Actively Recruiting
A Prospective Registry of Patients Undergoing Surgical Decompression Followed by Radiation Therapy for Spine Tumors
Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-12-19
3000
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
I
Icotec Medical, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating outcomes for adults with primary or metastatic spine disease who undergo separation surgery followed by radiation treatment. This observational study aims to collect detailed information on the effects of these treatments, focusing on both cancer-related results and hardware performance. The study is sponsored by Ohio State University Comprehensive Cancer Center and seeks to understand the impact of surgery plus radiation on spine tumors. Participants will have undergone surgical decompression and stabilization followed by radiation therapy as part of their usual care. The study does not involve new treatments but collects data from patients receiving these standard procedures. There are no assigned study treatments; instead, researchers observe and gather information over time to assess outcomes related to tumor control and hardware. Participants will be asked to complete patient-reported outcome questionnaires. Researchers will also review medical records and imaging results such as MRI or CT scans to monitor survival, local tumor control, and progression-free survival at multiple time points up to 24 months. The study involves regular follow-up assessments to track both oncologic and hardware-related outcomes throughout the observation period.
CONDITIONS
Brief Title
Spine Oncology Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary or metastatic disease to the spine
- Undergoing surgical decompression and stabilization followed by radiation therapy
- Adults aged 18 years or older
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies per participant
Participants undergo surgical decompression and stabilization for spine tumors, followed by immediate post-operative care.
Duration - Varies per participant
Participants receive radiation therapy following surgery as part of their treatment for spine tumors.
Duration - Up to 24 months
Participants complete patient-reported outcome questionnaires and are monitored through medical record reviews to evaluate oncologic and hardware-related outcomes, including survival and local control.
Follow-up visits at approximately 3, 6, 9, 12, 15, 16, 21, and 24 months
Trial Site Locations
Total: 3 locations
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
2
Rutgers Robert wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
3
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
C
Courtney Wright
A
Allison Garvin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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