Phase II study of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer.
Key facts
- Where
- Milan, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Trial code
- EU 2024-513376-17-00
- Record updated
- 2026. szeptember 23.
- Original description
Primary Objective of this study is to demonstrate the effectiveness of adjuvant PIPAC performed within 4-8 weeks after curative-intent surgery, and followed by adjuvant s-CT, in preventing the onset of PM in high risk colon cancer.Read full original descriptionShow less
Primary Objective of this study is to demonstrate the effectiveness of adjuvant PIPAC performed within 4-8 weeks after curative-intent surgery, and followed by adjuvant s-CT, in preventing the onset of PM in high risk colon cancer.
Inclusion: Histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection); Curative (microscopically complete) surgery performed by laparotomy or laparoscopy; 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); age >18; performance status 2 according to the WHO score; willingness to start adjuvant s-CT and post-operative follow-up; Signing of informed consent.
Exclusion: spinocellular carcinoma and/or basocellular carcinoma; prior pre-operative radio-chemotherapy; psychiatric or neurological conditions such as to preclude protocol procedures; known hypersensitivity to oxaliplatin or other platinum containing compounds and/or to any of their excipients; history of previous malignancies treated in the last three years, excluding cutaneous; severe complications (grade 3-4) after primary cancer surgery; 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); liver function impairment (AST, ALT, bilirubin > 1.5 normal value); bone marrow function impairment (leukocytes 4000 / mm3, neutrophils 1500 /mm3, platelets 80000/mm3); renal impairment (serum creatinine >1.5 normal value or creatinine clearance 60 ml/min); lung function impairment (diagnosis of severe COPD or 50% FEV1 or 40% DLCO adjusted for age); active sepsis; pregnancy or lactation in progress; contraindications to laparoscopy; extra-abdominal and/or hepatic metastases at the CT scan of the chest, abdomen and pelvis with intravenous contrast; haemorrhagic diathesis or coagulopathy.