RECRUITING

Spine Radiosurgery for Symptomatic Metastatic Neoplasms

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Conditions

Metastatic Neoplasm to the SpineMetastatic NeoplasmRadiosurgeryExternal Beam Radiation TherapyStereotactic Body Radiation TherapySpine Stereotactic Radiosurgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.

Official Title

Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial

Quick Facts

Study Start:2025-08-31
Study Completion:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05617716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.
  2. * Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site to be treated with spine SBRT. This includes any previous radiation therapy where the treatment field overlaps with the anatomic site to be treated with spine SBRT (even if that previous radiation therapy was not for treatment of spinal disease). Systemic radiation therapy for metastatic disease such as Pluvicto also counts as previous radiation therapy.
  3. * Age \>18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval, Participant \< age 18 are excluded from this study.
  4. * Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.
  5. * Participant must have a worst pain score \< 2 of 10 according to the Brief Pain Inventory
  6. * Participant must have no intention of changing pain medications on the first day of SBRT
  7. * Participant must have a Spinal Instability score (SINS) ≤ 12
  8. * Participant must be a spine SBRT candidate per Radiation Oncology
  9. * Participant must have the ability to understand and the willingness to sign a written informed consent document
  1. * Participant receiving any other investigational agents.
  2. * Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to meet the primary endpoint
  3. * Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  4. * Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.
  5. * Participant is unable to receive MRI of the spine
  6. * Participant has a Spinal Instability in Neoplasia score (SINS) ≥ 12
  7. * Participant has received previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
  8. * Participant has more than 3 consecutive vertebral bodies in the SBRT treatment volume
  9. * Participant is not an SBRT candidate per radiation oncology discretion
  10. * Participant has a known primary and has an estimated median survival≤ 3 months
  11. * Participant has an unknown primary
  12. * Participant has a Brief Pain Inventory score \> 2
  13. * Participant has received previous radiation therapy involving the intended SBRT treatment field
  14. * Participant has received previous spinal surgical procedure involving the SBRT target volume. Biopsy is not considered a previous spinal surgical procedure.
  15. * Participant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression

Contacts and Locations

Study Contact

Lead Onco Nurse
CONTACT
405-271-8777
SCC-IIT-Office@ouhsc.edu
Shearwood McClelland III, MD
CONTACT
405-271-3016
Shearwood-McClelland@ouhsc.edu

Principal Investigator

Shearwood McClelland III, MD
PRINCIPAL_INVESTIGATOR
University of Oklahoma

Study Locations (Sites)

Johns Hopkins University Hospitals
Baltimore, Maryland, 21287
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Shearwood McClelland III, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-31
Study Completion Date2029-09-30

Study Record Updates

Study Start Date2025-08-31
Study Completion Date2029-09-30

Terms related to this study

Keywords Provided by Researchers

  • Radiosurgery
  • External Beam Radiation Therapy
  • Stereotactic Body Radiation Therapy
  • Spine Stereotactic Radiosurgery

Additional Relevant MeSH Terms

  • Metastatic Neoplasm to the Spine
  • Metastatic Neoplasm