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Recruiting NCT06165419

Definitive Radiation for High-Risk Spine Metastases

Phase II Interventional Metastatic Cancer Metastatic Lung Cancer Metastatic Breast Cancer Metastatic Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SBRT to the spine.
Who it may be relevant to
Registry conditions: Metastatic Cancer, Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT [Time frame: 6 months]
Secondary outcome measures (6)
  • Reduction in epidural tumor volume [Time frame: 3 months]
  • Changes on Neck Disability index [Time frame: 1 months, 3 months, 6 months]
  • Changes on Oswestry Low Back Disability Questionnaire [Time frame: 1 months, 3 months, 6 months]
  • Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire [Time frame: 1 months, 3 months, 6 months]
  • Progression-free survival [Time frame: 6 months]
  • Overall survival [Time frame: 6 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stony Brook University Hospital — Stony Brook

Identifiers

NCT: NCT06165419 · SBU-RT-MESCC · IRB2023-00421

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗