Neoadjuvant treatment for patients with advanced Pseudomyxoma peritonei

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a metronomic regimen of capecitabine and cyclophosphamide in patients with huge Pseudomyxoma peritonei (PMP), characterized by a peritoneal cancer index greater than 28. Participants will receive this treatment for six months before undergoing standard cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. The primary objective is to determine the proportion of patients achieving complete cytoreduction after this neoadjuvant approach. The study aims to improve surgical outcomes and reduce the extent of surgery required for these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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);
* Adequate organ function including the following:
* Adequate bone marrow reserve: WBC count \>3.0x109/L, absolute neutrophyl count \>1.5x109/L, platelet count \>100x109/L, and hemoglobin \>10 g/dL;
* Hepatic: bilirubin \< 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase \< 2.5 x UL;
* Renal: Creatinine clearance \>50 mL/min or serum creatinine \<1.5 x UNL;
* Patients compliance and geographic proximity that allows for adequate follow-up;
* Patients must sign an informed consent document (ICD);
* Male and female patients with reproductive potential must use an approved contraceptive method;

Exclusion Criteria:

* 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;
* Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment;
* Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis;
* Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures;
* Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years.

Where it's running

• Fondazione IRCCS Istituto Nazionale dei Tumori
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Alessandra Raimondi, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Study coordinator: Alessandra Raimondi, MD
• Email: alessandra.raimondi@istitutotumori.mi.it
• Phone: +39 02 2390 2581

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.