EuroQol 5D-5L questionnaire measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each health dimension is scored from 1 to 5, with 1 indicating a better health state, and 5 the worse state possible. Respondents also indicate their overall health status on visual analogue score, with values ranging from 0 (worst health imaginable) to 100 (best health imaginable)
Measured: 1 months, 3 months, 6 months
Progression-free survival
Measured: 6 months
Overall survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start14 Dec 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kartik Mani, Stony Brook University
- Investigators
- Kartik Mani, MD PhD, Principal investigator, Stony Brook Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165419
- Sponsor's protocol ID
- SBU-RT-MESCC
- Other IDs
- IRB2023-00421
- Status last verified
- Apr 2025
- First submitted
- 1 Dec 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases
- ClinicalTrials.gov ID
- NCT06165419
- Acronym / sponsor ID
- SBU-RT-MESCC
- Conditions
- Metastatic Cancer, Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Tumor, Metastatic Tumor of Bone, Metastatic Tumor to the Spine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 11 Dec 2023 (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.
This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT to the spine | Experimental | Radiation: SBRT to the spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SBRT to the spineStereotactic body radiation therapy (SBRT) administered to spine metastases | Radiation | SBRT to the spine |
Primary outcome
Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT
Time frame: 6 months
Assess the efficacy of spine SBRT alone in controlling spine metastases
6 secondary outcomes
Reduction in epidural tumor volume
Time frame: 3 months
Changes on Neck Disability index
Time frame: 1 months, 3 months, 6 months
Changes on Oswestry Low Back Disability Questionnaire
Time frame: 1 months, 3 months, 6 months
Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire
Time frame: 1 months, 3 months, 6 months
Progression-free survival
Time frame: 6 months
Overall survival
Time frame: 6 months
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 14 May 2025.
- Individual participant dataSharing planned: No
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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.
Kartik Mani, MD PhD principal investigator
Stony Brook Cancer Center
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 SBRT to the spine in people with Metastatic Cancer and Metastatic Lung Cancer, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 May 2025. 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 United States. 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?
Contact Hermina Munoz, RN (631-216-2990, hermina.munoz@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT (time frame: 6 months). 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 14 May 2025.