Definitive Radiation for High-Risk Spine Metastases

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06165419
• Other study ID #: SBU-RT-MESCC
• Secondary ID: IRB2023-00421
• Status: Recruiting
• Phase: Phase 2
• Start date: December 14, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: January 2024
• Source: Stony Brook University
• Contact: Hermina Munoz, RN
• Phone: 631-216-2990
• Email: hermina.munoz[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Neoplasms
• Metastasis
• Metastatic Breast Cancer
• Metastatic Cancer
• Metastatic Lung Cancer
• Metastatic Tumor
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Spine Metastases

Intervention

Radiation:
• SBRT to the spine
Stereotactic body radiation therapy (SBRT) administered to spine metastases

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction in epidural tumor volume	Percent reduction of epidural volume of the treated metastatic lesions	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Progression-free survival		6 months
Secondary	Overall survival		6 months