Spine Radiosurgery for Symptomatic Metastatic Neoplasms

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Oklahoma
Study ID
NCT05617716
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Neoplasm
  • Metastatic Neoplasm to the Spine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional external beam radiation therapy dose (EBRT) — RADIATION
    Participants will undergo 8 Gray in 1 fraction of EBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
  • Spine radiosurgery/stereotactic body radiation therapy standard dose — RADIATION
    Participants will undergo 24 Gray in 2 fractions of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
  • Spine radiosurgery/stereotactic body radiation therapy high dose — RADIATION
    Participants will undergo 19 Gray in 1 fraction of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.

Study Details

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.

Key Dates

Start date
Sep 9, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard SBRT
    Participants will undergo standard dose Stereotactic Body Radiation Therapy as part of standard of care.
  • Experimental: High Dose SBRT (SOC)
    Participants will undergo high dose Stereotactic Body Radiation Therapy as part of standard of care.
  • Experimental: Conventional EBRT (SOC)
    Participants will undergo External Beam Radiation Therapy as part of standard of care.

Primary Outcome Measure

Proportion of patients who experience 3-month pain freedom based on BPI score [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins University HospitalsBaltimoreMaryland21287-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73117
Shearwood McClelland III, MD
[email protected]
405-271-3016

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University Hospitals· Baltimore, MDOU Health Stephenson Cancer Center· Oklahoma City, OK

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