💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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