Comparing SBRT to CRT in Patients With Spinal Metastases
COMBAT
Prospective Registry Trail COMparing Stereotactic Body Radiotherpy (SBRT) to Conventional PAlliative RadioTherapy (CRT) in Patients With Spinal Metastases
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedStudy Start
First participant enrolled
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 5, 2026
March 1, 2026
5 years
October 17, 2022
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Assess local progression free survival.
2 years
Measure pain response
2 years
Assess adverse events
2 years
Measure overall survival
2 years
Study Arms (2)
Stereotactic Radiotherapy (SBRT)
Standard of care stereotactic radiotherapy.
Conventional Radiotherapy (CRT)
Standard of care conventional radiotherapy.
Interventions
Standard of care radiotherapy administered as per institutional guidelines.
Eligibility Criteria
Patients who have MRI- or CT-documented spinal metastases and are suitable for receiving radiation therapy.
You may qualify if:
- 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
You may not qualify if:
- Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
- Lymphoma, myeloma or germ cell malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Health Network
Toronto, Ontario, M5G 1X6, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 21, 2022
Study Start
December 12, 2022
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03