BridgeMD
New treatment option for Mesothelioma
Official title Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma
ClinicalTrials.gov ID: NCT07126509
What this study is testing
- What it's testing
- 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.
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Borderline resectable disease is defined by cross sectional imaging (CT or MRI) demonstrating extensive pulmonary parenchymal invasion (anticipated...
You likely can't join 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...
- 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.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- Prior or concurrent enrollment to UChicago's Mesothelioma Biobank (IRB15-0443).
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- 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 study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.