Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Les… (NCT05178472) | Clinical Trial Compass
RecruitingNot Applicable
Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
United States200 participantsStarted 2023-03-27
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 wi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vertebral compression fracture (VCF) rate
Timeframe: At 6 months
2
Local control
Timeframe: At 6 months
Trial details
NCT IDNCT05178472
SponsorOhio State University Comprehensive Cancer Center
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-12-31
Contact for this trial
The Ohio State University Comprehensive Cancer Center