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Recruiting

NCT Number: NCT07225491

Spine Oncology Registry

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.

Recruiting

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Key information

Conditions

Spine Tumor Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Spinal Cord Diseases Spinal Cord Neoplasms Spine Cancer Spine Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 12, 18, 24 months

  2. Local control of treated lesion based on radiographic review

    Time frame: 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

  3. Progression free survival

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

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Garvin

CONTACT

[email protected]

Courtney Wright

CONTACT

[email protected]

6142934876

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Icotec Medical, Inc

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2035
Study completion
2037
First posted
Nov 6, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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