Combining vertebroplasty and radiation therapy for spine cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of stereotactic radiosurgery (SRS) combined with vertebroplasty or separation surgery in patients with radiation-resistant metastatic cancer in the spine. The study aims to evaluate various outcomes, including overall survival, local control of the disease, and quality of life improvements. Patients will be randomized into two groups to assess the impact of these interventions on their condition. Additionally, the trial will explore molecular biomarkers that may predict treatment responses and disease progression.

Why it matters

Who can join: the full rules

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 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

Where it's running

• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Dukagjin M Blakaj, MD — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 800-293-5066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.