Definitive Radiation for High-Risk Spine Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-14

Study Completion Date

2026-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT to the spine

Group Type EXPERIMENTAL

SBRT to the spine

Intervention Type RADIATION

Stereotactic body radiation therapy (SBRT) administered to spine metastases

Interventions

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SBRT to the spine

Stereotactic body radiation therapy (SBRT) administered to spine metastases

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No