Fluorouracil for Colorectal cancer

Inclusion criteria

• {"criterion_text":"- Histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection)"}
• {"criterion_text":"- Curative (microscopically complete) surgery performed by laparotomy or laparoscopy"}
• {"criterion_text":"- presence of at least one of the following risk factors for the development of metacrhonous PM: • perforated primary tumor (any T, N0-2b, M0); • primary tumor infiltrating the visceral peritoneum (pT4a, N0-2b, M0), or directly invading adjacent organs (pT4b, N0-2b, M0);"}
• {"criterion_text":"- age >18;"}
• {"criterion_text":"- performance status 2 according to the WHO score"}
• {"criterion_text":"- willingness to start adjuvant s-CT and post-operative follow-up"}
• {"criterion_text":"- Signing of informed consent."}

Exclusion criteria

• {"criterion_text":"- active sepsis"}
• {"criterion_text":"- pregnancy or lactation in progress;"}
• {"criterion_text":"- psychiatric or neurological conditions such as to preclude protocol procedures"}
• {"criterion_text":"- contraindications to laparoscopy"}
• {"criterion_text":"- known hypersensitivity to oxaliplatin or other platinum containing compounds and/or to any of their excipients;"}
• {"criterion_text":"- history of previous malignancies treated in the last three years, excluding cutaneous"}
• {"criterion_text":"- spinocellular carcinoma and/or basocellular carcinoma; prior pre-operative radio-chemotherapy."}
• {"criterion_text":"- cardiac function impairment (history of previous heart failure or 40% FE); 3. renal impairment (serum creatinine >1.5 normal value or creatinine clearance 60 ml/min)"}
• {"criterion_text":"- liver function impairment (AST, ALT, bilirubin > 1.5 normal value)"}
• {"criterion_text":"- bone marrow function impairment (leukocytes 4000 / mm3, neutrophils 1500 /mm3, platelets 80000/mm3)"}
• {"criterion_text":"- lung function impairment (diagnosis of severe COPD or 50% FEV1 or 40% DLCO adjusted for age)"}
• {"criterion_text":"- renal impairment (serum creatinine >1.5 normal value or creatinine clearance 60 ml/min)"}
• {"criterion_text":"- extra-abdominal and/or hepatic metastases at the CT scan of the chest, abdomen and pelvis with intravenous contrast;"}
• {"criterion_text":"- severe complications (grade 3-4) after primary cancer surgery;"}
• {"criterion_text":"- haemorrhagic diathesis or coagulopathy"}

Primary endpoints

• {"endpoint_text":"- The efficacy of adjuvant PIPAC will be assessed by measuring peritoneal metastasis-free survival from the date of primary surgery to the date of MP diagnosis.","definition_or_measurement_approach":"Peritoneal metastasis-free survival measured from the date of primary surgery to the date of MP (peritoneal metastasis) diagnosis."}

Italy

Earliest CTIS Part Ii Submission Date

02-05-2024

Latest Decision Or Authorization Date

18-06-2024

Processing Time Days

47

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Fondazione IRCCS Istituto Nazionale Dei Tumori

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy