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Comparing SBRT to CRT in Patients With Spinal Metastases

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05589701
Acronym
COMBAT
Enrollment
100
Registered
2022-10-21
Start date
2022-12-12
Completion date
2027-12-01
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Metastases

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.

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.

Interventions

RADIATIONRadiotherapy

Standard of care radiotherapy administered as per institutional guidelines.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation.2 yearsPhysician'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

MeasureTime frameDescription
Assess local progression free survival.2 yearsBased on available imaging, compare local progression free survival outcomes of patients treated with SBRT vs CRT.
Measure pain response2 yearsUsing a patient reported scale (0 (no pain) to 10 (worst pain imaginable)), compare pain outcomes of patients treated with SBRT vs CRT.
Assess adverse events2 yearsCompare adverse events, collected through standard of care follow up, which occur for patients treated with SBRT vs CRT.
Measure overall survival2 yearsCompare overall survival, collected through medical records, for patients treated with SBRT vs CRT.

Countries

Canada

Contacts

CONTACTDavid Shultz, MD
david.shultz@rmp.uhn.ca416-946-4501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026