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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02613312
Recruitment Status : Recruiting
First Posted : November 24, 2015
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

Study Description
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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
Mesothelioma Solitary Fibrous Tumor of the Pleura

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
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Study Type : Observational
Estimated 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 : March 18, 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Survival status upon review of patients every 6 months [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progression free survival as evidenced by CT scan review [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving treatment at the Mayo Clinic Rochester that have been diagnosed with mesothelioma and will undergo chemotherapy followed by surgery and then IMRT as their standard of care.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613312


Contacts
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Contact: Karlyn Pierson, RN 507-293-0807 pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg, MBA 507-293-0807 lechtenberg.bettie@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karlyn E Pierson, RN    507-538-1960    pierson.karlyn@mayo.edu   
Principal Investigator: Dennis A Wigle, MD, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Dennis Wigle, MD, PhD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Dennis Wigle, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02613312    
Other Study ID Numbers: 15-007645
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Solitary Fibrous Tumors
Hemangiopericytoma
Neoplasms, Fibrous Tissue
Pleural Neoplasms
Solitary Fibrous Tumor, Pleural
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
Pleural Diseases