PMP PSEUDOMYXOMA PERITONEI MedDRA version: 21.0 Level: PT Classification code 10061269 Term: Malignant peritoneal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: CAPECITABINA ACCORD - 500 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 120X1 COMPRESSE (DOSE UNITARIA)
Product Name: Capecitabina
Pharmaceutical Form: Film-coat
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of pseudomyxoma peritonei (PMP) 2.Assessment of KRAS mutation on surgical sample 3. Patients submitted to a complete cytoreductive surgery and HIPEC for PMP 4. Age >= 18 years and 3.0x109/L, absolute neutrophyl count >1.5x109/L, platelet count >100x109/L, and hemoglobin >10 g/dL Hepatic: bilirubin 50 mL/min or serum creatinine 1.5 x UNL 7. Patients compliance and geographic proximity that allows for adequate follow-up 8. Patients must sign an informed consent document (ICD) 9. Male and female patients with reproductive potential must use an approved contraceptive method. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: 1.Previous systemic chemotherapy and/or biological therapy 2.Administration of other experimental drugs during the study 3.Pregnancy and breast-feeding 4. Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment 5.Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis 6.Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures 7. Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of postoperative capecitabine in terms of progression free survival (PFS) after Cytoreduction CRS and HIPEC in PMP patients with KRAS mutated .;Secondary Objective: 1.To assess the efficacy of adjuvant capecitabine treatment in terms of overall survival (OS) and disease specific survival (DSS). 2.To evaluate the feasibility and safety of the capecitabine administered in patients previously treated with CRS and HIPEC ;Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: PFS will be measured from the date of randomization to the date of radiological / clinical progression of the disease or death (depending on what occurs first) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: Overall Survival will be measured from the date of randomization to the date of death | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Outcome results
None listed