adjuvant pressurized intraperitoneal aerosol chemotherapy to prevent colorectal peritoneal metastases (prophypipac)

Conditions: Peritoneal Metastases From Colorectal Cancer

Summary: the objective of this clinical trial is to demonstrate the feasibility and safety of pressurized intraperitoneal aerosol chemotherapy (pipac) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer.

this single-arm, single-center, open-label trial enrolls patients after curative-intent surgery for colon adenocarcinoma (proximal to peritoneal reflection), intestinal or mucinous histological type, associated with the following clinical-pathological risk factors for the development of peritoneal metastases: a) stage pt4a, n0-2b, m0 of the tumor node metastasis classification; b) stage pt4b, n0-2b, m0; and c) primary perforated tumor (any t, any n, m0). eligible patients who will give informed consent undergo laparoscopic pressurized intraperitoneal aerosol chemotherapy (pipac) 4 to 8 weeks after primary surgery, followed by adjuvant systemic chemotherapy according to according to current guidelines. after the procedure, patients will be followed-up to assess occurrence of adverse events,survival, peritoneal and systemic disease relapse, and quality of life.

Eligibility criteria:
inclusion criteria: 1. histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection); 2. curative (microscopically complete) surgery performed by laparotomy or laparoscopy; 3. presence of at least one of the following risk factors for the development of metachronous peritoneal metastases: * 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); 4. age \> 18; 5. performance status 2 according to the world health organization score; 6. willingness to start adjuvant systemic chemotherapy and post-operative follow-up; 7. signing of informed consent. exclusion criteria: 1. active sepsis; 2. cardiac function impairment (history of previous heart failure or 40% ejection fraction); 3. renal impairment (serum creatinine \>1.5 normal value or creatinine clearance 60 ml/min); 4. liver function impairment (aspartate aminotransferase, alanine aminotransferase, bilirubin \> 1.5 normal value); 5. bone marrow function impairment (leukocytes 4000 / mm3, neutrophils 1500 /mm3, platelets 80000/mm3); 6. lung function impairment (diagnosis of severe chronic obstructive pulmonary disease or 50% forced expiratory volume at one second or 40% diffusion capacity of lung for carbon monoxide adjusted for age); 7. extra-abdominal and/or hepatic metastases at the computed tomography scan of the chest, abdomen and pelvis with intravenous contrast; 8. severe complications (grade 3-4) after primary cancer surgery; 9. haemorrhagic diathesis or coagulopathy; 10. pregnancy or lactation in progress; 11. psychiatric or neurological conditions such as to preclude protocol procedures; 12) contraindications to laparoscopy; 13) known hypersensitivity to oxaliplatin or other platinum containing compounds and/or to any of their excipients; 14) history of previous malignancies treated in the last three years, excluding cutaneous spinocellular carcinoma and/or basocellular carcinoma; 15) prior pre-operative radio-chemotherapy..