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);
Peritoneal Cancer Index (PCI ≤28) assessed by chest and abdominal CT scan at the staging phase;
DPD deficiency;
Previous systemic chemotherapy and/or biological therapy;
Administration of other experimental drugs during the study Pregnancy and breast-feeding;
Single group
Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day
Combination productCapecitabine (1250 mg/m2 /day) and Cyclophosphamide (50 mg/day) continuous daily dosing. Cycles are to be repeated every 28 days for a total of 6 cycles.
The proportion of patients with complete cytoreduction after neoadjuvant metronomic approach with oral capecitabine and cyclophosphamide in patients affected by huge PMP.
Use of Completeness of Cytoreduction score to evaluate the radicality of Cytoreductive Surgery. Patients with a residual disease \<2.5 mm will be considered completely cytoreduced, otherwise incompletely cytoreduced. "Completeness of Cytoreduction Score" ranging from the best cc-0: no peritoneal nodule was seen, afterwards cc-1,tumor nodules persisting after cytoreduction are less than 2.5 mm in diameter, then cc-2, tumor nodules persisting after cytoreduction are between 2.5 mm and 2.5 cm in diameter to the worst cc-3, tumor nodules persisting after cytoreduction are greater than 2.5 cm
Radiological objective tumor response rate.
Objective tumor response rate will be defined by two independent radiologists by means of CT (computed tomography) scans. Tumour response will be determined semiquantitatively as either stable, reduced or progressed.
Conversion rate
Conversion rate will be calculated dividing the number of resectable cases after the neoadjuvant chemotherapy by the number of resectable cases before neoadjuvant chemotherapy. Resectability will be evaluated with CT scans using Bouquot et al. methodology.
Downsizing of the tumor measured by surgical Peritoneal Cancer index (PCI).
Downsizing of the tumor will be measured at the time of staging laparoscopy and CRS using Peritoneal Cancer Index (PCI). Peritoneal cancer index (PCI) ranging from the best 0 to the worst 39.
Safety and tolerability of neoadjuvant metronomic chemotherapy.
Incidence of Treatment-Emergent Adverse Event will be measured using NCI-CTCAE v5.
Effect of neoadjuvant metronomic chemotherapy on the immunocompetence of tumor microenvironment
Conduction of biological studies with exploratory nature and therefore without the possibility to be categorized according to specific scale of range.
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