Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-76
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day

Treatment groups

31 Participants
are divided into 1 treatment group