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Taking people in ItalyPhase 2

Tests pressurized chemotherapy spray to prevent colorectal cancer spread in the belly

Tests a chemotherapy spray in the belly after surgery in adults with high-risk colorectal cancer.

Key facts

Who runs it
Fondazione IRCCS Istituto Nazionale Dei Tumori
Where
Milan, ItalySee the site
Registry title
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.
Status
Recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
24 Nov 2020
Planned end
29 May 2026
Type of study
Interventional
Record updated
23 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

  • Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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.
Plain-language title
Tests pressurized chemotherapy spray to prevent colorectal cancer spread in the bellyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
23 September 2026