NCT05589701

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Dec 2022Dec 2027

First Submitted

Initial submission to the registry

October 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

October 17, 2022

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

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).

    2 years

Secondary Outcomes (4)

  • Assess local progression free survival.

    2 years

  • Measure pain response

    2 years

  • Assess adverse events

    2 years

  • Measure overall survival

    2 years

Study Arms (2)

Stereotactic Radiotherapy (SBRT)

Standard of care stereotactic radiotherapy.

Radiation: Radiotherapy

Conventional Radiotherapy (CRT)

Standard of care conventional radiotherapy.

Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION

Standard of care radiotherapy administered as per institutional guidelines.

Conventional Radiotherapy (CRT)Stereotactic Radiotherapy (SBRT)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 1X6, Canada

RECRUITING

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 21, 2022

Study Start

December 12, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations