This phase II trial studies the side effects of surgery, chemotherapy, and intensity modulated radiation therapy in treating patients with stage I-III pleural mesothelioma. Drugs used in chemotherapy, such as pemetrexed disodium, cisplatin, and carboplatin, work in different ways to stop the growth of cancer, either by killing the cancer cells, by stopping them from dividing, or by stopping them from spreading. Intensity modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before radiation therapy may help kill more tumor cells after surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT00715611.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the safety and exportability of the Memorial Sloan Kettering Cancer Center (MSKCC) trimodality approach consisting of pleurectomy/decortication, adjuvant chemotherapy (neoadjuvant chemotherapy permissible as an alternative) and intensity modulated radiation therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma as indicated by the incidence of >= grade 3 pneumonitis in a multi-institutional setting.
SECONDARY OBJECTIVES:
I. To determine the progression free and overall survival rates of patients with malignant pleural mesothelioma treated with lung-sparing trimodality therapy to the pleura.
II. To determine the pattern of progression: local recurrence versus metastatic disease.
III. To determine the incidence of any IMRT-related grade 2 or greater toxicity.
IV. To determine the impact of trimodality therapy and pleural IMRT on patient-reported outcomes (PRO-Common Terminology Criteria for Adverse Events [CTCAE]).
V. To develop a prediction model of resectability and a prognostic multi-modality imaging model through magnetic resonance imaging (MRI), positron emission tomography (PET) and computed tomography (CT) imaging.
OUTLINE:
Patients undergo pleurectomy/decortication (P/D). Within 4-8 weeks after surgery, patients receive pemetrexed sodium intravenously (IV) over 10 minutes and cisplatin IV over 60 minutes or carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 4 cycles. Within 4-8 weeks of chemotherapy completion, patients undergo 28 fractions of IMRT over approximately 6 weeks. Patients undergo computed tomography (CT) and may optionally undergo magnetic resonance imaging (MRI) throughout the trial. Patients also receive fludeoxyglucose F-18 (FDG) and undergo positron emission tomography (PET) during screening and on the trial.
After completion of study treatment, patients are followed up at 1 month, then every 3 months for 2 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorCharles B. Simone