Definitive Radiation for High-Risk Spine Metastases

NCT06165419 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: SBU-RT-MESCCIRB2023-00421
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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; Metastatic Tumor to the Spine; Spine Metastases; Metastasis

Outcome Measures

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

  6 months

Secondary Outcomes (6)

• Reduction in epidural tumor volume

  3 months

• Changes on Neck Disability index

  1 months, 3 months, 6 months

• Changes on Oswestry Low Back Disability Questionnaire

  1 months, 3 months, 6 months

• Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire

  1 months, 3 months, 6 months

• Progression-free survival

  6 months

Study Arms (1)

SBRT to the spine

EXPERIMENTAL

Radiation: SBRT to the spine

Interventions

SBRT to the spine RADIATION

Stereotactic body radiation therapy (SBRT) administered to spine metastases

SBRT to the spine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stony Brook University: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Lung Neoplasms; Breast Neoplasms; Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kartik Mani, MD PhD

  Stony Brook Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermina Munoz, RN

CONTACT

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

Lucia Joya

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)