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Pleurectomy/Decortication Followed By Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma

Published: September 7, 2016

Primary Outcome

  • number of patients ≥ grade 3 pneumonitis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Grade 3 pneumonitis is defined as symptomatic, interfering with ADL’s and requiring oxygen support as defined by the NCI Common Terminology Criteria (CTC) version 4.0 for toxicity and Adverse Event reporting.


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 amenable to P/D.
Epithelioid or biphasic histology subtype
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. FEV1 ≥ 35% (corrected for Hgb) of predicted postoperative (ppoFEV1) (as if the patient underwent a pneumonectomy) based on the following formula using the quantitative V/Q scan: °Predicted post-resection FEV1 = FEV1 x % perfusion to uninvolved lung from the quantitative V/Q scan report
DLCO > 40% predicted (corrected for Hgb)
Patient 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. Serum total bilirubin ≤ 1.5 X ULN
In cases of concern about renal toxicity from chemotherapy, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.
Reassessment after P/D: Confirmation of resection status postoperatively, prior to proceeding with adjuvant chemotherapy and pleural IMRT
Exclusion Criteria
Sarcomatoid or desmoplastic histology
Continuous oxygen use
Prior nephrectomy on the contralateral side of MPM
Prior systemic therapy (e.g. chemotherapy/biological agents) for mesothelioma
Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of P/D
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 dosing
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.

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