ICARuS II (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multicenter, Randomized Phase II Trial of Normothermic Intraperitoneal Chemotherapy and Intravenous Chemotherapy After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Malignant Peritoneal Mesothelioma
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.
• Patient must be planning to undergo complete cytoreduction of all peritoneal disease.
• ECOG performance status ≤ 1.
• Hematology: ANC ≥ 1,500/µl.
• Platelets \> 75,000/µl.
• Adequate renal function: creatinine \< 1.5× the upper limit of normal (ULN) or calculated creatinine clearance of ≥50 ml/min.
• Adequate hepatic function: bilirubin \< 1.5 mg/dl (except in patients with Gilbert's syndrome, who must have total bilirubin \< 3.0 mg/dL).
• Women of childbearing potential with a negative pregnancy test result (urine or blood) who agree to use an effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
• A man participating in this study must agree to utilize a reliable barrier form of contraception for the duration of the study
• Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.