Tests aerosol chemotherapy after surgery for high-risk colon cancer
Tests delivering chemotherapy as an aerosol into the abdomen in adults with colon cancer.
Plain-language title generated from the registry record
Registry title: Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
Key facts
- Where
- Odense C, DenmarkSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
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 whose colon cancer was fully removed by surgery but who have a high risk of the cancer coming back in the abdomen. They would get two PIPAC treatments with oxaliplatin.
- Age
- Older than 18 years
- Sex
- All sexes can join.
- Disease stage
- Colon cancer (adenocarcinoma or signet ring cell carcinoma) fully removed by surgery, with high-risk features: perforated tumor, pT4NanyM0, or pTanyNanyM1 with fully removed peritoneal metastases including ovarian metastases.
- Earlier treatment
- Surgery to remove the colon cancer, and standard adjuvant chemotherapy if it was indicated. Earlier cytoreductive surgery with HIPEC is not allowed.
Main reasons for not taking part
- Proven relapse on scans or by examination
- Another cancer diagnosis within the last 2 years
- Reasons that make keyhole surgery (laparoscopy) unsafe, such as severe adhesions or peritonitis
- Allergic reaction to oxaliplatin or other platinum drugs
- Poor kidney, heart, liver or blood counts as defined in the record
Read by machine on 9 November 2026.
Where in Denmark
- Odense University HospitalOdense C, DenmarkNo longer taking part
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
- Michael Bau Mortensen
- Trial code
- NCT03280511EU 2024-519189-31-00
- Record updated
- 6 October 2022
- Original description
In this study, patients will be offered two Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) treatments with oxaliplatin after primary resection and standard adjuvant chemotherapy (if indicated) for colon cancer. Furthermore, the study will explore, whether it is possible to find free intraperitoneal tumor cells (FITC) after resection and adjuvant chemotherapy for colon cancer.Read full original descriptionShow less
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial
In this study, patients will be offered two Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) treatments with oxaliplatin after primary resection and standard adjuvant chemotherapy (if indicated) for colon cancer. Furthermore, the study will explore, whether it is possible to find free intraperitoneal tumor cells (FITC) after resection and adjuvant chemotherapy for colon cancer.
Inclusion: Radically resected colon cancer patients with adeno- or signet ring cell carcinomas with high-risk tumors defined as: perforated / pT4NanyM0 (UICC 8th edition) / pTanyNanyM1 with radically resected PM including ovarian metastases; Performance status 0-1; Fertile women must use approved contraceptives (see below); Age > 18 years; Written informed consent.
Exclusion: Previous cytoreductive surgery (CRS) with HIPEC; Other malignant diagnosis within the last 2 years; A history of allergic reaction to oxaliplatin or other platinum containing compounds; Myocardial insufficiency, defined as NYHA class > 2; Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives; Renal impairment, defined as GFR < 50 ml/min, (Cockcroft-Gault Equation); Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit); Inadequate haematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l; Radiologically or clinically proven relapse; Contraindications to laparoscopy (e.g. severe adhesions, peritonitis).