Neoadjuvant treatment for patients with advanced Pseudomyxoma peritonei

Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in Huge (PCI>28) Pseudomyxoma Peritonei Patients Candidates to Cytoreductive Surgery (CRS) and Hypertermic Intraperitoneal Chemotherapy (HIPEC)

This study is testing a new combination of medications to see if it can help patients with advanced Pseudomyxoma peritonei have better surgery results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 18 Years to 76 Years
• Sex: All
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Academic / other)
• Drugs / interventions: chemotherapy, cyclophosphamide
• Locations: 1 site (Milan)
• Trial ID: NCT06800391 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a clinical diagnosis of Pseudomyxoma peritonei and a peritoneal cancer index greater than 28.

Not a fit: Patients with a peritoneal cancer index of 28 or lower may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance surgical outcomes and improve quality of life for patients with advanced PMP.

How similar studies have performed: While metronomic chemotherapy approaches are gaining interest, this specific combination for huge PMP is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Milan

• 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

Conditions Pseudomyxoma Peritonei; Pseudomyxoma peritonei; metronomic regimen; capecitabine; cyclophosphamide; cytoreductive surgery; HIPEC; peritoneal cancer index