Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT05178472
Status
Recruiting
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Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Spine

Eligibility Criteria

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

Interventions

  • Immunotherapy — OTHER
    Receive SOC immunotherapy
  • Stereotactic Radiosurgery — RADIATION
    Undergo SRS
  • Vertebroplasty — PROCEDURE
    Undergo vertebroplasty

Study Details

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.

Key Dates

Start date
Mar 27, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (vertebroplasty)
    Patients undergo vertebroplasty and, 2-4 weeks later, undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies. Patients also receive standard of care immunotherapy IV every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm II (no vertebroplasty)
    Patients receive standard of care immunotherapy IV every 2 weeks for up to 6 months and undergo SRS over 1-3 fractions depending upon the number of affected vertebral bodies in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Vertebral compression fracture (VCF) rate [ Time Frame: At 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Dukagjin M. Blakaj
[email protected]
Dukagjin M. Blakaj (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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