The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.
Patient age 18 years or older, both sexes.
Clinical diagnosis of MPM at enrolling institution.
Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM at enrolling institution.
Complete or near-complete CRS achieved.
Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy for peritoneal mesothelioma.
Subjects who have previously received platinum-containing chemotherapy regimens.
Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.
Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for which observation over two years is a reasonable option.
Memorial Sloan Kettering Cancer Center
Lead sponsor