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Metronomic neoadjuvant capecitabine and cyclophosphamide in huge (PCI>28) Pseudomyxoma peritonei (PMP) patients candidates to cytoreductive surgery (CRS) and hypertermic intraperitoneal chemotherapy (HIPEC).
EU CTIS ID: 2024-514329-42-00
What this study is testing
To evaluate the proportion of patients with complete cytoreduction after neoadjuvant metronomic approach with oral capecitabine and cyclophosphamide in patients affected by huge PMP.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Clinical/Histological diagnosis of pseudomyxoma peritonei (PMP).
- Patients must sign an informed consent document (ICD).
- Male and female patients with reproductive potential must use an approved contraceptive method.
- 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).
You likely can't join if
- 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.
See the full eligibility criteria
- Clinical/Histological diagnosis of pseudomyxoma peritonei (PMP).
- Patients must sign an informed consent document (ICD).
- Male and female patients with reproductive potential must use an approved contraceptive method.
- 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.
- Adequate bone marrow reserve: WBC count >3.0x10^9/L, absolute neutrophyl count >1.5x10^9/L, platelet count >100x10^9/L, and haemoglobin >10 g/d
- Hepatic: bilirubin < 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 xUL.
- Renal: Creatinine clearance >50 mL/min or serum creatinine <1.5 x UNL.
- Patients compliance and geographic proximity that allows for adequate follow-up.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.