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RecruitingObservational

A Prospective Registry of Patients Undergoing Surgical Decompression Followed by Radiation Therapy for Spine Tumors

NCT ID: NCT07225491Sponsor: Ohio State University Comprehensive Cancer CenterLast updated: 2025-12-19

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.

Outcome measures

Primary

  • Overall survival

    Time frame: 12, 18, 24 months

  • 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 months

  • Progression free survival

    Time frame: 3, 6, 9, 12, 15, 16, 21, 24 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (3)

University of Michigan

Ann Arbor, Michigan, 48109

Not Yet Recruiting
Nicholas Szerlip · Contact
Nicholas Szerlip, MD · Principal Investigator

Rutgers Robert wood Johnson Medical School

New Brunswick, New Jersey, 08901

Not Yet Recruiting
Christine Yohn · Contact
Jonathan Sherman, MD · Principal Investigator

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Recruiting
Allison Garvin · Contact
Brad Elder, MD · Principal Investigator