Comparing SBRT to CRT in Patients With Spinal Metastases

Recruiting

• Conditions: Spinal Metastases
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT05589701
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-21
• Study Start: 2022-12-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
• Lymphoma, myeloma or germ cell malignancies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stereotactic Radiotherapy (SBRT)	Radiotherapy	Standard of care stereotactic radiotherapy.
Conventional Radiotherapy (CRT)	Radiotherapy	Standard of care conventional radiotherapy.

Primary Outcome Measures

Name	Time	Method
Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation.	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).

Secondary Outcome Measures

Name	Time	Method
Measure overall survival	2 years	Compare overall survival, collected through medical records, for patients treated with SBRT vs CRT.
Assess local progression free survival.	2 years	Based on available imaging, compare local progression free survival outcomes of patients treated with SBRT vs CRT.
Measure pain response	2 years	Using a patient reported scale (0 (no pain) to 10 (worst pain imaginable)), compare pain outcomes of patients treated with SBRT vs CRT.
Assess adverse events	2 years	Compare adverse events, collected through standard of care follow up, which occur for patients treated with SBRT vs CRT.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada