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

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What is this study about?

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.

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

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

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

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 Study?

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
as shown by laboratory tests
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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Uxystgg Uawtbkxseh Husxnoiu	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	28.03.2021

Trial locations

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).

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.

Trial ID:

2024-516224-34-00

Protocol code:

EFFIPEC01

NCT ID:

NCT04861558

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?