Definitive Radiation for High-Risk Spine Metastases | NCT06165419

Studies
Definitive Radiation for High-Risk Spine Metastases

NCT06165419

Sponsor

Stony Brook University

Status

Recruiting

Last Update Posted

May 14, 2025Actual

Enrollment

26Estimated

Phase

Phase 2

Conditions

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

Interventions

SBRT to the spine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB2023-00421	Other Identifier	Stony Brook University

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2023Actual

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2026Estimated

First Submitted Date

Dec 1, 2023

First Submission Date that Met QC Criteria

Dec 1, 2023

First Posted Date

Dec 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2025

Last Update Posted Date

May 14, 2025Actual

Name	Class
The University of Texas Health Science Center at San Antonio	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SBRT to the spine	Experimental		Radiation: SBRT to the spine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SBRT to the spine	Radiation	Stereotactic body radiation therapy (SBRT) administered to spine metastases	SBRT to the spine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT	Assess the efficacy of spine SBRT alone in controlling spine metastases	6 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction in epidural tumor volume	Percent reduction of epidural volume of the treated metastatic lesions	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hermina Munoz, RN	Contact	631-216-2990		hermina.munoz@stonybrookmedicine.edu
Lucia Joya	Contact	631-216-2998		lucia.joya@stonybrookmedicine.edu

Overall Officials

Name	Affiliation	Role
Kartik Mani, MD PhD	Stony Brook Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stony Brook University Hospital	Recruiting	Stony Brook	New York	11794	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009362	Neoplasm Metastasis
D008175	Lung Neoplasms
D001943	Breast Neoplasms
D001859	Bone Neoplasms

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided