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Study on Oxaliplatin for Reducing Recurrence Risk in High-Risk Colon Cancer Patients After Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying colon cancer, a type of cancer that affects the large intestine. The treatment being tested is called Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC), which involves delivering chemotherapy directly into the abdominal cavity in a pressurized aerosol form. The main goal of the study is to see if PIPAC can reduce the risk of cancer returning in patients who have had high-risk colon cancer surgically removed.

Participants in the study will receive the chemotherapy drug oxaliplatin through a method known as intraperitoneal use, meaning it is administered directly into the abdominal area. The study will involve two treatments with PIPAC, and researchers will monitor patients over time to check for any recurrence of cancer using imaging techniques like computed tomography (CT) scans. The study will also look at the safety of the treatment and any side effects that may occur.

The trial aims to follow patients for several years to gather information on how well the treatment works in preventing the return of cancer and to assess overall survival rates. This research could provide valuable insights into new ways to manage high-risk colon cancer after surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on specific criteria. These include having had colon cancer surgically removed, being over 18 years old, and having a good general health status.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information. This may involve physical examinations and imaging tests such as CT scans of the chest and abdomen.

  3. Step 3

    First PIPAC treatment

    The first treatment involves Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC). This procedure administers the chemotherapy drug oxaliplatin directly into the abdominal cavity in aerosol form. The exact dosage and frequency are determined by the medical team.

  4. Step 4

    Monitoring and follow-up

    After the first treatment, regular monitoring is conducted to assess health status and any side effects. This includes follow-up visits and possibly additional imaging tests.

  5. Step 5

    Second PIPAC treatment

    A second PIPAC treatment is scheduled. The procedure is similar to the first, with the aim of reducing the risk of cancer recurrence.

  6. Step 6

    Long-term follow-up

    Long-term follow-up is conducted over several years. This includes regular check-ups and imaging tests to monitor for any signs of cancer recurrence. The primary goal is to evaluate the effectiveness of the treatment in preventing cancer from returning.

Who can join the trial?

5 criteria

  • Patients must have had their colon cancer completely removed through surgery.
  • The type of cancer must be either adenocarcinoma or signet ring cell carcinoma. These are specific types of cancer that start in glandular cells.
  • The cancer must be considered high-risk, which means it has certain characteristics like being perforated or having spread to nearby tissues or lymph nodes but not to distant organs.
  • Patients must have a performance status of 0-1. This is a measure of how well a person can perform ordinary tasks and carry out daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
  • Patients must be older than 18 years.

Who cannot join the trial?

3 criteria

  • Patients who have not been diagnosed with colon cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is a treatment method used in this clinical trial. It involves delivering chemotherapy directly into the abdominal cavity in the form of a pressurized aerosol. This approach aims to target cancer cells more effectively by allowing the medication to reach areas that might be difficult to treat with traditional methods. In this trial, PIPAC is being tested to see if it can reduce the risk of cancer returning in patients who have had surgery for high-risk colon cancer.

What is already known about the treatment

Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) – PIPAC is a method of administering chemotherapy directly into the abdominal cavity using a pressurized aerosol spray. This innovative approach is currently being studied in clinical trials for its potential to reduce the recurrence of peritoneal metastasis in patients with high-risk colon cancer who have undergone surgery. The main therapeutic indication for PIPAC is to target cancer cells in the peritoneal area, aiming to prevent their return. At the molecular level, PIPAC delivers chemotherapy drugs directly to the affected area, enhancing their effectiveness by increasing local drug concentration while minimizing systemic exposure. It is classified as a form of regional chemotherapy, specifically designed for treating cancers within the abdominal cavity.

Investigated diseases

Colon cancer – Colon cancer is a type of cancer that begins in the large intestine, which is the final part of the digestive tract. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease progresses, cancer cells can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colon cancer can lead to symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort. The disease can advance through various stages, from localized growths to widespread metastasis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519189-31-00Protocol codePIPACOPC3CCEstimated enrolment60 patientsSponsorOdense University Hospital

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