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NCT Number: NCT05589701

Comparing SBRT to CRT in Patients With Spinal Metastases

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.

Recruiting

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Key information

Conditions

Spinal Metastases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, M5G 1X6, Canada

Location status: Recruiting

Location contact

David Shultz, MD.

CONTACT

[email protected]

416-946-4501 ext. 2121

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Standard of care radiotherapy administered as per institutional guidelines.

Primary outcomes

  1. Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation.

    Time frame: 2 years

    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).

Secondary outcomes

  1. Assess local progression free survival.

    Time frame: 2 years

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

  2. Measure pain response

    Time frame: 2 years

    Using a patient reported scale (0 (no pain) to 10 (worst pain imaginable)), compare pain outcomes of patients treated with SBRT vs CRT.

  3. Assess adverse events

    Time frame: 2 years

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

  4. Measure overall survival

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

David Shultz, MD

CONTACT

[email protected]

416-946-4501 ext. 2121

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: COMBAT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 21, 2022
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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