Combining vertebroplasty and radiation therapy for spine cancer patients
Part A: Effect of Prophylactic Vertebroplasty Combined With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)
This study is testing whether combining a special type of radiation therapy with a procedure to strengthen the spine can help people with tough-to-treat cancer in that area feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05178472 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with indeterminate spine metastases from specific radiation-resistant cancers.
Not a fit: Patients with extensive spinal involvement or those with poor performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with challenging spinal metastases.
How similar studies have performed: While there have been studies on individual components like stereotactic radiosurgery and vertebroplasty, this specific combination approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.