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

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ClinicalTrials.gov Identifier: NCT02613312
Recruitment Status : Recruiting
First Posted : November 24, 2015
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

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.

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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 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma




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 ]


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.


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

Additional Information:
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Responsible Party: Dennis Wigle, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02613312     History of Changes
Other Study ID Numbers: 15-007645
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Mesothelioma
Neoplasms, Fibrous Tissue
Solitary Fibrous Tumors
Pleural Neoplasms
Solitary Fibrous Tumor, Pleural
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Diseases
Respiratory Tract Diseases