Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients
Recruiting
Phase 2
Interventional Study
Pseudomyxoma Peritonei
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 76
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 31 (estimated)
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Other
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About This Trial
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 (C…
Trial Locations
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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 follo…
Contacts