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

NCT02613312 | Terminated

• 2 other identifiers: 15-007645NCI-2024-02057
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesothelioma; Solitary Fibrous Tumor of the Pleura

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as the length of time from study enrollment to death by any cause. Survival status of patients will be monitored every 6 months

  2 years

Secondary Outcomes (1)

• Progression free survival (PFS) as evidenced by CT scan review

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subject is \<18 years old.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Mesothelioma; Solitary Fibrous Tumor, Pleural

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Solitary Fibrous Tumors; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Dennis Wigle, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: March 18, 2016
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

US (1)