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Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Summary
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.
Official title: Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in Huge (PCI>28) Pseudomyxoma Peritonei Patients Candidates to Cytoreductive Surgery (CRS) and Hypertermic Intraperitoneal Chemotherapy (HIPEC)
Key Details
Gender
All
Age Range
18 Years - 76 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2024-11-22
Completion Date
2029-11
Last Updated
2025-01-30
Healthy Volunteers
No
Conditions
Interventions
Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day
Capecitabine (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.
Locations (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy