Comparing SBRT to CRT in Patients With Spinal Metastases

NCT ID: NCT05589701

Last Updated: 2025-02-10

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

2022-12-12

Study Completion Date

2027-12-31

Brief Summary

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This is a single institutional registry-based, prospective, observational study to describe radiation oncologists' decision making during evaluation of patients and to compare real-world outcomes of SBRT vs CRT.

A registry-based trial involves observing the effect of something without manipulating it.

Detailed Description

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The purpose of this study is to study the differences between CRT and SBRT. The investigator's are assessing radiation oncologists' decision-making during the evaluation of patients with spinal metastases by requesting radiation oncologists complete a questionnaire. Additionally, the investigator's will compare outcomes, including local progression, pain response and overall survival between SBRT and CRT. By collecting this information, the investigator's will develop an evidence-based algorithm that may be used to support medical decision-making for others with spinal metastases in the future.

Conditions

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Spinal Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stereotactic Radiotherapy (SBRT)

Standard of care stereotactic radiotherapy.

Radiotherapy

Intervention Type RADIATION

Standard of care radiotherapy administered as per institutional guidelines.

Conventional Radiotherapy (CRT)

Standard of care conventional radiotherapy.

Radiotherapy

Intervention Type RADIATION

Standard of care radiotherapy administered as per institutional guidelines.

Interventions

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Radiotherapy

Standard of care radiotherapy administered as per institutional guidelines.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Adults 18 years of age or older.
* Patients seen at the Princess Margaret Cancer Centre with painful spinal metastases amenable to radiation treatment.
* Confirmation of diagnosis: a) Known/documented prior histological cancer diagnosis
* Able to provide written consent
* ECOG performance status 0-3

Exclusion Criteria

* Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
* Lymphoma, myeloma or germ cell malignancies
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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David Shultz, MD

Role: CONTACT

416-946-4501 ext. 2121

Facility Contacts

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David Shultz, MD.

Role: primary

416-946-4501 ext. 2121

Other Identifiers

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22-5085

Identifier Type: -

Identifier Source: org_study_id

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