Definitive Radiation for High-Risk Spine Metastases

Phase 2

Recruiting

• Conditions: Metastatic Tumor; Metastatic Breast Cancer; Spine Metastases; Metastatic Cancer; Metastatic Lung Cancer; Metastatic Tumor to the Spine; Metastatic Tumor of Bone; Metastasis
• Interventions: Radiation: SBRT to the spine

• Registration Number: NCT06165419
• Lead Sponsor: Stony Brook University

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 available

Study Timeline

• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-11
• Study Start: 2023-12-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT to the spine	SBRT to the spine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire	1 months, 3 months, 6 months	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)
Changes on Oswestry Low Back Disability Questionnaire	1 months, 3 months, 6 months	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.
Reduction in epidural tumor volume	3 months	Percent reduction of epidural volume of the treated metastatic lesions
Changes on Neck Disability index	1 months, 3 months, 6 months	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.
Progression-free survival	6 months
Overall survival	6 months

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States