2024-513376-17-00RecruitingPhase 2
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 23 Apr 2024
- Start date
- 24 Nov 2020
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Diseases
- Colorectal cancer
- EU CT number
- 2024-513376-17-00
- EudraCT number
- 2020-000604-11
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had surgery to remove all of a high-risk colon cancer. It tests an extra chemotherapy given into the belly to prevent cancer spread in the abdominal lining.
- Age
- Over 18 years
- Sex
- Men and women
- Disease stage
- Colon cancer (intestinal type, mucinous or signet ring cell) with complete removal by surgery. The tumour must have perforated, grown into the lining of the abdomen, or grown into nearby organs. No spread to the liver or outside the abdomen.
- Earlier treatment
- Must have had surgery that removed all of the tumour (seen under the microscope). Must be willing to start chemotherapy after surgery. Cannot have had radio-chemotherapy before the operation.
Main reasons for not taking part
- Active serious infection (sepsis)
- Pregnancy or breastfeeding
- Other cancer treated in the last three years (some skin cancers excepted)
- Weak heart, kidney, liver, bone marrow or lung function
- Serious complications after the cancer surgery, or bleeding or clotting disorder
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- spinocellular carcinoma and/or basocellular carcinoma; prior pre-operative radio-chemotherapy.
Other illness
- 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;
Lab values
- 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)
Age
- lung function impairment (diagnosis of severe COPD or 50% FEV1 or 40% DLCO adjusted for age)
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.