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Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma

Published: October 12, 2016

Primary Outcome Measures

  • Dose limiting toxicities (DLT) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes]
    The NCI Common Terminology Criteria for Adverse Events version 4.0 will be used to grade toxicities during the trial. DLTs are defined as any of the following events occurring during and for the first 12 weeks after completing pleural IMRT


Inclusion Criteria
Pathologically confirmed diagnosis of malignant pleural mesothelioma at MSKCC
No plans for surgical resection
Stage T1-4, N0-3, M0
No prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose
Prior chemotherapy regimens ≤1
Age ≥18 years
Karnofsky performance status ≥ 80%
Pulmonary function tests as follows: DLCO>50% predicted
Adequate hematologic, hepatic, and renal function as indicated by the following laboratory values

  1. Absolute neutrophil count ≥ 1,500/mcL
  2. Platelets ≥ 100,000/mcL
  3. Calculated creatinine clearance (CrCl) ≥ 45mL/min (using Cockcroft & Gault method)
  4. Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless known Gilbert’s disease)
  5. AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN
Exclusion Criteria
Pregnant or lactating women, or men or women not using effective contraception
Patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments
Patients with a concurrent active malignancy (with the exception of skin cancer)
Patients with serious unstable medical illness
Patients with idiopathic pulmonary fibrosis
Patients with NYHA heart failure class >2
Patients with only one kidney that is ipsilateral to the mesothelioma
Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be moved
Patients meeting the following exclusion criteria will be excluded from the MRI portion only
Metallic implant, e.g. pacemaker, defibrillator
Unmanageable claustrophobia
High risk for nephrogenic systemic fibrosis
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