SBRT in the Management of Solid Spinal 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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-18

Study Completion Date

2036-03-01

Brief Summary

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Documenting efficiency of SBRT in the management of epidural spinal metastases from solid tumors

Detailed Description

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The department of radiotherapy in UZLeuven recently included Stereotactic Body Radiotherapy (SBRT) in the standard of care for the management of patients with spinal metastases. The aim of this study is to prospectively document neurological outcome, performance and quality of life following surgery + SBRT for spinal metastases with imminent / actual spinal cord compression, and compare outcomes with the historical cohort of the UZLeuven patients included in the Global Spine Tumor Study Group database between 2011 and 2019 in whom prospective neurological, performance and quality of life outcomes were collected following surgery + conventional radiotherapy

Conditions

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Extradural Tumor Spinal Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Radiological diagnosis of spinal metastasis from solid tumor with epidural imminent or actual spinal cord compression, with or without neurological deficits. Patients will be scheduled for surgery + SBRT. If contra-indications preclude surgery and only SBRT is performed, patients will still be included.
* Written informed consent to participate in the study must be obtained from the subject or proxy /legal representative
* Males and females \> 18 years

Exclusion Criteria

* Any concomitant condition or disease which, in the opinion of the investigator, would affect the reliability of the collected data.
* Patients that had previous radiotherapy on the index spinal level without the possibility for additional SBRT at that particular level.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bart Depreitere, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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University hospital Leuven

Leuven, Vlaams Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Bart Depreitere, Phd, MD

Role: CONTACT

Phone: +3216344290

Email: [email protected]

Facility Contacts

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Bart Depreitere, Phd MD

Role: primary

Other Identifiers

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Extradural Tumors

Identifier Type: -

Identifier Source: org_study_id