RecruitingNot applicable

Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma

A Pilot Study of Partial Pleurectomy in Borderline and Unresectable Pleural Mesothelioma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether surgery to remove part of the lining around the lung helps ease symptoms from pleural mesothelioma, a cancer in that lining. It is for adults whose cancer cannot be fully removed or may be hard to remove fully. The study also tracks quality of life, surgery problems, time to other treatment, and survival over about 2 years.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to do most daily activities with little or no trouble.
  • Have the epithelioid type of pleural mesothelioma, confirmed by a tissue sample taken during surgery.
  • Have cancer limited to one side of the chest that scans show cannot be fully removed or may be hard to remove fully.
  • Have finished at least 6 weeks of drug treatment for cancer, with no lasting side effects that would prevent surgery.
  • Meet the study’s blood count, blood clotting, liver, kidney, and, if needed, heart function requirements.
  • If you have HIV or hepatitis B, meet the study’s treatment and virus-level rules. Hepatitis C must be cured or under treatment with no virus found in blood tests.
  • Have your case reviewed by the study’s team of specialists, and join or already belong to UChicago’s Mesothelioma Biobank.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Have the biphasic or sarcomatoid type of pleural mesothelioma.
  • Have cancer that has spread to distant parts of the body, into the belly, or below the diaphragm, the muscle beneath the lungs, on scans after initial drug treatment.
  • Have cancer that gets worse during or after initial drug treatment.
  • Have lung test results below 50% for FEV1, which measures air breathed out, or predicted lung gas transfer after surgery.
  • Be receiving another experimental drug.
  • Have another illness that is not under control.
  • Have had another cancer active within 2 years before joining, except certain cancers that appear cured with local treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * 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 Criteria * 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.

Study sites (1)

IL