COMBAT: Comparing SBRT to CRT in Patients With Spinal Metastases
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Stereotactic Radiotherapy (SBRT) Standard of care stereotactic radiotherapy. |
Radiation: Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
|
| Conventional Radiotherapy (CRT) Standard of care conventional radiotherapy. |
Radiation: Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
|
Outcome Measures
Primary Outcome Measures
- Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation. [2 years]
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).
Secondary Outcome Measures
- Assess local progression free survival. [2 years]
Based on available imaging, compare local progression free survival outcomes of patients treated with SBRT vs CRT.
- Measure pain response [2 years]
Using a patient reported scale (0 (no pain) to 10 (worst pain imaginable)), compare pain outcomes of patients treated with SBRT vs CRT.
- Assess adverse events [2 years]
Compare adverse events, collected through standard of care follow up, which occur for patients treated with SBRT vs CRT.
- Measure overall survival [2 years]
Compare overall survival, collected through medical records, for patients treated with SBRT vs CRT.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults 18 years of age or older.
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Patients seen at the Princess Margaret Cancer Centre with painful spinal metastases amenable to radiation treatment.
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Confirmation of diagnosis: a) Known/documented prior histological cancer diagnosis
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Able to provide written consent
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ECOG performance status 0-3
Exclusion Criteria:
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Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
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Lymphoma, myeloma or germ cell malignancies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Health Network | Toronto | Ontario | Canada | M5G 1X6 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-5085