Recruiting

Study of Hyperthermic Intraperitoneal Chemotherapy with Irinotecan and Fluorouracil in Patients with Colorectal Cancer

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What is this trial about?

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

This clinical trial focuses on treating patients with colorectal cancer that has spread to the lining of the abdomen. The study tests a combination of two anti-cancer medications: irinotecan and fluorouracil (also known as 5-FU). These medications are given through special infusion techniques directly into the abdominal cavity.

The study consists of two parts. The first part aims to find the safest and most effective dose of fluorouracil when combined with irinotecan. The second part will evaluate how well this treatment works in preventing the cancer from returning. Both medications are delivered through a procedure where the drugs are heated and circulated within the abdominal cavity during surgery.

During the treatment, patients receive intraperitoneal chemotherapy, which means the anti-cancer drugs are delivered directly into the abdominal cavity. The medications are given at specific doses - irinotecan up to 270 mg per square meter of body surface area, and fluorouracil up to 640 mg per square meter of body surface area. Patients will be monitored for up to five years to assess how well the treatment works and any side effects that may occur.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
Your doctor will perform laboratory tests to check your kidney, liver, and bone marrow function
If you are a woman who can become pregnant, you will need to take a pregnancy test
Your overall physical condition will be evaluated using a special scale called ECOG Performance Status or Karnofsky score
Step 2
Phase I treatment
You will receive a combination of medications through infusion:
- Irinotecan and oxaliplatin during a procedure called HIPEC (heated chemotherapy delivered directly to the abdominal cavity)
- Fluorouracil (5-FU) as a 24-hour infusion after the HIPEC procedure
Doctors will monitor your response to determine the best dose of medications
Your condition will be monitored for 30 days after treatment to check for any side effects
Step 3
Phase III treatment
You will be monitored for cancer recurrence for 24 months
Regular examinations will check for any signs of cancer in the abdominal cavity or liver
Your quality of life will be evaluated for up to 3 years after treatment
Follow-up visits will continue for up to 5 years to track your overall health and survival
Step 4
Monitoring and evaluation
Your recovery will be monitored for complications during the first 30 days after treatment
Regular check-ups will continue throughout the study period until December 2029
Your medical team will track any side effects or health changes during the entire study period

Who can join the trial?

13 criteria

Must provide written consent before any study procedures begin
Must have a performance status of either:
- ECOG Score of 0-2 (measure of patient's ability to care for themselves) or
- Karnofsky Score of 60-100 (scale measuring patient's general well-being)
- Must have normal function of:
  - Kidneys
  - Liver
  - Bone marrow
  - Women who can become pregnant must have a negative pregnancy test
  - Age between 18 and 78 years old
  - Must have colorectal cancer that has spread to:
    
    The lining of the abdomen (peritoneal metastases)
    May also have cancer spread to the liver
    May have cancer that has spread to the lungs that can be surgically removed
    Must be suitable for:
    
    CRS (surgery to remove visible tumors)
    HIPEC (heated chemotherapy treatment delivered to the abdomen during surgery)

Who cannot join the trial?

15 criteria

Age under 18 or over 65 years old
Pregnant or breastfeeding women
History of severe allergic reactions to oxaliplatin or irinotecan (chemotherapy medications)
Active infection or fever above 38°C (100.4°F)
Severe heart conditions including uncontrolled high blood pressure or recent heart attack
Severe kidney problems (impaired renal function)
Severe liver problems (impaired liver function)
Active bleeding disorders
Previous extensive abdominal surgery that would interfere with the procedure
Mental conditions that prevent understanding of the consent process
Participation in other clinical trials within the past 30 days
Known spread of cancer to the brain or central nervous system
Severe bone marrow problems affecting blood cell counts
Uncontrolled diabetes
Body Mass Index (BMI) above 35

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Karolinska University Hospital
Solna, Sweden
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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden
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Region Skane Skanes Universitetssjukhus
Lund, Sweden

Trial locations

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Investigated drugs

Oxaliplatin
A chemotherapy medication used to treat colorectal cancer. It works by damaging cancer cells' DNA, which prevents them from dividing and growing. This medication is administered through heated chemotherapy directly into the abdominal cavity (HIPEC procedure).
Irinotecan
A chemotherapy drug that treats colorectal cancer by stopping cancer cells from growing and dividing. Like oxaliplatin, it is given through heated chemotherapy directly into the abdominal cavity (HIPEC procedure).
5-Fluorouracil
A widely used chemotherapy medication that works by interfering with cancer cell growth. In this trial, it is given as a continuous treatment over 24 hours after the main procedure (EPIC - Early Postoperative Intraperitoneal Chemotherapy).

What is already known about the treatment

5-Fluorouracil
A chemotherapy medication administered intravenously or as a topical cream, widely used in cancer treatment since the 1950s. This antimetabolite drug works by interfering with DNA and RNA synthesis in cancer cells, preventing their growth and multiplication, and is primarily used in treating colorectal cancer, breast cancer, and other solid tumors. It belongs to the fluoropyrimidine class of medications and acts by blocking the enzyme thymidylate synthase, which is essential for cancer cell division.
Oxaliplatin
An intravenously administered platinum-based chemotherapy drug commonly used in combination therapy for colorectal cancer. This medication works by forming cross-links in DNA, preventing cancer cells from dividing and growing, and is often used alongside other chemotherapy drugs for enhanced effectiveness. It belongs to the platinum-containing compounds class and has become a standard component in colorectal cancer treatment protocols since its introduction in the late 1990s.
Irinotecan
An intravenous chemotherapy medication that belongs to the topoisomerase inhibitor class of drugs. It works by interfering with enzymes responsible for DNA replication in cancer cells, effectively stopping their growth and division, and is primarily used in the treatment of colorectal cancer, often in combination with other chemotherapy agents. The drug has been an important component of colorectal cancer treatment since its approval in the 1990s.

Investigated diseases

Colorectal cancer - A disease that begins in either the colon or rectum, which are parts of the large intestine. It typically starts as small, benign clumps of cells called polyps that form on the inner lining of the colon or rectum. Over time, some of these polyps can develop into cancer. The disease usually develops slowly, often taking several years to progress from early to advanced stages. As the condition progresses, cancer cells can grow through the walls of the colon or rectum and potentially spread to other parts of the body.