Spinal MetastasesCOMBATNCT05589701
Comparing SBRT to CRT in Patients With Spinal Metastases
An observational study of Spinal Metastases, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2022to Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have MRI- or CT-documented spinal metastases and are suitable for receiving radiation therapy.
Who may be able to join
- 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
Who cannot join
- Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
- Lymphoma, myeloma or germ cell malignancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 1X6
David Shultz, MD., 416-946-4501 ext. 2121, david.shultz@rmp.uhn.ca
About this study
Official title: Prospective Registry Trail COMparing Stereotactic Body Radiotherpy (SBRT) to Conventional PAlliative RadioTherapy (CRT) in Patients With Spinal Metastases
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.
Read the 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.
- Conditions
- Spinal Metastases
- Being tested
- Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Standard of care radiotherapy administered as per institutional guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiotherapy (SBRT) | Standard of care stereotactic radiotherapy. Receives: Radiation: Radiotherapy | |
| Conventional Radiotherapy (CRT) | Standard of care conventional radiotherapy. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (4)
Assess local progression free survival.
Based on available imaging, compare local progression free survival outcomes of patients treated with SBRT vs CRT.
Measured: 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.
Measured: 2 years
Assess adverse events
Compare adverse events, collected through standard of care follow up, which occur for patients treated with SBRT vs CRT.
Measured: 2 years
Measure overall survival
Compare overall survival, collected through medical records, for patients treated with SBRT vs CRT.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start12 Dec 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589701
- Sponsor's protocol ID
- 22-5085
- Acronym
- COMBAT
- Status last verified
- Mar 2026
- First submitted
- 17 Oct 2022
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry Trail COMparing Stereotactic Body Radiotherpy (SBRT) to Conventional PAlliative RadioTherapy (CRT) in Patients With Spinal Metastases
- ClinicalTrials.gov ID
- NCT05589701
- Acronym / sponsor ID
- COMBAT / 22-5085
- Conditions
- Spinal Metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiotherapy (SBRT) | – | Radiation: RadiotherapyStandard of care stereotactic radiotherapy. |
| Conventional Radiotherapy (CRT) | – | Radiation: RadiotherapyStandard of care conventional radiotherapy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have MRI- or CT-documented spinal metastases and are suitable for receiving radiation therapy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
- Lymphoma, myeloma or germ cell malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyStandard of care radiotherapy administered as per institutional guidelines. | Radiation | Conventional Radiotherapy (CRT), Stereotactic Radiotherapy (SBRT) |
Primary outcome
Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation.
Time frame: 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).
4 secondary outcomes
Assess local progression free survival.
Time frame: 2 years
Measure pain response
Time frame: 2 years
Assess adverse events
Time frame: 2 years
Measure overall survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Metastases, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Shultz, MD (416-946-4501 ext. 2121, david.shultz@rmp.uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.