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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

At least 18 years of age and older with indeterminate Spine Metastasis.

All patients with histology that requires stereotactic RT as a part of their treatment.

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Disease visualized by CT or MRI

Disqualifiers

Patients < 18 years of age

Inability to get a standard MRI or CT myelogram for radiation treatment target delineation

Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating radiation oncologist.

Patients with symptomatic spinal cord compression requiring emergent surgery

Trial design

Treatments tested in this trial

  • Immunotherapy
  • Stereotactic Radiosurgery
  • Vertebroplasty

Treatment groups

200 Participants
are divided into 2 treatment groups