Clinical trial: Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma (NCT00715611)

Eligibility criteria:
Inclusion Criteria:

          -  Provide written informed consent to participate on the study

          -  Patients must have a pathologically confirmed diagnosis either at MSKCC or at the
             participating site of stage I-III malignant pleural mesothelioma

          -  Epithelioid or biphasic histology subtype (Note: patients with biphasic histology can
             have < 10% sarcomatoid)

          -  No evidence of metastatic disease.

          -  Patient age ≥ 18 years but ≤ 80 years at the time of consent.

          -  Karnofsky performance status ≥ 80%

          -  Pulmonary Function Tests:

               1. For all patients: DLCO > 40% predicted (corrected for Hgb)

               2. For patients enrolled post-P/D, only: FEV1 >/= 35% (corrected for Hgb) (Note:
                  patients enrolled prior to P/D will have PFTs repeated pre-IMRT. If this criteria
                  is not met, they will be removed from study)

          -  In cases of concern about decreased renal function and potential high radiation dose
             to the kidneys, an optional nuclear medicine kidney function scan may be performed
             prior to radiation therapy to determine the functional contribution of each kidney.

          -  Patient enrolled prior to chemotherapy must have adequate organ function as indicated
             by the following laboratory values:

               1. Absolute neutrophil count ≥1.5 K/mcL

               2. Platelets ≥100 K/mcL

               3. Serum total bilirubin ≤ 1.5 X ULN

               4. AST (SGOT) or ALT (SGPT) ≤ 3.0 X ULN Note: patients enrolled after chemotherapy
                  do not have to meet the above criteria

        Exclusion Criteria:

          -  > 10% Sarcomatoid or desmoplastic histology

          -  Continuous oxygen use

          -  Prior nephrectomy on the contralateral side of MPM

          -  Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of
             P/D (i.e.: intrapleural chemotherapy, photodynamic therapy, intrapleural betadine)

          -  Prior thoracic radiation therapy preventing hemithoracic pleural IMRT

          -  Bulky disease in the fissure preventing lung-sparing pleural IMRT

          -  Patients undergoing extrapleural pneumonectomy

          -  Patients with an active infection that require systemic antibiotics, antiviral, or
             antifungal treatments

          -  Patients with a concurrent active malignancy (except squamous or basal cell carcinoma
             of the skin)

          -  Patients with serious unstable medical illness

          -  Presence of third space fluid that cannot be controlled by drainage

          -  For patients who develop or have baseline clinically significant pleural effusions
             before or during initiation of pemetrexed therapy; consideration should be given to
             drain the effusion prior to chemotherapy administration

          -  No acute congestive heart failure

          -  Pregnant or lactating women

          -  Men or women not using effective contraception

        Reproductive risks Patients should not become pregnant or father a baby while on this study
        because the drugs in this study can affect an unborn baby. Women should not breast-feed a
        baby while on this study. Women of childbearing age will be counseled to use birth control
        while on this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment