Clinical trial · Interventional
Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients
Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in Huge (PCI>28) Pseudomyxoma Peritonei Patients Candidates to Cytoreductive Surgery (CRS) and Hypertermic Intraperitoneal Chemotherapy (HIPEC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pseudomyxoma Peritonei | Pseudomyxoma Peritonei | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine and Cyclophosphamide
- description
- Capecitabine (1250 mg/m2 /day) and Cyclophosphamide (50 mg/day) continuous daily dosing. Cycles are to be repeated every 28 days for a total of 6 cycles.
- interventionNames
- Combination Product: Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day
Primary outcomes (1)
- measure
- The proportion of patients with complete cytoreduction after neoadjuvant metronomic approach with oral capecitabine and cyclophosphamide in patients affected by huge PMP.
- timeFrame
- 6-8 months from the start of treatment
- description
- Use of Completeness of Cytoreduction score to evaluate the radicality of Cytoreductive Surgery. Patients with a residual disease \<2.5 mm will be considered completely cytoreduced, otherwise incompletely cytoreduced. "Completeness of Cytoreduction Score" ranging from the best cc-0: no peritoneal nodule was seen, afterwards cc-1,tumor nodules persisting after cytoreduction are less than 2.5 mm in diameter, then cc-2, tumor nodules persisting after cytoreduction are between 2.5 mm and 2.5 cm in diameter to the worst cc-3, tumor nodules persisting after cytoreduction are greater than 2.5 cm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 76 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available