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Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT02613312
Collaborator
(none)
200
Enrollment
1
Location
80.5
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the response rate and overall survival in patients that have been diagnosed with mesothelioma and will undergo chemotherapy, surgery and intensity modified radiation therapy (IMRT) as part of their standard of care.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators will consent patients that have been diagnosed with mesothelioma and will undergo chemotherapy followed by surgery and then IMRT 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma
    Actual Study Start Date :
    Mar 18, 2016
    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 patients every 6 months [2 years]

    Secondary Outcome Measures

    1. Progression free survival as evidenced by CT scan review [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 chemotherapy followed by surgery and then IMRT

    • 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:
    NCT02613312
    Other Study ID Numbers:
    • 15-007645
    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:
    Mesothelioma
    Mesothelioma, Malignant
    Neoplasms, Fibrous Tissue
    Solitary Fibrous Tumors
    Hemangiopericytoma
    Pleural Neoplasms
    Solitary Fibrous Tumor, Pleural

    Study Results

    No Results Posted as of Sep 17, 2021