Recruiting
Phase 2

Definitive Radiation

Sponsor:

Stony Brook University

Code:

NCT06165419

Conditions

Metastatic Cancer

Metastatic Lung Cancer

Metastatic Breast Cancer

Metastatic Tumor

Metastatic Tumor of Bone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SBRT to the spine

Study Details

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

Conditions

Metastatic Cancer

Metastatic Lung Cancer

Metastatic Breast Cancer

Metastatic Tumor

Metastatic Tumor of Bone

Study ID

NCT06165419

Start date

Dec 14, 2023

Status verified date

Apr, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SBRT to the spine

Interventions

SBRT to the spine

Stereotactic body radiation therapy (SBRT) administered to spine metastases

Primary outcome measure

  • Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Hermina Munoz, RN

631-216-2990hermina.munoz@stonybrookmedicine.edu

Lucia Joya

631-216-2998lucia.joya@stonybrookmedicine.edu

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Caterina Vacchi-Suzzi, PhD

631-216-2993caterina.vacchi-suzzi@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

May 14, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2025-05-14.