RECRUITING

Spine Radiosurgery for Symptomatic Metastatic Neoplasms

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.

Study Overview

Study Details

Study overview

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.

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

Spine Radiosurgery for Symptomatic Metastatic Neoplasms

Condition
Metastatic Neoplasm to the Spine
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University Hospitals, Baltimore, Maryland, United States, 21287

Oklahoma City

OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73117

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.
  • * 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.
  • * 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.
  • * Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.
  • * Participant must have a worst pain score \< 2 of 10 according to the Brief Pain Inventory
  • * Participant must have no intention of changing pain medications on the first day of SBRT
  • * Participant must have a Spinal Instability score (SINS) ≤ 12
  • * Participant must be a spine SBRT candidate per Radiation Oncology
  • * Participant must have the ability to understand and the willingness to sign a written informed consent document
  • * Participant receiving any other investigational agents.
  • * 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
  • * 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.
  • * Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.
  • * Participant is unable to receive MRI of the spine
  • * Participant has a Spinal Instability in Neoplasia score (SINS) ≥ 12
  • * Participant has received previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
  • * Participant has more than 3 consecutive vertebral bodies in the SBRT treatment volume
  • * Participant is not an SBRT candidate per radiation oncology discretion
  • * Participant has a known primary and has an estimated median survival≤ 3 months
  • * Participant has an unknown primary
  • * Participant has a Brief Pain Inventory score \> 2
  • * Participant has received previous radiation therapy involving the intended SBRT treatment field
  • * Participant has received previous spinal surgical procedure involving the SBRT target volume. Biopsy is not considered a previous spinal surgical procedure.
  • * Participant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Oklahoma,

Shearwood McClelland III, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

2029-09-30