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Vertebroplasty and Radiation for Spine Metastatic Cancer

This study is for patients with cancer that has spread to the spine (spinal metastases) and is resistant to radiation. Researchers are looking at how well stereotactic radiosurgery (a precise type of radiation) works, either alone or combined with vertebroplasty (a procedure to strengthen spinal bones) or separation surgery. They are also studying if adding immunotherapy (a treatment that boosts your immune system to fight cancer) helps. The main goals are to see how many people experience vertebral compression fractures and how well the treatment controls the cancer in the treated area after 6 months. You might be able to join if you are 18 or older, have spinal metastases that can be seen on a CT or MRI, and your doctor thinks stereotactic radiation is part of your treatment plan. The study is currently unclear on its recruitment status and plans to enroll 200 participants.

Study design
This interventional study plans to enroll 200 participants. It is investigating different treatment approaches for spinal metastases.
What's involved
You would undergo stereotactic radiosurgery, and potentially vertebroplasty or receive standard immunotherapy. The study will measure outcomes at 6 months.
Compensation
Not stated in the trial record.
Follow-up
The study measures primary outcomes like vertebral compression fracture rate and local control at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05178472

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

Recruiting
NAAges 18+InterventionalSupportive care
Ohio State University Comprehensive Cancer Center
~200 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:ImmunotherapyStereotactic RadiosurgeryVertebroplasty

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Vertebral compression fracture (VCF) rate
Measured over At 6 months
+1 more outcome measured

Conditions

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

Explore related trials

Hematologic NeoplasmMetastatic Malignant Neoplasm in the SpineSolid Neoplasm

NCT05178472

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Dukagjin M Blakaj, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Eligibility criteria

Inclusion

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
Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures.
Tumor tissue from the core biopsy or resected site of disease will be collected, if available for biomarker analyses.
Four or less consecutive spinal segments involved by tumor. Or four or less separate spinal tumor targets with a minimum of one vertebral body separation
Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or Spanish. The baseline assessment must be completed within required timelines. Inability (illiteracy in English or Spanish, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible

Exclusion

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
Pregnant or lactating women
Systemic therapy or immunosuppressive medications, excluding immunotherapy, within 3-14 days of radiation treatment, at the discretion of the treating radiation oncologist .
Patients with stable or unstable lesions based on SINS criteria

What this trial measures

  • Vertebral compression fracture (VCF) rateAt 6 months

    Will be summarized for all patients overall and by each cohort. The confidence interval of the overall VCF rate within 6 months will be calculated using binomial exact test for each cohort.

  • Local controlAt 6 months

    Will be summarized for all patients overall and by each cohort. Will be summarized using Kaplan-Meier survival analysis.