Primary Outcome Measures:
- To determine the overall 1-year survival rate.
Secondary Outcome Measures:
- To assess the overall toxicity of neoadjuvant multimodal therapy [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
- To compare documented toxicities with or without the addition of systemic chemotherapy. [ Time Frame: Weeks 3, 6 & 9 ] [ Designated as safety issue: Yes ]
- To determine if the addition of systemic chemotherapy to a neoadjuvant muti-modal regimen will have any impact on the 8 or 12 month progression free survival rate and overall survival among patients with pleural mesothelioma. [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
Detailed Description:
Current surgical and/or chemotherapeutic approaches for malignant pleural mesothelioma are unsatisfactory and have not been shown to significantly prolong survival, and often lead to worsened pulmonary function and quality of life. We will investigate whether a prospective trial of trimodal (surgery, pleural chemotherapy, and pleural radiation) therapy can improve the overall 1 year survival in patients with malignant pleural mesothelioma. The proposed treatment will include exploratory thoracoscopy, placement of Mediport catheters into the pleural space, intraoperative chemotherapy, repeated intraperitoneal chemotherapy, and intrapleural instillation of radioactive P32 to radiate the pleural surfaces. In addition, because this study is randomized, half the patients will receive an additional three intraveons systemic chemotherapy treatments of cisplatin and pemetrexed (Alimta) in tandem with their intrapleural chemotherapy (weeks 3, 6, and 9 only).
The potential significance of this research is that such treatment may render it less necessary to surgically remove the affected lungs in whole or in part, in order to achieve significant disease cytoreduction. We hope to alter the currently accepted paradigm that major lung surgery is an inescapable component of such treatment, and advance the concept that a combination of judicious preparative surgery, systemic chemotherapy, and locoregional drug treatment of the pleural surfaces may offer the best hope for prolongation of survival with intact lung function.
Criteria
- Inclusion Criteria
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- Histologically confirmed malignant mesothelioma, < 20% sarcomatoid type
- No radiographic or other imaging evidence of Stage IV (cardiac, mediastinal, peritoneal, other distant) disease.
- Ineligible for other high priority national or institutional study.
- Age >18 years [to physiologic 75 years].
- Life expectancy > 3 months.
