- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02613312
Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma
April 8, 2024 updated by: Dennis Wigle, Mayo Clinic
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karlyn Pierson, RN
- Phone Number: 507-293-0807
- Email: pierson.karlyn@mayo.edu
Study Contact Backup
- Name: Bettie Lechtenberg, MBA
- Phone Number: 507-293-0807
- Email: lechtenberg.bettie@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Principal Investigator:
- Dennis A Wigle, MD, PhD
-
Contact:
- Karlyn E Pierson, RN
- Phone Number: 507-538-1960
- Email: pierson.karlyn@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival status upon review of patients every 6 months
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival as evidenced by CT scan review
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dennis Wigle, MD, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2016
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 20, 2015
First Submitted That Met QC Criteria
November 23, 2015
First Posted (Estimated)
November 24, 2015
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 8, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pleural Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Neoplasms, Connective Tissue
- Neoplasms, Vascular Tissue
- Adenoma
- Neoplasms, Mesothelial
- Mesothelioma
- Mesothelioma, Malignant
- Hemangiopericytoma
- Solitary Fibrous Tumors
- Neoplasms, Fibrous Tissue
- Solitary Fibrous Tumor, Pleural
- Pleural Neoplasms
Other Study ID Numbers
- 15-007645
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mesothelioma
-
University of ChicagoNational Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Peritoneal Malignant Mesothelioma | Pleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Pleural Malignant Mesothelioma | Pleural Sarcomatoid Mesothelioma | Recurrent Peritoneal Malignant Mesothelioma | Recurrent Pleural Malignant Mesothelioma and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)TerminatedEpithelioid Mesothelioma | Sarcomatoid Mesothelioma | Stage IV Pleural Mesothelioma | Recurrent Malignant Mesothelioma | Stage II Pleural Mesothelioma | Stage III Pleural MesotheliomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Stage III Pleural Malignant Mesothelioma AJCC v7 | Stage I Pleural Malignant Mesothelioma AJCC v7 | Stage IA Pleural Malignant Mesothelioma AJCC v7 | Stage IB Pleural Malignant Mesothelioma AJCC v7 | Stage II Pleural Malignant Mesothelioma AJCC...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
-
ProgenaBiomeRecruitingMesothelioma | Mesotheliomas Pleural | Mesothelioma Peritoneum | Mesothelioma Malignant | Mesothelioma; Lung | Mesothelioma; Liver | Mesothelioma; OmentumUnited States
-
NRG OncologyNational Cancer Institute (NCI)TerminatedPleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Stage I Pleural Malignant Mesothelioma AJCC v8 | Stage IA Pleural Malignant Mesothelioma AJCC v8 | Stage IB Pleural Malignant Mesothelioma AJCC v8 | Stage II Pleural Malignant Mesothelioma AJCC v8 | Stage IIIA Pleural Malignant...United States, Canada
-
National Cancer Institute (NCI)WithdrawnAMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural MesotheliomaRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma
-
National Cancer Institute (NCI)CompletedCediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By SurgeryRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States