CAPECITABINE for Pseudomyxoma peritonei

Inclusion criteria

• {"criterion_text":"- Clinical/Histological diagnosis of pseudomyxoma peritonei (PMP)."}
• {"criterion_text":"- Peritoneal Cancer Index (PCI > 28) assessed by chest and abdominal CT scan at the staging phase."}
• {"criterion_text":"- Age >= 18 years and <76 years"}
• {"criterion_text":"- Performance Status (ECOG <2)."}
• {"criterion_text":"- Adequate organ function."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Hepatic: bilirubin < 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 xUL."}
• {"criterion_text":"- Renal: Creatinine clearance >50 mL/min or serum creatinine <1.5 x UNL."}
• {"criterion_text":"- Patients compliance and geographic proximity that allows for adequate follow-up."}
• {"criterion_text":"- Patients must sign an informed consent document (ICD)."}
• {"criterion_text":"- Male and female patients with reproductive potential must use an approved contraceptive method."}

Exclusion criteria

• {"criterion_text":"- Peritoneal Cancer Index (PCI < 28) assessed by chest and abdominal CT scan at the staging phase."}
• {"criterion_text":"- DPD deficiency."}
• {"criterion_text":"- Previous systemic chemotherapy and/or biological therapy."}
• {"criterion_text":"- Administration of other experimental drugs during the study."}
• {"criterion_text":"- Pregnancy and breast-feeding."}
• {"criterion_text":"- Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment."}
• {"criterion_text":"- Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis."}
• {"criterion_text":"- Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures."}
• {"criterion_text":"- Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years."}

Primary endpoints

• {"endpoint_text":"- We will use Completeness of Cytoreduction to evaluate the radicality of CRS: patients with a residual disease <2.5 mm will be considered completely cytoreduced, otherwise incompletely cytoreduced,","definition_or_measurement_approach":"Completeness of Cytoreduction: patients with a residual disease <2.5 mm will be considered completely cytoreduced; otherwise incompletely cytoreduced."}

Secondary endpoints

• {"endpoint_text":"- Objective tumor response rate will be defined by two independent radiologists by means of CT (computed tomography) scans performed at baseline, and after 16 weeks.","definition_or_measurement_approach":"Defined by two independent radiologists using CT scans at baseline and after 16 weeks."}
• {"endpoint_text":"- Conversion rate will be calculated dividing the number of resectable cases after the neoadjuvant chemotherapy by the number of resectable cases before neoadjuvant chemotherapy. Resectability will be evaluated with CT scans using Bouquot et al. methodology.","definition_or_measurement_approach":"Conversion rate = (number of resectable cases after neoadjuvant chemotherapy) / (number of resectable cases before neoadjuvant chemotherapy); resectability assessed on CT using Bouquot et al. methodology."}
• {"endpoint_text":"- Downsizing of the tumor will be measured at the time of staging laparoscopy and CRS using Peritoneal Cancer Index (PCI).","definition_or_measurement_approach":"Measured using Peritoneal Cancer Index (PCI) at staging laparoscopy and at CRS."}
• {"endpoint_text":"- Safety and tolerability objective will be measured by the incidence of adverse events (AEs), serious adverse events (SAEs), deaths, and laboratory abnormalities.","definition_or_measurement_approach":"Incidence of AEs, SAEs, deaths, and laboratory abnormalities."}
• {"endpoint_text":"- Major complications associated with CRS and HIPEC will be measured using NCI-CTCAE v5.","definition_or_measurement_approach":"Measured and graded according to NCI-CTCAE v5."}
• {"endpoint_text":"- Quality of life will be assessed before/after neoadjuvant metronomic chemotherapy, and 30 days after the surgery with EORTC-QLQ-30 and EQ-5D-5L.","definition_or_measurement_approach":"Patient-reported QoL assessed with EORTC-QLQ-30 and EQ-5D-5L at specified timepoints (before/after chemo and 30 days post-surgery)."}
• {"endpoint_text":"- Progression-free Survival (PFS) is the time between the date of chemotherapy commencement and the date of Disease-Progression or Death, whichever occurs first.","definition_or_measurement_approach":"PFS defined as time from chemotherapy start to disease progression or death (whichever occurs first)."}
• {"endpoint_text":"- Overall Survival (OS) is the time between the date of chemotherapy commencement and date of Death or last follow up.","definition_or_measurement_approach":"OS defined as time from chemotherapy start to death or last follow-up."}
• {"endpoint_text":"- Conduction of biological studies.","definition_or_measurement_approach":"Biological studies will be conducted (no further measurement details provided)."}

Italy

Earliest CTIS Part Ii Submission Date

13-08-2024

Latest Decision Or Authorization Date

23-09-2024

Processing Time Days

41

Number Of Sites

1

Number Of Participants

31

Primary sponsor

Full Name

Fondazione IRCCS Istituto Nazionale Dei Tumori

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"AIRC (Italian Association for Cancer Research)","duties_or_roles":"Monetary support","organisation_type":""}