Surgery for Mesothelioma After Radiation Therapy "SMART" for Resectable Malignant Pleural Mesothelioma

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT02613299
Collaborator
(none)
200
1
85
2.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether radiation therapy decreases tumor size and tumor spread. The investigators will consent subjects that have been diagnosed with mesothelioma and will undergo radiation therapy followed by surgical resection as their standard of care. The investigators will collect data from past and future medical records as well as data regarding their health status for their lifetime by reviewing life status, treatment status and CT scans.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Surgery for Mesothelioma After Radiation Therapy "SMART" for Resectable Malignant Pleural Mesothelioma
    Study Start Date :
    Nov 1, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Survival status upon review of patient records every 6 months [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subject provides informed consent

    • Subject is >18 years of age

    • Subject is deemed competent for making medical decisions

    • Subject is scheduled to undergo radiation followed by extrapleural pneumonectomy.

    • Subject is a surgical candidate

    • A negative pregnancy test is required in women of child-bearing potential, as standard of care.

    Exclusion Criteria:
    • Subject is <18 years old.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Dennis Wigle, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Dennis Wigle, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02613299
    Other Study ID Numbers:
    • 15-007644
    First Posted:
    Nov 24, 2015
    Last Update Posted:
    Sep 17, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 17, 2021