Study on Irinotecan and mFOLFOX4-Bevacizumab for Patients with Resectable Colorectal Peritoneal Metastases

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What is this study about?

This clinical trial is focused on studying a treatment for patients with colorectal cancer that has spread to the lining of the abdomen, known as peritoneal metastases. The study involves a combination of medications, including irinotecan, oxaliplatin, folinic acid, fluorouracil, and bevacizumab. These medications are used as part of a chemotherapy regimen to treat the cancer. The purpose of the study is to determine if this combination of treatments is feasible before patients undergo a surgical procedure called CRS-HIPEC, which stands for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

Participants in the study will receive the chemotherapy drugs through an infusion, which means the medication is delivered directly into the bloodstream or the abdominal cavity. The treatment will be given over several cycles, with each cycle lasting a few weeks. The study will monitor how well patients tolerate the treatment and whether they can complete all the planned cycles of chemotherapy before undergoing the CRS-HIPEC procedure. The study will also assess the response of the cancer to the treatment using imaging tests and other evaluations.

The trial aims to gather information on the safety and effectiveness of this treatment approach for patients with colorectal cancer that has spread to the peritoneum. It will also look at the impact of the treatment on patients’ quality of life and their ability to remain free of disease after the surgery. The study is expected to continue for several years, with follow-up assessments to track the long-term outcomes for participants.

1 initial treatment phase

Upon joining the clinical trial, you will begin the initial treatment phase. This involves receiving a combination of medications through an intravenous (IV) line. The medications include oxaliplatin, folinic acid, fluorouracil, and bevacizumab. These are administered as a solution for infusion, which means they are given directly into your bloodstream through a vein.

During this phase, you will also receive irinotecan through intraperitoneal use, which means it is delivered directly into the abdominal cavity. The dosage for irinotecan is 75 mg. This phase is designed to prepare your body for the next steps in the treatment process.

2 subsequent treatment cycles

Following the initial treatment, you will undergo two additional cycles of the same combination of medications. These cycles involve the same intravenous administration of mFOLFOX4 (a combination of oxaliplatin, folinic acid, and fluorouracil) and bevacizumab, along with intraperitoneal irinotecan.

Each cycle is carefully monitored to assess your response to the treatment and to manage any side effects that may occur. The goal is to ensure that your body is responding well to the therapy before proceeding to the next stage.

3 preparation for surgery

After completing the chemotherapy cycles, you will be evaluated to determine your readiness for a surgical procedure known as CRS-HIPEC. This stands for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

The evaluation will include various tests and assessments to ensure that you are in optimal condition for the surgery. This step is crucial for maximizing the potential benefits of the treatment.

4 surgical procedure

If you are deemed ready, you will undergo the CRS-HIPEC procedure. This surgery aims to remove any remaining cancerous tissue in the abdominal cavity and is followed by the direct application of heated chemotherapy to the area.

The procedure is designed to target cancer cells more effectively and improve the chances of a successful outcome. Recovery from the surgery will be closely monitored by the medical team.

5 follow-up and monitoring

After the surgical procedure, you will enter a follow-up phase where your health and recovery are closely monitored. This includes regular check-ups and assessments to track your progress and address any concerns.

The follow-up period is essential for ensuring that you are recovering well and to evaluate the long-term effectiveness of the treatment. Your quality of life and any changes in your condition will be assessed during this time.

Who Can Join the Study?

Patients must have colorectal peritoneal metastases with a PCI-score (a score that measures the extent of cancer in the abdomen) between 1 and 20.
The colorectal cancer must be confirmed by a histological test (a test that examines tissues under a microscope).
The cancer must be a non-appendiceal adenocarcinoma (a type of cancer that starts in glandular cells) with peritoneal metastases (cancer spread to the lining of the abdomen), confirmed by pathology or imaging tests.
The peritoneal metastases can be synchronous (occurring at the same time as the primary tumor) or metachronous (occurring at a different time).
Visible peritoneal metastases must still be present at the time of joining the study or during a diagnostic procedure called laparoscopy (a surgery using small incisions and a camera).
The peritoneal cancer index (PCI) score must be between 1 and 20, indicating macroscopic (visible) disease.
There should be no systemic metastases (cancer spread to other parts of the body) at the time of joining the study.
Patients must have a WHO-performance score (a score that measures the patient’s ability to perform daily activities) of 0 to 1, and a life expectancy of at least three months.
Patients must be over 18 years old.
Patients must provide written informed consent (agreement to participate after understanding the study).

Who Cannot Join the Study?

Patients with a PCI-score higher than 20 cannot participate. The PCI-score is a way to measure how much cancer has spread in the abdomen.
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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Netherlands Cancer Institute	Amsterdam	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Aerbcwkmh Uxy	Amsterdam	The Netherlands
Ezcofmr Ucvylytfzmhi Myvlzlh Ckovjdb Rgamvkahx (vwndhqt Mlx	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.10.2024

Trial locations

Investigated drugs:

Irinotecan is a type of chemotherapy drug used to treat cancer. In this trial, it is given directly into the abdominal area, which is called intraperitoneal administration. This method helps to target cancer cells in the abdomen more effectively. Irinotecan works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

mFOLFOX4 is a combination of chemotherapy drugs used to treat colorectal cancer. It includes several medications that work together to stop cancer cells from growing. This combination is given through an intravenous infusion, which means it is delivered directly into the bloodstream. The goal is to reduce the size of the cancer and prevent it from spreading.

Bevacizumab is a medication that helps to stop the growth of new blood vessels that tumors need to grow. It is given through an intravenous infusion. By blocking the blood supply to the tumor, bevacizumab can help to slow down or stop the growth of cancer.

Investigated diseases:

Colorectal Cancer with Peritoneal Metastases – Colorectal cancer with peritoneal metastases occurs when cancer cells from the colon or rectum spread to the peritoneum, the lining of the abdominal cavity. This spread is often a result of cancer cells detaching from the primary tumor and traveling through the bloodstream or lymphatic system. The disease progresses as these metastatic cells implant and grow on the peritoneal surfaces, forming new tumor sites. Over time, these tumors can cause the peritoneum to thicken and lead to the accumulation of fluid in the abdominal cavity, known as ascites. As the disease advances, it can interfere with the function of abdominal organs, leading to symptoms such as abdominal pain, bloating, and changes in bowel habits. The progression of the disease can vary depending on factors like the extent of metastasis and the biological characteristics of the cancer cells.

Trial ID:

2024-512318-16-00

Protocol code:

2024-512318-16-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Irinotecan and mFOLFOX4-Bevacizumab for Patients with Resectable Colorectal Peritoneal Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?