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Comparing SBRT to CRT in Patients With Spinal Metastases

ConditionSpinal Metastases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk

Lymphoma, myeloma or germ cell malignancies

Trial population

Patients who have MRI- or CT-documented spinal metastases and are suitable for receiving radiation therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiotherapy

    Radiation

    Standard of care radiotherapy administered as per institutional guidelines.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Stereotactic Radiotherapy (SBRT)1 intervention
Group B: Conventional Radiotherapy (CRT)1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

Measure overall survival

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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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