Clinical trial · Interventional
Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients
Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients Treated With CYTOREDUCTIVE SURGERY (CRS) and HYPERTERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC)
NCT05321329CI-TRIAL-00057704ACAPPunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a phase II, mono institutional, non comparative study, evaluating adjuvant capecitabine in patients affected by KRAS mutated Pseudomyxoma peritonei treated with cytoreductive surgery and HIPEC. Patient will be treated with 8 cycles of the study regimen that include: Capecitabine 1250 mg/m2 PO BID day 1-14 q21 days
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 | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Capecitabine will be taken orally at dose of 1250 mg/m2 PO BID on days 1→14 every 3 weeks Cycles are to be repeated every 21 days for a total of 8 cycles
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Progression free survival is time between treatment start date and first date of recurrence or death, whichever occurs first.
- description
- To evaluate the efficacy of postoperative capecitabine in terms of progression free survival (PFS) after CRS and HIPEC in patients with KRAS mutated PMP with extensive peritoneal disease
Secondary outcomes (2)
- measure
- OS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: * Patients submitted to a complete cytoreductive surgery and subsequent HIPEC for PMP * Histological diagnosis of pseudomyxoma peritonei (PMP) * Assessment of KRAS mutation positivity on surgical sample * 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 xULN * 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: * 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
No reference posted for this study.