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

Brief Summary

For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and implementation of standard pleurectomy/decortication (removal of the surface lining of the lung) performed at other centers. Patients will undergo pleurectomy/decortication chemotherapy and hemithoracic pleural IMRT to the pleura in patients with malignant pleural mesothelioma.

Tracking Information
First Received DateJuly 11, 2008
Last Changed DateFebruary 22, 2017
Start DateJuly 11, 2008
Anticipated Primary Completion DateJuly 2017
Primary Outcome Measures

number of patients ≥ grade 3 pneumonitis [Time Frame: 2 years]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Procedure: Pleurectomy/Decortication
  • Drug: pemetrexed and cisplatin or carboplatin
  • Radiation: Intensity Modulated Radiation Therapy
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment81
GenderAll
Ages18 Years - 80 Years
Accepts Healthy VolunteersNo
Contact Andreas Rimner, MD
Phone: 212-639-6025
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

- 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 prior to P/D, only: FEV1 >/= 35% (corrected for Hgb) or 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

- 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:

- 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.

Administrative Information
NCTIDNCT00715611
Responsible Party,
SponsorMemorial Sloan Kettering Cancer Center
Verification DateFebruary 2017
Mesothelioma Doctors by State
  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

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