Actively Recruiting
Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-09
200
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Spinal metastases are rapidly progressive, have poor prognosis, are extremely difficult to treat, and can effect patient quality of life and overall health. Immunotherapy is a type of standard of care therapy to boost or restore the ability of the immune system to fight cancer. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. A vertebroplasty is a procedure used to repair a bone in the spine that has a break caused by cancer, osteoporosis, or trauma. The purpose of this trial is to test different combinations of immunotherapy, stereotactic radiosurgery, and surgery to improve overall survival and quality of life in patients with spinal metastases.
CONDITIONS
Official Title
Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age with indeterminate spine metastasis
- Patients with cancer types requiring stereotactic radiation therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Disease visible by CT or MRI imaging
- Prior radiation allowed if deemed safe by radiation oncologist
- Tumor tissue available from biopsy or surgery for biomarker testing if possible
- Four or fewer consecutive spinal segments involved or separable tumor targets
- Ability and willingness to complete quality of life questionnaires in English or Spanish
You will not qualify if you...
- Patients younger than 18 years
- Unable to undergo standard MRI or CT myelogram for radiation planning
- Symptomatic spinal cord compression needing emergency surgery
- Pregnant or breastfeeding women
- Use of systemic therapy or immunosuppressive drugs (except immunotherapy) within 3-14 days before radiation
- Patients with stable or unstable spinal lesions based on SINS criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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