Study on Oxaliplatin with Drug Combination for Patients with Advanced Peritoneal Metastasis from Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for patients with advanced peritoneal metastasis from colorectal cancer. The study aims to evaluate the effectiveness of combining systemic treatments, which include chemotherapy and targeted therapy, with a method called pressurized intraperitoneal aerosol chemotherapy (PIPAC), compared to using systemic treatment alone. The goal is to see if this combination can improve the time patients live without the cancer getting worse.

The treatments being studied include several medications. Capecitabine is a chemotherapy drug taken orally in the form of a film-coated tablet. Panitumumab and cetuximab are targeted therapies given through intravenous infusion, which means they are administered directly into a vein. Bevacizumab, also known by code names like BI 695502, is another targeted therapy given by infusion. Fluorouracil and irinotecan hydrochloride trihydrate are chemotherapy drugs administered through infusion. Oxaliplatin is a chemotherapy drug that will be used in a unique way in this study, delivered directly into the abdominal cavity using a special device called the Capnopen CP-001k.

Participants in the study will receive either the combination of systemic treatments and PIPAC or systemic treatments alone. The study will monitor the progression of the disease and overall survival, as well as any side effects related to the treatments. The trial is expected to continue for several years, with regular assessments to track the effectiveness and safety of the treatments.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the details of the study.

You will need to confirm that you meet the eligibility criteria, such as being 18 years or older and having a specific medical condition related to colorectal cancer.

2 initial assessments

You will undergo initial assessments to evaluate your health status. This includes blood tests to check your creatinine clearance, neutrophil count, and other important health indicators.

A surgical exploration may be required if not performed within the last four weeks to assess the extent of your condition.

3 randomization

You will be randomly assigned to one of two groups: one receiving systemic treatment alone, and the other receiving systemic treatment combined with a procedure called PIPAC (pressurized intraperitoneal aerosol chemotherapy).

4 treatment phase

If you are in the systemic treatment group, you will receive medications such as capecitabine (oral use), panitumumab, bevacizumab, fluorouracil, irinotecan hydrochloride trihydrate, cetuximab, and oxaliplatin (all administered intravenously).

The dosage, frequency, and duration of these medications will be determined by the study protocol and your healthcare provider.

5 PIPAC procedure

If you are in the group receiving PIPAC, this procedure will be performed in addition to the systemic treatment. PIPAC involves delivering chemotherapy directly into the abdominal cavity using a minimally invasive technique.

6 follow-up visits

You will have regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and possibly imaging studies.

You will be asked to complete questionnaires about your quality of life and any side effects you may experience.

7 end of treatment

At the end of the treatment phase, your progress will be evaluated to determine the effectiveness of the treatment.

You will continue to be monitored for any long-term effects or recurrence of your condition.

Who Can Join the Study?

Age must be 18 years or older.
Must agree to use effective birth control during the treatment and for at least 9 months after the last dose if of childbearing age.
Kidney function must be adequate, with a creatinine clearance of at least 30 mL/min. This is a measure of how well your kidneys are working.
No known risk of toxicity from a drug called irinotecan.
No deficiency in an enzyme called Dihydropyrimidine dehydrogenase, which is checked by a blood test.
Must be willing and able to follow the study rules, including attending all treatment sessions and follow-up visits.
Must have valid health insurance.
Must provide written informed consent before any study procedures begin.
Must have an ECOG performance status of 0 to 2. This is a scale that measures your ability to perform daily activities.
Must have a confirmed diagnosis of colon cancer with peritoneal metastasis, which means the cancer has spread to the lining of the abdomen.
The cancer must be considered unresectable, meaning it cannot be removed by surgery, based on specific medical criteria.
Must have had a surgical exploration within 4 weeks before joining the study. If not, a minimally invasive surgery called laparoscopy must be performed.
Must be receiving first-line systemic chemotherapy for advanced or metastatic colon cancer. Previous chemotherapy is allowed if it was completed more than 6 months before the cancer returned and there is no ongoing nerve damage from a drug called oxaliplatin.
No extensive internal abdominal adhesions, which are bands of scar tissue, confirmed by surgical exploration.
Blood tests must show adequate levels of neutrophils (a type of white blood cell), platelets (cells that help with blood clotting), and hemoglobin (a protein in red blood cells). Liver and kidney function tests must also be within acceptable limits.

Who Cannot Join the Study?

Patients who do not have advanced peritoneal metastasis from colorectal cancer. Peritoneal metastasis means that the cancer has spread to the lining of the abdomen.
Patients with a Peritoneal Cancer Index (PCI) of 15 or less. The PCI is a score that helps to measure the extent of cancer 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?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Nouvel Hopital Civil Strasbourg	STRASBOURG, Alsace	France
Centre Hospitalier Tarbes-Lourdes	Tarbes	France
Iqfghdlb Rvdurxjg Dn Citxdy Dr Mtnubzctmbv	Montpellier	France
Chdsjb Hgfqpmrqqwo Eb Upvrfzsjykshy Dh Lmaapse	Limoges	France
Ayklghzyxc Pxrkznfr Hwvbjhje Dw Mimhjrdhl	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Systemic Chemotherapy is a treatment that uses drugs to kill cancer cells throughout the body. In this trial, it is used to treat patients with advanced colon cancer that has spread to the lining of the abdomen. The goal is to stop the cancer from growing and spreading further.

Targeted Therapy involves using drugs that specifically target cancer cells, often by interfering with specific molecules involved in the growth and spread of cancer. This therapy aims to attack cancer cells more precisely, causing less harm to normal cells compared to traditional chemotherapy.

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) is a newer method of delivering chemotherapy directly into the abdomen. It involves spraying a fine mist of chemotherapy drugs inside the abdominal cavity under pressure. This approach aims to enhance the effectiveness of the drugs by allowing them to reach cancer cells more directly and in higher concentrations.

Investigated diseases:

Colorectal cancer

Peritoneal Metastasis from Colorectal Cancer – Peritoneal metastasis from colorectal cancer occurs when cancer cells from the colon or rectum spread to the peritoneum, the lining of the abdominal cavity. This condition is characterized by the growth of cancerous tumors on the peritoneal surface. As the disease progresses, it can lead to the accumulation of fluid in the abdomen, known as ascites, and cause abdominal pain or discomfort. The spread of cancer to the peritoneum can also result in bowel obstruction, which may cause nausea, vomiting, and changes in bowel habits. Over time, the tumors may grow larger and more numerous, potentially affecting the function of nearby organs. The progression of peritoneal metastasis can vary, with some patients experiencing rapid advancement while others may have a slower disease course.

Trial ID:

2024-514560-10-00

Protocol code:

ICO-2023-14

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Oxaliplatin with Drug Combination for Patients with Advanced Peritoneal Metastasis from Colorectal Cancer

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