Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma

NCT07126509 | Recruiting DMC

• 1 other identifier: IRB25-1014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the study: The main purpose of this research study is to see if a surgery procedure (limited partial pleurectomy and decortication) helps symptoms in people who have cancer that is unresectable that might not be able to be removed completely. This is called unresectable cancer. This study will also help the research team learn more about the types of symptoms and quality of life for people who have undergone this surgery, the number of complications following , and the time from surgery to starting other therapy. Th e study team also wants to see see the overall survival of people who have had this procedure as part of their care. What will be done as part of research on this study:

• Surgery (Partial Pleurectomy - surgery to remove lining of lungs)
• The research team will also ask study participants questions about their symptoms through questionnaires at certain times after surgery. How long this study will last: Participation in this research (pre-surgery, surgery and follow-up) will last for about 2 years. Confidentiality: All personal information will be kept confidential, and data will be used only for research purposes. Contact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu

Conditions

Mesothelioma; Mesothelioma; Lung; Mesotheliomas Pleural; Mesothelioma Malignant Advanced; Mesothelioma, Malignant

Keywords

PLEURECTOMY

Outcome Measures

Primary Outcomes (1)

• Disease-related Symptom Burden 3 Months After Partial Pleurectomy (Surgery)

  The primary objective is to assess the post-operative disease-related symptom burden in participants undergoing partial pleurectomy and decortication for borderline or unresectable pleural mesothelioma, as measured by the mesothelioma-specific Lung Cancer Symptom Scale Average Symptom Burden Index (LCSS-meso ASBI) at 3 months post-surgery.

  3 months after surgery

Secondary Outcomes (4)

• Quality of Life of Study Participants Who Have Undergone Partial Pleurectomy (Surgery)

  2 years

• Rate of Complications after Partial Pleurectomy (Surgery)

  2 years

• Time to Resumption of Systemic Therapy

  2 years

• Overall Survival of Study Participants Who Have Undergone Partial Pleurectomy (Surgery)

  2 years

Study Arms (1)

All Study Participants

EXPERIMENTAL

This study arm will include all study participants receiving a partial pleurectomy (Surgery) for unresectable pleural mesothelioma. Participants in this study arm will all receive the same study procedures.

Procedure: Partial Pleurectomy

Interventions

Partial Pleurectomy PROCEDURE

A partial pleurectomy is a surgical procedure where part of the pleura, the lining of the lung cavity, is removed. This may be done to remove tumors, excess tissue, or to treat lung complications.

All Study Participants

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed epithelioid subtype pleural mesothelioma, as determined by surgical (i.e. VATS) biopsy.
• Disease confined to the unilateral hemithorax.
• Disease that is classified as unresectable or borderline resectable:
• Unresectable disease is defined by cross sectional imaging (CT or MRI) demonstrating invasion of unresectable mediastinal structures (heart, great vessels, esophagus) or spine, unresectable invasion of the chest wall (multifocal chest wall invasion or apical chest wall invasion), or disease outside intended resection field.
• Borderline resectable disease is defined by cross sectional imaging (CT or MRI) demonstrating extensive pulmonary parenchymal invasion (anticipated need for anatomic resection or complex wedge resection to clear disease) or extensive/bulky disease of (1) the diaphragm or sulci (anticipated need for diaphragm resection and reconstruction to clear disease), or (2) the chest wall (anticipated need for chest wall resection and reconstruction to clear disease). Disease with pathologically proven hilar or mediastinal lymph node involvement.
• Successful completion of at least 6 weeks of systemic induction therapy (regimen according to treating physician choice, including the below) with no unresolved adverse event that would preclude surgery:
• Platinum agent, pemetrexed, +/- bevacizumab
• Platinum agent, pemetrexed, pembrolizumab
• Ipilimumab/nivolumab
• Age ≥18 years.
• ECOG performance status ≤1.
• Patients must have adequate organ and marrow function as defined below:
• leukocytes ≥3,000/mcL
• absolute neutrophil count ≥1,500/mcL
• platelets ≥100,000/mcL

You may not qualify if:

• Patients with biphasic or sarcomatoid pleural mesothelioma.
• Patients with metastatic disease or disease which extends to the abdominal cavity or subdiaphragm as identified on post-induction therapy cross sectional imaging (CT, MRI, or PET).
• Patients who demonstrate disease progression during or following induction therapy.
• FEV1 \< 50% and/or postoperative predicted DLCO \< 50%.
• Patients who are receiving any other investigational agents.
• Patients with uncontrolled intercurrent illness.
• Prior malignancy active 2 years prior to registration except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast, or papillary thyroid.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Mesothelioma; Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Darren Bryan, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Trials Intake

CONTACT

1-855-702-8222; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)