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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Metastases
• Intervention / Treatment: Radiation: Radiotherapy

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: David Shultz, MD; Phone Number: 2121 416-946-4501; Email: david.shultz@rmp.uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X6
      • Recruiting
      • University Health Network
      • Contact: David Shultz, MD.; Phone Number: 2121 416-946-4501; Email: david.shultz@rmp.uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have MRI- or CT-documented spinal metastases and are suitable for receiving radiation therapy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Therapeutics; Radiotherapy
• Other Study ID Numbers: 22-5085

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No