RecruitingPHASE3INTERVENTIONAL

Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver

This study focuses on treating bowel cancer that has spread to the liver but not elsewhere. For some people, surgery isn't immediately possible. The trial wants to see if a combination of treatments can shrink the cancer more effectively. This involves standard chemotherapy given through a vein, chemotherapy delivered directly into the liver's artery, and 'targeted' drugs. Researchers hope this combined approach will be more effective at shrinking tumours and give patients a better chance without increasing side effects too much. It's comparing different ways of combining these treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Federation Francophone de Cancerologie Digestive

Enrolment target

348

Start

01 Dec 2016

Estimated completion

01 Sep 2028

Colorectal Neoplasms

What is this study about?

This research study is investigating new ways to treat bowel cancer when it has spread to the liver. This type of cancer is quite common, and often, the cancer spreads to the liver. Sometimes, it's not possible to remove these liver tumours with surgery straight away. In these situations, doctors typically use treatments like chemotherapy to try and shrink the tumours.

This study is looking at an advanced way to treat these liver-focused tumours. It combines several approaches: standard chemotherapy given into a vein (like Oxaliplatin and 5-FU), alongside newer 'targeted therapies' (like Panitumumab or Bevacizumab, which focus on specific parts of cancer cells). A key part of this study is also giving some chemotherapy (Oxaliplatin) directly into the artery that feeds the liver. This aims to deliver the drug right to the cancer cells in the liver, potentially reducing side effects elsewhere in the body.

The main goal is to see if this combination of treatments can shrink the liver tumours more effectively and for a longer time, compared to current standard treatments. Researchers hope this will improve the chances for patients to either have surgery later or to live longer with good quality of life. The study is comparing different combinations of these medicines to find the best and safest approach.

Key takeaways

New study for bowel cancer that has spread to the liver.
Combines standard chemotherapy with directly delivered liver chemotherapy and targeted drugs.
Aims to shrink liver tumours more effectively than current treatments.
Could help more patients become eligible for surgery.
Compares different treatment combinations to find the best approach.

Who may be eligible?

To join this study, people need to have bowel cancer that has definitely spread to their liver, but not to many other places. If there are small spots in the lungs, that might be okay, but not many. We also need to know specific genetic information about their cancer called 'RAS mutation status'. Participants need to be at least 18 years old and generally well enough to manage treatment, with good blood test results for their liver and kidneys, and a healthy heart.

There are also reasons why someone might not be able to join. For example, if they could have surgery right away to remove the liver tumours, or if they've had certain heart problems or major surgery recently. People who have uncontrolled high blood pressure or issues with their liver artery (where the special chemotherapy would be given) would also not be able to take part. It’s important that participants haven’t had chemotherapy recently, within the last 12 months, unless it was a very specific type given before or after surgery.

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.

Do you have bowel cancer that has spread specifically to your liver?
Are you 18 years of age or older?
Are you generally well and fit enough for treatment?
Have you *not* had chemotherapy in the last 12 months (unless it was brief treatment before or after surgery)?
Have your doctors determined that surgery isn't an immediate option for your liver tumours?
Do you have healthy kidney and liver function, and a healthy heart?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive different types of cancer treatments. This will include chemotherapy given through a drip into your arm, similar to standard treatments. You might also receive a 'targeted therapy' drug, also given through a drip. A key part of this study involves a procedure to deliver chemotherapy directly into the artery that goes to your liver. This usually involves a small procedure to place a thin tube.

You will have regular hospital visits for these treatments and to have check-ups, blood tests, and scans to see how the treatment is working. The exact number of visits and follow-up will vary depending on which treatment group you are in and how you respond. The doctors and nurses will monitor you closely for any side effects. The total length of your participation will depend on how your cancer responds to the treatment and your overall health, but it could last for many months.

Potential risks and benefits

Taking part in this study might offer a chance for more effective treatment for your cancer, potentially shrinking tumours more or for longer. However, like all medical treatments, there are potential risks and side effects from the chemotherapy and targeted drugs, which your doctor will explain in detail. These can include tiredness, sickness, and changes to blood counts. Delivering chemotherapy directly to the liver might also have specific risks related to that procedure. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (49)

Hôpital Erasme
Verified postcode
Brussels, Belgium· Recruiting
Chu Hotel Dieu
Verified postcode
Angers, France· Recruiting
Institut de Cancérologie de l'Ouest
Verified postcode
Angers, France· Recruiting
Hôpital Privé d'Antony
Verified postcode
Antony, France· Recruiting
CH Henri Duffaut
Verified postcode
Avignon, France· Not yet recruiting
Institut du cancer Avignon Provence
Verified postcode
Avignon, France· Recruiting
Ch Cote Basque
Verified postcode
Bayonne, France· Recruiting
Clinique Belharra
Verified postcode
Bayonne, France· Recruiting
Centre Hospitalier
Verified postcode
Beauvais, France· Not yet recruiting
Institut Bergonié
Verified postcode
Bordeaux, France· Recruiting
Polyclinique Bordeaux Nord
Verified postcode
Bordeaux, France· Recruiting
Infirmerie Protestante de Lyon
Verified postcode
Caluire-et-Cuire, France· Recruiting

Common questions

What is 'targeted therapy'?

Targeted therapy drugs work by focusing on specific differences in cancer cells, aiming to stop them from growing and spreading, often with fewer side effects than traditional chemotherapy.

What does 'intra-arterial chemotherapy' mean?

This means chemotherapy is given directly into the artery that supplies blood to the liver, so the medicine goes straight to the tumour, potentially making it more effective in that area.

Will I have surgery if I join this study?

This study aims to shrink liver tumours so surgery might become an option later, but it's not the first step. The goal is to make surgery possible for more people.

How long will the treatment last?

The length of treatment depends on your response and how well you tolerate it. Your medical team will discuss the expected duration with you.

Can I still get my usual care if I don't join?

Absolutely. Deciding not to join a study will not affect the high standard of care you receive for your cancer.

How to find out more

Sofia JOURDAN

sofia.jourdan@u-bourgogne.fr +33 (0)380393404 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.