Comparing SBRT to CRT in Patients With Spinal Metastases

Study Overview
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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.

Official Title
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Prospective Registry Trail COMparing Stereotactic Body Radiotherpy (SBRT) to Conventional PAlliative RadioTherapy (CRT) in Patients With Spinal Metastases

Conditions
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Spinal Metastases

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stereotactic Radiotherapy (SBRT)<br>Standard of care stereotactic radiotherapy. | Radiation: Radiotherapy<br>* Standard of care radiotherapy administered as per institutional guidelines.<br>|
| Conventional Radiotherapy (CRT)<br>Standard of care conventional radiotherapy. | Radiation: Radiotherapy<br>* Standard of care radiotherapy administered as per institutional guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation. | Physician's decision making will be assessed by a questionnaire containing 6 questions, including questions on variations of practice and the role of a number of factors that may influence a physician's recommendation for spine metastasis patients requiring radiation (SBRT vs CRT). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess local progression free survival. | Based on available imaging, compare local progression free survival outcomes of patients treated with SBRT vs CRT. | 2 years | 
| Measure pain response | Using a patient reported scale (0 (no pain) to 10 (worst pain imaginable)), compare pain outcomes of patients treated with SBRT vs CRT. | 2 years | 
| Assess adverse events | Compare adverse events, collected through standard of care follow up, which occur for patients treated with SBRT vs CRT. | 2 years | 
| Measure overall survival | Compare overall survival, collected through medical records, for patients treated with SBRT vs CRT. | 2 years |