Partial Pleurectomy Surgery for Unresectable Pleural Mesothelioma

This study is looking at a surgery called a partial pleurectomy for people with mesothelioma, a type of cancer that affects the lining of the lungs (pleura). This surgery removes part of the pleura. The study is for people whose mesothelioma is considered "unresectable," meaning it can't be completely removed by standard surgery. Researchers want to see if this surgery helps with symptoms, understand the quality of life for patients after surgery, track any complications, and learn about how long people live after the procedure. You may be able to join if you have a specific type of pleural mesothelioma (epithelioid subtype) that is confined to one side of your chest and is considered unresectable or borderline resectable. The study plans to enroll 30 participants.

Study design
This is an interventional study that plans to enroll 30 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures symptom burden 3 months after surgery, indicating follow-up for at least that duration.

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NCT07126509

Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma

Recruiting
NAAges 18+InterventionalTreatment
University of Chicago
~30 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Partial Pleurectomy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-related Symptom Burden 3 Months After Partial Pleurectomy (Surgery)
Measured over 3 months after surgery
Mesothelioma
Mesothelioma; Lung
Mesotheliomas Pleural
Mesothelioma Malignant Advanced
Mesothelioma, Malignant
1 sites across 1 states
Illinois1
  • Darren Bryan, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

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Eligibility criteria

Inclusion

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
PT/INR \>1.5
PTT \>Upper limit of normal
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
creatinine within normal institutional limits OR
creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification21. To be eligible for this trial, patients should be class 2B or better.
Review by multidisciplinary treatment conference consisting of mesothelioma surgeons, radiologists, pathologists, medical oncologists, and palliative care physicians. Date of review will be documented in on the patient's elgibility checklist
Prior or concurrent enrollment to UChicago's Mesothelioma Biobank (IRB15-0443).
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

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