Peritoneal carcinomatosis MedDRA version: 9.1 Level: LLT Classification code 10061344
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with peritoneal carcinomatosis from: -advanced ovarian cancer -colo-rectal cancer -small bowel cancer -gastric cancer -pseudomyxoma peritonei -peritoneal mesothelioma and other rare primary peritoneal cancer -recurrent abdominal and retroperitoneal sarcomatosis -positivity of peritoneal cytology -age >18 = 70 -no evidence of extra-abdominal disease -no intestinal obstruction -no evidence of renal, cardio-pulmunary, metabolic and liver failure -no previous abdominal radiotherapy 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -tumor mass greater than 1 cm after debulking -colo-rectal cancer: PCI > 22 -creatinine clearance < 60 ml/ min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Progression free survival (PFS);Secondary Objective: Toxicity and surgical complication;Primary end point(s): Overal survaival | — |
Countries
Italy