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Recruiting NCT05589701

Comparing SBRT to CRT in Patients With Spinal Metastases

Observational Spinal Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy.
Who it may be relevant to
Registry conditions: Spinal Metastases. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation. [Time frame: 2 years]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • University Health Network — Toronto

Identifiers

NCT: NCT05589701 · 22-5085

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗