AuthorisedTherapeutic exploratory (Phase II)Interventional

Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases – a phase II study

This research study is for people with bowel cancer that has spread to the inner lining of their abdomen (peritoneum) and cannot be operated on. It's looking at a new treatment approach that adds a chemotherapy drug, irinotecan, given directly into the tummy space. This is done alongside standard chemotherapy and another drug called bevacizumab, which are given into a vein. The main aim is to find out if this combination helps people live longer by slowing down the cancer's growth. Researchers will carefully track how long patients live from when their peritoneal cancer was diagnosed, and from when they started the trial treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Catharina Ziekenhuis Stichting

Enrolment target

Start

03 Sep 2024

Irresectable peritoneal metastases of colorectal cancer

What is this study about?

This study is designed for individuals who have bowel cancer which has spread to the lining of their tummy (abdomen), known as peritoneal metastases. For these patients, surgery to remove the cancer isn't an option. The research is exploring a new way to deliver treatment that involves giving a chemotherapy drug called irinotecan directly into the tummy. This is done in combination with other standard cancer treatments given through a drip into a vein. The hope is that by delivering the chemotherapy directly to where the cancer has spread, it might be more effective.

The main goal of this study is to see if this new treatment approach can help people live longer. The researchers will closely monitor how long patients live from the time they were first diagnosed with cancer in their tummy lining, and also from the day they start the new treatment in the study. This will help them understand the real impact of this combined treatment.

This is a Phase II study, which means it builds on earlier research and aims to confirm if the treatment is effective and safe enough to potentially be offered more widely in the future. It's a key step in exploring better treatment options for this type of advanced bowel cancer.

Key takeaways

This study is for advanced bowel cancer that has spread to the tummy lining.
It combines standard treatments with chemotherapy given directly into the tummy.
The main goal is to see if this new approach helps people live longer.
It's a Phase II study, exploring effectiveness and safety.
You would receive regular treatments and check-ups at the hospital.

Who may be eligible?

This study is open to both men and women. To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to participate if they meet other health requirements.

More detailed eligibility criteria, such as your specific health condition, previous treatments, and certain blood test results, would be discussed fully with your doctor and the study team. These criteria are put in place to ensure the study is safe for you and that the results are as clear as possible.

Quick self-check

Are you 18 years old or older?
Do you have bowel cancer that has spread to the lining of your tummy?
Has your doctor told you that surgery to remove the cancer is not possible?
Are you comfortable considering receiving chemotherapy directly into your tummy?
Are you generally well enough to participate in a clinical study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would receive the new combination treatment, which involves chemotherapy. A key part of this new treatment is receiving one of the chemotherapy drugs, irinotecan, directly into your tummy space. This is typically done through a special tube or port that would be placed in your abdomen. You would also receive standard chemotherapy drugs and another medicine through a drip in your arm.

Throughout the study, you would have regular hospital visits for your treatments, doctor check-ups, and various tests such as blood tests and scans. These are important for monitoring your health, how you are responding to the treatment, and detecting any side effects. The total duration of your participation would depend on how your body responds to the treatment.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment approach for your condition that is not yet widely available. It could potentially help to slow down your cancer and improve your quality of life. However, like all medical treatments, there are potential risks and side effects associated with chemotherapy and the specific drugs used in this study. The study team will explain these thoroughly, including potential side effects from the chemotherapy given into your tummy. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

—
Netherlands

Common questions

What kind of cancer is this study for?

This study is for people who have bowel cancer that has spread to the lining of their tummy and cannot be removed by surgery.

What is 'intraperitoneal irinotecan'?

It's a way of giving a chemotherapy drug called irinotecan directly into the space inside your tummy, where the cancer has spread.

Will I still receive my usual chemotherapy?

Yes, this new treatment is given alongside your standard chemotherapy and another drug, which you would receive through a drip in your arm.

What is a 'Phase II study'?

A Phase II study is a type of research that aims to see if a new treatment is effective and safe enough to potentially be used more widely in the future.

How long would I be in the study?

The length of your participation would depend on how your body responds to the treatment, with regular check-ups and monitoring.