ClinicalTrials.gg
RecruitingNCT06165419Updated May 14, 2025

Definitive Radiation for High-Risk Spine Metastases

A Phase 2 interventional study of SBRT to the spine in Metastatic Cancer, Metastatic Lung Cancer and Metastatic Breast Cancer, sponsored by Stony Brook University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Stony Brook University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Metastatic Cancer
  • Metastatic Lung Cancer
  • Metastatic Breast Cancer
  • Metastatic Tumor
  • Metastatic Tumor of Bone
  • Metastatic Tumor to the Spine
  • Spine Metastases
  • Metastasis
03

In context

Neoplasm Metastasis

4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.

This study's planned enrollment of 26 is below the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Stony Brook University is the lead sponsor of 197 studies on the registry; 36 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 11 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Eligible patients must have:

  • Any proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of 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
  • An evaluation by an radiation oncology and orthopedic spine/neurosurgery attending
  • 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)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    SBRT to the spine

    Radiation: SBRT to the spine

Interventions

  • RadiationSBRT to the spine

    Stereotactic body radiation therapy (SBRT) administered to spine metastases

06

What researchers measure

Primary outcomes

  1. Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT

    Assess the efficacy of spine SBRT alone in controlling spine metastases

    Time frame: 6 months

Secondary outcomes

  1. Reduction in epidural tumor volume

    Percent reduction of epidural volume of the treated metastatic lesions

    Time frame: 3 months

  2. 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.

    Time frame: 1 months, 3 months, 6 months

  3. 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.

    Time frame: 1 months, 3 months, 6 months

  4. 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)

    Time frame: 1 months, 3 months, 6 months

  5. Progression-free survival

    Time frame: 6 months

  6. Overall survival

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2023 (actual). Primary completion is estimated for May 2026, 29 months after the start.

Of 354 non-industry phase 2 interventional studies under Neoplasm Metastasis, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 90. This study's planned 29 months is below that.

Counting every sponsor, half of 442 studies reached it within 55 months; a quarter within 33 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2023
First posted
Dec 11, 2023
StartActual
Dec 14, 2023
Primary completionEst.
May 31, 2026
CompletionEst.
May 31, 2026
Last update
May 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06165419
Responsible party
Kartik Mani (Assistant Professor of Medicine, Stony Brook University) — Principal investigator
First posted
Dec 11, 2023
Start date
Dec 14, 2023
Primary completion
May 31, 2026 (estimated)
Completion
May 31, 2026 (estimated)
Last update
May 14, 2025

Study contacts

Hermina Munoz, RN
Contact
hermina.munoz@stonybrookmedicine.edu
631-216-2990
Lucia Joya
Contact
lucia.joya@stonybrookmedicine.edu
631-216-2998
Kartik Mani, MD PhD
principal investigator · Stony Brook Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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