Spine Oncology Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center
About this trial
This is an observational study to evaluate hardware related and oncologic outcomes in adult patients with primary and metastatic spine disease undergoing separation surgery followed by radiation treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation therapy
Disqualifiers
Inability to obtain a standard MRI or CT / CT myelogram for radiation treatment planning and dosimetry
Inability to receive radiation treatment.
Patients under 18 years of age
Trial population
The study population will be comprised of patients with primary and metastatic spine disease who undergo surgery followed by radiation therapy. Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in this registry. Patients may be enrolled regardless of other current local or systemic treatments of disease extent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall survival
Time frame
12, 18, 24 months2
Local control of treated lesion based on radiographic review
Patients will be classified as achieving local control if demonstrating response of treated spine lesion after treatment. Local control will be assessed by comparing the radiographic images after treatment and prospectively every 3 months for up to 24 months
Time frame
3, 6, 9, 12, 15, 16, 21, 24 months3
Progression free survival
Time frame
3, 6, 9, 12, 15, 16, 21, 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University Comprehensive Cancer Center
Lead sponsor
Icotec Medical, Inc
Collaborator
Source ClinicalTrials.gov