Recruiting

Study on Preventing Peritoneal Metastases in High-Risk Colorectal Cancer Patients Using Fluorouracil, Oxaliplatin, and Levoleucovorin After Surgery

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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 the prevention of peritoneal metastases, which are cancerous growths in the lining of the abdomen, in patients who have undergone surgery for high-risk colorectal cancer. The study involves a treatment method called pressurized intraperitoneal aerosol chemotherapy (PIPAC), which is a way of delivering chemotherapy directly into the abdomen in a mist form. This treatment is given after surgery to help prevent the spread of cancer.

The medications used in this study include Fluorouracil, Oxaliplatin, and Levoleucovorin. These are common chemotherapy drugs that work by stopping the growth of cancer cells. The study aims to demonstrate the effectiveness of PIPAC when used within 4-8 weeks after surgery, followed by standard chemotherapy, in preventing the onset of peritoneal metastases in patients with high-risk colon cancer.

Participants in the study will receive the PIPAC treatment and then continue with additional chemotherapy as part of their post-operative care. The study will monitor the patients over a period to assess how well the treatment prevents the spread of cancer. The goal is to improve the survival rate without peritoneal metastases from the time of surgery to any potential diagnosis of metastases. This study is part of ongoing research to find better ways to treat and prevent the spread of colorectal cancer.

The research process

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

Step 1
Joining the study
Participation begins after signing an informed consent form. This confirms understanding and agreement to participate in the study.
Step 2
Surgery
A curative-intent surgery is performed to remove the colorectal cancer. This surgery is done either through a large incision (laparotomy) or small incisions (laparoscopy).
Step 3
Waiting period
A waiting period of 4 to 8 weeks follows the surgery. This allows for recovery before starting the next phase of treatment.
Step 4
PIPAC treatment
The next step involves a treatment called pressurized intraperitoneal aerosol chemotherapy (PIPAC). This is a method where chemotherapy drugs are delivered directly into the abdominal cavity as a spray. The goal is to prevent the spread of cancer to the lining of the abdomen.
Step 5
Adjuvant systemic chemotherapy
Following PIPAC, adjuvant systemic chemotherapy (s-CT) is administered. This involves the use of medications such as fluorouracil, oxaliplatin, and levoleucovorin. These are given as solutions for infusion, meaning they are delivered directly into the bloodstream through a vein.
The specific dosage and frequency of these medications are determined by the healthcare provider based on individual patient needs.
Step 6
Follow-up
Regular follow-up appointments are scheduled to monitor health and check for any signs of cancer returning. These appointments are important for assessing the effectiveness of the treatment and managing any side effects.

Who can join the trial?

8 criteria

The patient must have a confirmed diagnosis of a specific type of colon cancer, which includes intestinal type, mucinous, or signet ring cell adenocarcinoma. This means the cancer starts in the colon and has certain characteristics.
The patient must have had surgery to remove the cancer, and the surgery should have been successful in removing all visible cancer. This surgery can be done through a large cut in the belly (laparotomy) or through small cuts using a camera (laparoscopy).
The patient must have at least one risk factor for developing cancer in the lining of the belly (peritoneal metastasis). These risk factors include:
- A primary tumor that has burst (perforated).
- A primary tumor that has spread to the lining of the belly (visceral peritoneum) or to nearby organs.
- The patient must be older than 18 years.
- The patient must have a performance status of 2 according to the WHO score. This means the patient is up and about more than half of the day but may not be able to work.
- The patient must be willing to start additional treatment after surgery, known as adjuvant systemic chemotherapy (s-CT), and agree to regular check-ups after the surgery.
- The patient must agree to participate in the study by signing a document that explains the study and gives their permission, known as informed consent.

Who cannot join the trial?

5 criteria

Patients who have not had surgery with the intent to cure their colon cancer.
Patients who are not within 4-8 weeks after their surgery.
Patients who are not considered high risk for colon cancer.
Patients who are younger than 18 years old or older than 65 years old.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy

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Investigated drugs

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)
is a treatment method used in this study to prevent the spread of cancer to the lining of the abdomen after surgery for colorectal cancer. It involves delivering chemotherapy directly into the abdominal cavity in the form of a pressurized aerosol, which allows for better penetration of the medication into the tissues.
Adjuvant Systemic Chemotherapy (s-CT)
is a follow-up treatment given after the initial surgery and PIPAC. This therapy involves administering chemotherapy drugs through the bloodstream to target any remaining cancer cells throughout the body, helping to reduce the risk of cancer recurrence.

What is already known about the treatment

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) – This treatment is administered as an aerosol spray directly into the abdominal cavity, typically following surgery. It is currently being studied in clinical trials, particularly for its potential to prevent the spread of cancer to the peritoneum in patients with high-risk colorectal cancer. The main therapeutic indication is to prevent peritoneal metastases after surgery. PIPAC works by delivering chemotherapy directly to the site where cancer cells may spread, enhancing the drug's effectiveness while minimizing systemic exposure. It is classified under localized chemotherapy treatments.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, which are parts of the large intestine. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The progression of colorectal cancer can vary, but it often involves the cancer spreading through the wall of the colon or rectum and potentially to nearby lymph nodes or other organs. Symptoms may include changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss. Early stages may not present noticeable symptoms, making regular screenings important for detection.