Comparing SBRT to CRT in Patients With Spinal Metastases

Spinal Metastases Clinical Trial

— COMBAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05589701
• Other study ID #: 22-5085
• Status: Recruiting
• Start date: December 12, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: David Shultz, MD
• Phone: 416-946-4501
• Email: david.shultz[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Intervention

Radiation:
• Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assess local progression free survival.	Based on available imaging, compare local progression free survival outcomes of patients treated with SBRT vs CRT.	2 years
Secondary	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
Secondary	Assess adverse events	Compare adverse events, collected through standard of care follow up, which occur for patients treated with SBRT vs CRT.	2 years
Secondary	Measure overall survival	Compare overall survival, collected through medical records, for patients treated with SBRT vs CRT.	2 years