MesotheliomaNCT07126509
Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma
A study testing Partial Pleurectomy in people with Mesothelioma and Mesothelioma; Lung, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Mesothelioma; Lung, Mesotheliomas Pleural
- What is being tested?
- Partial Pleurectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 28Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Cancer Trial Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Darren Bryan, MD
About this study
Official title: A Pilot Study of Partial Pleurectomy in Borderline and Unresectable Pleural Mesothelioma
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:
Read more
- 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
- Being tested
- Partial Pleurectomy
- Keywords
- PLEURECTOMY
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial PleurectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Partial Pleurectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (4)
Quality of Life of Study Participants Who Have Undergone Partial Pleurectomy (Surgery)
To longitudinally evaluate quality of life in patients who have undergone partial pleurectomy and decortication as assessed by quality of life questionnaires and patient reported outcomes.
Measured: 2 years
Rate of Complications after Partial Pleurectomy (Surgery)
To estimate the rate of complications following partial pleurectomy and decortication as assessed by treating investigator and clinical notes.
Measured: 2 years
Time to Resumption of Systemic Therapy
To determine time to resumption of systemic therapy following partial pleurectomy and decortication as assessed by treating investigator and clinical notes.
Measured: 2 years
Overall Survival of Study Participants Who Have Undergone Partial Pleurectomy (Surgery)
To estimate overall survival in participants who have undergone partial pleurectomy and decortication as assessed by treating investigator and clinical notes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start2 Dec 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darren Bryan, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126509
- Sponsor's protocol ID
- IRB25-1014
- Status last verified
- Feb 2026
- First submitted
- 11 Aug 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Partial Pleurectomy in Borderline and Unresectable Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT07126509
- Acronym / sponsor ID
- IRB25-1014
- Conditions
- Mesothelioma, Mesothelioma; Lung, Mesotheliomas Pleural, Mesothelioma Malignant Advanced, Mesothelioma, Malignant
- Keywords
- PLEURECTOMY
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | Experimental | Procedure: Partial PleurectomyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial PleurectomyA 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. | Procedure or surgery | All Study Participants |
Primary outcome
Disease-related Symptom Burden 3 Months After Partial Pleurectomy (Surgery)
Time frame: 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.
4 secondary outcomes
Quality of Life of Study Participants Who Have Undergone Partial Pleurectomy (Surgery)
Time frame: 2 years
Rate of Complications after Partial Pleurectomy (Surgery)
Time frame: 2 years
Time to Resumption of Systemic Therapy
Time frame: 2 years
Overall Survival of Study Participants Who Have Undergone Partial Pleurectomy (Surgery)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darren Bryan, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial Pleurectomy in people with Mesothelioma and Mesothelioma; Lung, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-related Symptom Burden 3 Months After Partial Pleurectomy (Surgery) (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.