Definitive Radiation for High-Risk Spine Metastases

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

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Metastatic Lung Cancer; Metastatic Breast Cancer; Metastasis; Spine Metastases; Metastatic Tumor; Metastatic Tumor of Bone; Metastatic Tumor to the Spine
• Intervention / Treatment: Radiation: SBRT to the spine

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hermina Munoz, RN; Phone Number: 631-216-2990; Email: hermina.munoz@stonybrookmedicine.edu
• Study Contact Backup: Name: Lucia Joya; Phone Number: 631-216-2998; Email: lucia.joya@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Contact: Caterina Vacchi-Suzzi, PhD; Phone Number: 631-216-2993; Email: caterina.vacchi-suzzi@stonybrookmedicine.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT to the spine	Radiation: SBRT to the spine; Stereotactic body radiation therapy (SBRT) administered to spine metastases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival		6 months
Overall survival		6 months
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.	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.	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)	1 months, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Kartik Mani, MD PhD, Stony Brook Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: SBU-RT-MESCC; IRB2023-00421 (Other Identifier: Stony Brook University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No