AuthorisedTherapeutic exploratory (Phase II)Interventional

Neo-adjuvant intraperitoneal chemotherapy (irinotecan) and systemic chemotherapy (mFOLFOX4-bevacizumab) prior to CRS-HIPEC for patients with isolated resectable colorectal peritoneal metastases: a multicentre, phase II trial (INTERACT-PLUS)

This study is for people with bowel cancer that has spread to the lining of their tummy, called peritoneal metastases. Doctors are testing a new approach called 'neo-adjuvant' therapy, where a combination of powerful anti-cancer medicines is given before surgery. These medicines include a special type given directly into the tummy and others given through a drip. After these medicines, patients will have surgery to remove the cancer, followed by a heated chemotherapy wash inside the tummy. The main aim is to see how many patients can complete all parts of this treatment. Researchers also want to understand how well the treatment works, its side effects, and how it affects patients' quality of life.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

10 Oct 2024

Patients with colorectal peritoneal metastases with a PCI-score of 1-20

What is this study about?

This study is called INTERACT-PLUS and it's looking into new ways to treat a type of bowel cancer called colorectal cancer. Sometimes, this cancer can spread to the lining of the tummy, which is called peritoneal metastases. This can be a challenging condition to treat, and doctors are always looking for better options for patients.

In this study, doctors are trying a new treatment plan. Patients will first receive a combination of anti-cancer medicines. Some of these medicines are given as a drip into a vein, which is called 'systemic chemotherapy'. Another special medicine is given directly into the tummy area itself, which is called 'intraperitoneal chemotherapy'. The idea of giving these medicines *before* surgery is to try and shrink the cancer or make it easier to remove. After these initial treatments, patients will have an operation to remove the cancer, followed by a treatment where heated anti-cancer medicine is washed around inside the tummy, known as HIPEC.

The main goal of the study is to see how many patients can successfully go through all these stages of treatment. The researchers will also carefully check for any side effects of the medicines, how well the cancer responds to the treatment, and how patients' day-to-day lives and well-being are affected. This research aims to find out if this new approach can become a better way to treat colorectal peritoneal metastases in the future.

Key takeaways

Tests a new approach for bowel cancer spread to the tummy lining.
Combines special anti-cancer medicines given before surgery.
Includes surgery and a heated chemotherapy wash (HIPEC).
Aims to see how many patients can complete the full treatment.
Monitors side effects, cancer response, and quality of life.
Open to patients aged 18 and over.

Who may be eligible?

To join this study, you must be at least 18 years old, and the study is open to both men and women. The most important thing is that you have bowel cancer that has spread to the lining of your tummy (peritoneal metastases), and doctors believe it's possible to remove these cancer spots with surgery.

Your doctors will do some special tests to check how much the cancer has spread within your tummy area. There's a particular score they use, and for this study, your score needs to be between 1 and 20. This helps the medical team decide if this specific treatment approach is suitable for you.

There will be other medical checks to make sure you are generally well enough to receive the treatments involved, as they can be quite strong. Your doctor will discuss all the specific criteria with you to see if you might be a good fit for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have bowel cancer that has spread to the lining of your tummy (peritoneal metastases)?
Have your doctors determined that your cancer spread in the tummy is within a specific range (a PCI-score of 1-20)?
Are you generally well enough to undergo demanding treatments and surgery?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will first receive several cycles of anti-cancer medicines. Some will be given directly into your tummy, and others will be given through a drip into your vein. This period is expected to last for at least four cycles, with each cycle involving specific treatment days followed by rest days. During this time, you'll have regular hospital visits for your treatments and to have your health closely monitored with blood tests and scans.

After completing these initial treatments, if your doctors determine it's still appropriate, you will have surgery to remove the cancer. During this operation, you will also receive the heated chemotherapy wash (HIPEC) inside your tummy. Following surgery, you'll have a recovery period and then continue with follow-up appointments, including scans and assessments.

Researchers will regularly ask you to complete questionnaires about your quality of life and any symptoms you experience. The study will continue to monitor your health for at least six months after your surgery to see how you are doing long-term. The exact total duration for your participation will depend on your individual treatment plan and recovery.

Potential risks and benefits

Taking part in this study might offer a potential benefit by giving you access to a new treatment approach that combines medicines before surgery, which could improve how well the cancer is treated. However, all medical treatments, especially anti-cancer medicines and major surgery, come with potential risks and side effects. These could include feeling unwell, tiredness, hair loss, infection, changes in blood counts, and complications from surgery. The study team will carefully monitor you for any problems. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What kind of cancer is this study for?

This study is for people with bowel cancer (colorectal cancer) that has spread to the lining of their tummy (peritoneal metastases).

What does 'neo-adjuvant' mean?

'Neo-adjuvant' means that the anti-cancer medicines are given *before* surgery to try and shrink the cancer or make the surgery more effective.

What is HIPEC?

HIPEC stands for Heated Intraperitoneal Chemotherapy. It's a treatment where heated anti-cancer medicine is washed inside your tummy during surgery.

Will I have to travel for treatments?

This is a 'multicentre' study, meaning it takes place in several hospitals. Your doctor will tell you where your treatments and appointments will be held.

What is the main thing the study wants to find out?

The main goal is to see how many patients can successfully complete all parts of the planned treatment – the medicines before surgery, the surgery itself, and the HIPEC.