A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases

Stony Brook University1 site in 1 country26 target enrollmentDecember 14, 2023

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

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Metastatic Cancer
Sponsor: Stony Brook University
Enrollment: 26
Locations: 1
Primary Endpoint: Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 14, 2023

End Date

May 31, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stony Brook University

Responsible Party

Principal Investigator

Kartik Mani

Assistant Professor of Medicine

Stony Brook University

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Time Frame: 6 months

Assess the efficacy of spine SBRT alone in controlling spine metastases

Secondary Outcomes

Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire(1 months, 3 months, 6 months)
Changes on Oswestry Low Back Disability Questionnaire(1 months, 3 months, 6 months)
Changes on Neck Disability index(1 months, 3 months, 6 months)
Progression-free survival(6 months)
Reduction in epidural tumor volume(3 months)
Overall survival(6 months)