Actively Recruiting

Phase 2
Age: 18Years - 76Years
All Genders
NCT06800391

Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients

Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-01-30

31

Participants Needed

1

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients

Who Can Participate

Age: 18Years - 76Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical or histological diagnosis of Pseudomyxoma peritonei (PMP)
  • Peritoneal Cancer Index (PCI) greater than 28 based on chest and abdominal CT scan
  • Age 18 years or older and younger than 76 years
  • Performance Status (ECOG) less than 2
  • Adequate bone marrow function: WBC count over 3.0x10^9/L, neutrophil count over 1.5x10^9/L, platelet count over 100x10^9/L, hemoglobin over 10 g/dL
  • Adequate liver function: bilirubin less than 1.5 times upper limit of normal, alkaline phosphatase, AST and ALT less than 2.5 times upper limit
  • Adequate kidney function: creatinine clearance over 50 mL/min or serum creatinine less than 1.5 times upper limit
  • Ability to comply with study follow-up and live nearby
  • Signed informed consent
  • Use of approved contraception for males and females with reproductive potential
Not Eligible

You will not qualify if you...

  • Peritoneal Cancer Index (PCI) 28 or less based on chest and abdominal CT scan
  • Deficiency of DPD enzyme
  • Previous systemic chemotherapy or biological therapy
  • Use of other experimental drugs during the study
  • Pregnancy or breastfeeding
  • Serious or uncontrolled medical conditions or active infections affecting treatment eligibility
  • Disorders affecting drug absorption such as malabsorption, intestinal blockage, Crohn's disease, or ulcerative colitis
  • Psychiatric or neurological conditions preventing compliance with study procedures
  • History of other cancers unless cured for more than 5 years

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy, 20133

Actively Recruiting

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Research Team

A

Alessandra Raimondi, MD

CONTACT

S

Shigeki Kusamura, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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