Clinical Trial

Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients

Study acronym: REVERSE
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT06800391
Lead Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions Pseudomyxoma Peritonei
Enrollment 31 participants
Start Date 2024-11-22
Primary Completion 2027-11 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2025-01-30