Comparing SBRT to CRT in Patients With Spinal Metastases

University Health Network, Toronto100 enrolled

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.

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

100

Conditions

Spinal Metastases

Interventions

RadiotherapyRADIATION

Standard of care radiotherapy administered as per institutional guidelines.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University Health Network

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 2 years

Secondary Outcomes

Assess local progression free survival.

Based on available imaging, compare local progression free survival outcomes of patients treated with SBRT vs CRT.

Time frame: 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.

Time frame: 2 years

Assess adverse events

Compare adverse events, collected through standard of care follow up, which occur for patients treated with SBRT vs CRT.

Time frame: 2 years

Measure overall survival

Compare overall survival, collected through medical records, for patients treated with SBRT vs CRT.

Time frame: 2 years

Central Contacts

David Shultz, MD

CONTACT

416-946-4501 david.shultz@rmp.uhn.ca

Data from ClinicalTrials.gov

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