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Trial Title:
Comparing SBRT to CRT in Patients With Spinal Metastases
NCT ID:
NCT05589701
Condition:
Spinal Metastases
Conditions: Official terms:
Neoplasm Metastasis
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Standard of care radiotherapy administered as per institutional guidelines.
Arm group label:
Conventional Radiotherapy (CRT)
Arm group label:
Stereotactic Radiotherapy (SBRT)
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.
Criteria for eligibility:
Study pop:
Patients who have MRI- or CT-documented spinal metastases and are suitable for receiving
radiation therapy.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Health Network
Address:
City:
Toronto
Zip:
M5G 1X6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
David Shultz, MD.
Phone:
416-946-4501
Phone ext:
2121
Email:
david.shultz@rmp.uhn.ca
Start date:
December 12, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05589701
