AuthorisedTherapeutic confirmatory (Phase III)Interventional

Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases in patients with a low clinical risk score – a randomized controlled trial

This research trial is studying a specific type of chemotherapy called hepatic arterial infusion pump (HAIP) chemotherapy. This treatment delivers chemotherapy medicine directly into the liver after surgery to remove bowel cancer that has spread there. The main goal is to find out if this treatment helps people live longer without their cancer returning, especially those who are considered to have a lower risk of their cancer spreading further. Researchers will also look at how long people live overall, if the cancer comes back in the liver, any side effects, how the treatment affects quality of life, and its cost-effectiveness. This is a Phase 3 study, meaning it's comparing a new treatment to standard care to confirm its benefits.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

230

Start

08 Oct 2024

Resectable colorectal rectal metastases without extrahepatic disease

What is this study about?

This study is for people who have had surgery to remove bowel cancer that has spread to their liver. Doctors call this 'colorectal liver metastases' (colorectal means bowel, and metastases means the cancer has spread). The trial is investigating a special way of giving chemotherapy directly to the liver, using a small pump. This is called hepatic arterial infusion pump (HAIP) chemotherapy. The idea behind this treatment is to deliver a high dose of chemotherapy medicine directly to the cancer cells in the liver, while potentially reducing side effects to the rest of the body.

The main question the researchers want to answer is whether this special chemotherapy, given after surgery, can help people stay cancer-free for longer. They are particularly focusing on people who have a lower chance of their cancer spreading again, according to certain medical assessments. This is a 'randomised controlled trial', which means some people will receive the new treatment and others will receive standard care, to compare the results fairly.

The study will also look at other important things. This includes how long people live overall, whether the cancer returns specifically in the liver, and any problems or side effects people might experience (such as infections or other common reactions to chemotherapy). They will also consider how the treatment affects a person's general well-being and quality of life, and whether it is a good use of NHS resources. By studying these different aspects, doctors hope to understand if this treatment could become a new, effective option for people in the future.

Key takeaways

This study investigates a targeted chemotherapy delivery directly to the liver after bowel cancer surgery.
It aims to see if this treatment helps people live longer without their cancer returning.
Specifically focuses on patients with bowel cancer that has spread only to the liver, and who are deemed lower risk.
It's a Phase 3 study, meaning it's comparing a new treatment to standard care.
Researchers will assess effectiveness, safety, quality of life, and cost.
Participation involves random assignment to either the new treatment or standard care.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old – there's no upper age limit. The study is open to both men and women.

Crucially, you would have recently had surgery to remove bowel cancer that had spread only to your liver. This means the cancer shouldn't have spread to any other parts of your body, like your lungs or bones.

Your doctors would also need to determine that you are in a specific 'low clinical risk' group. This means that based on certain medical assessments, your cancer is considered less likely to spread aggressively. This particular detail is important for this specific study.

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?
Have you had surgery for bowel cancer that spread only to your liver?
Has your doctor said there's no cancer spread to other parts of your body?
Has your medical team indicated you are in a 'low clinical risk' group for your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the special liver-directed chemotherapy or standard care. This is like flipping a coin, ensuring fair comparison. The liver-directed chemotherapy involves a pump being surgically placed to deliver the medication.

You would have regular doctor's appointments, scans, and blood tests to monitor your health, how the treatment is working, and to check for any side effects. You would also be asked to fill out questionnaires about your quality of life. The total duration of your participation in the study, including follow-up appointments, would be determined by the study protocol, potentially lasting several years to track long-term outcomes. The specific number of visits and tests would be clearly explained by the study team.

Potential risks and benefits

Taking part might offer you access to a new treatment that isn't widely available yet, which could potentially help you live longer without your cancer returning. However, like all medical treatments, there are potential risks, including side effects from the chemotherapy medicines or complications from the pump surgery. Your doctors will monitor you closely for any problems. Remember, you can choose to leave 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 does 'hepatic arterial infusion pump chemotherapy' mean?

It's a way of giving chemotherapy medicine directly into the main artery that supplies blood to your liver, using a small pump. This aims to get more medicine to the cancer in your liver.

Why is this study only for people with 'low clinical risk'?

The researchers want to see if this treatment is particularly effective for people whose cancer is less aggressive and easier to control, to find out where it might help the most.

What is 'progression free survival'?

This is a medical term for how long a person lives without their cancer growing or spreading. It's a key way to measure if a treatment is working.

Will I definitely get the new treatment if I join?

Not necessarily. This is a randomised trial, so you would be randomly assigned to either receive the special chemotherapy or the usual care. This helps to fairly compare the two.

What if I change my mind after joining the study?

You are free to withdraw from the study at any time, for any reason, without it affecting your standard medical care or treatment.