Spine Cancer, Spine Metastases, Spine Tumor
Conditions
Brief summary
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.
Detailed description
This study is being done to collect information about patients undergoing separation surgery followed by radiation for the treatment of primary and metastatic spine disease. Participants will be asked to complete some patient reported outcome questionnaires and researchers will collect information from medical records to evaluate oncologic and hardware related outcomes.
Interventions
None listed
Sponsors
Ohio State University Comprehensive Cancer Center
Icotec Medical, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation therapy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 12, 18, 24 months | — |
| Local control of treated lesion based on radiographic review | 3, 6, 9, 12, 15, 16, 21, 24 months | 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 |
| Progression free survival | 3, 6, 9, 12, 15, 16, 21, 24 months | — |
Countries
United States
Contacts
CONTACTCourtney Wright
CONTACTAllison Garvin
PRINCIPAL_INVESTIGATORJames B Elder, MD
Ohio State University
Outcome results
None listed