Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in Huge (PCI>28) Pseudomyxoma Peritonei Patients Candidates to Cytoreductive Surgery (CRS) and Hypertermic Intraperitoneal Chemotherapy (HIPEC)
The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant capecitabine and cyclophosphamide treatment in patients affected by huge Pseudomyxoma peritonei (PMP) (peritoneal cancer index \>28). Treatment consists of metronomic (low-dose medication for a prolonged time) of capecitabine plus cyclophosphamide for 6 months followed by standard of care cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The main question the trial aims to answer is which is the proportion of patients with complete cytoreduction at CRS/HIPEC after neoadjuvant metronomic approach with oral capecitabine and cyclophosphamide in patients affected by huge PMP.
• Clinical/Histological diagnosis of pseudomyxoma peritonei (PMP);
• Peritoneal Cancer Index (PCI \>28) assessed by chest and abdominal CT scan at the staging phase;
• Age \>= 18 years and \<76 years;
• Performance Status (ECOG \<2);
• Adequate organ function including the following:
• Adequate bone marrow reserve: WBC count \>3.0x109/L, absolute neutrophyl count \>1.5x109/L, platelet count \>100x109/L, and hemoglobin \>10 g/dL;
• Hepatic: bilirubin \< 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase \< 2.5 x UL;
• Renal: Creatinine clearance \>50 mL/min or serum creatinine \<1.5 x UNL;
• Patients compliance and geographic proximity that allows for adequate follow-up;
• Patients must sign an informed consent document (ICD);
• Male and female patients with reproductive potential must use an approved contraceptive method;