RecruitingNAINTERVENTIONAL

Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer

The ARMANI study focuses on people with bowel cancer that has spread to the liver, specifically those with a genetic change called a RAS mutation. When doctors remove these liver tumours, they can do so in two main ways: an 'anatomical resection' (AR), which follows the liver's natural sections, or a 'non-anatomical resection' (NAR), which removes only the tumour and a small amount of surrounding tissue. This study wants to find out if AR surgery leads to a better long-term outcome for these specific patients compared to NAR, meaning they might live longer without the cancer coming back in the liver. It's the first study of its kind to test if tailoring surgery based on a tumour's genetic makeup is more effective and safe.

At a glance

Status

Recruiting

Phase

Sponsor

Technische Universität Dresden

Enrolment target

240

Start

01 Jan 2021

Estimated completion

01 Dec 2027

Colorectal Liver Metastasis

What is this study about?

When bowel cancer spreads to the liver, these new growths are called liver metastases. For many years, doctors have been working to find the best ways to treat these, and often surgery is a key part of the plan. This particular study, called ARMANI, is looking closely at patients whose bowel cancer has a specific genetic change, known as a RAS mutation. This genetic information might help doctors decide on the most effective type of surgery.

Currently, surgeons can remove liver tumours in a couple of ways. One method is called an 'anatomical resection' (AR). This means removing the tumour along with a whole section of the liver, following the liver's natural boundaries. The other method is a 'non-anatomical resection' (NAR), where only the tumour and a small area around it are taken out, trying to save as much healthy liver tissue as possible. While there's a general trend to save liver tissue, some early information suggests that for patients with RAS-mutated bowel cancer, removing a larger, anatomical section might actually be better.

The ARMANI study is designed to answer this important question. It will compare these two surgical approaches in patients with RAS-mutated bowel cancer spread to the liver. Researchers want to see if one type of surgery helps patients live longer without the cancer returning to the liver, and they will also look at side effects, recovery, and quality of life. The results could change how surgeons decide to operate on these specific patients, making treatment more personalised and potentially more effective.

Key takeaways

This study compares two types of liver surgery for bowel cancer that has spread to the liver.
It focuses specifically on patients whose cancer has a 'RAS mutation'.
The aim is to find out if one surgery type helps patients live longer without the cancer returning in the liver.
Participants will be randomly assigned to one of the two surgery groups.
The study also looks at recovery, side effects, and quality of life after surgery.
Results could lead to more personalised and effective surgical treatments.

Who may be eligible?

To be considered for this study, you would need to have bowel cancer that has spread to your liver. A key requirement is that your cancer must have a specific genetic change, known as a RAS mutation (this will be checked by your doctors). The doctors must believe that all of the liver tumours can be removed completely during surgery.

Both anatomical (removing a whole section of the liver) and non-anatomical (removing just the tumour) types of surgery must be possible for you. You need to be at least 18 years old, and be able to understand what the study involves and agree in writing to take part.

There are also some reasons why you wouldn't be able to join. For example, if your cancer has spread to other parts of your body besides the liver, or if you've had another type of cancer within the last five years (with a few exceptions like successfully treated cervical or non-melanoma skin cancer). You also wouldn't be suitable if you have other serious health issues that would make it difficult for you to participate fully or understand the risks.

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 to your liver?
Has your doctor confirmed your cancer has a RAS gene mutation?
Are you at least 18 years old?
Are your liver tumours believed to be completely removable by surgery?
Has your cancer NOT spread to other parts of your body outside the liver?
Could both types of liver surgery (anatomical or non-anatomical resection) be performed on you?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would first go through a random process, like flipping a coin, to decide which type of liver surgery you will have – either an anatomical resection (removing a section of the liver) or a non-anatomical resection (removing just the tumour). You won't be able to choose which type of surgery you receive; this is to ensure the study is fair and unbiased.

After your surgery, the research team will closely monitor your recovery and health. They will track how well you are doing, if the cancer returns in the liver, and your overall quality of life. This will involve regular follow-up appointments, scans, and possibly questionnaires over a period of time to gather all the necessary information. The exact number and timing of visits will be explained in detail by the study team, but generally clinical trials involve careful monitoring for several years.

Potential risks and benefits

Taking part in a study like this means you might receive a treatment that could be more effective for your specific type of cancer, potentially leading to a longer time without the cancer returning in your liver. You'll also be closely monitored by a specialist team. However, as with any surgery, there are risks involved, such as bleeding, infection, or complications from anaesthesia. Both types of surgery (anatomical and non-anatomical resection) carry their own risks, and these will be thoroughly discussed with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (37)

Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University
Verified postcode
Mannheim, Germany· Recruiting
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Verified postcode
Dresden, Germany· Recruiting
Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach
Verified postcode
Ansbach, Germany· Recruiting
Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital
Verified postcode
Augsburg, Germany· Recruiting
Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, Campus Benjamin Franklin Berlin
Verified postcode
Berlin, Germany· Recruiting
Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hospital Bonn
Verified postcode
Bonn, Germany· Recruiting
Surgical Clinic, Municipal Hospital Braunschweig gGmbH
Verified postcode
Braunschweig, Germany· Recruiting
Cancer Center, Helios Amper-Hospital Dachau
Verified postcode
Dachau, Germany· Recruiting
Surgical Clinic, Dortmund Hospital
Verified postcode
Dortmund, Germany· Recruiting
Clinic for General and Visceral Surgery, Municipal Hospital Dresden
Verified postcode
Dresden, Germany· Recruiting
Clinic for General, Visceral and Pediatric Surgery, University Hospital Düsseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
Surgical Clinic, University Hospital Erlangen
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What does 'RAS mutation' mean?

RAS mutation refers to a specific genetic change found in some cancer cells. It helps doctors understand more about your cancer and might guide treatment decisions.

What is the difference between the two types of surgery?

An 'anatomical resection' removes a whole section of the liver where the tumour is. A 'non-anatomical resection' aims to remove only the tumour and a small margin, preserving more healthy liver tissue.

Will I get to choose my surgery type?

No, if you join the study, a computer will randomly decide which of the two surgical methods you will receive. This helps ensure fair and unbiased results for the research.

What does 'long-term outcome' mean in this study?

In this study, 'long-term outcome' mainly refers to how long patients live without the cancer returning in their liver (called 'intrahepatic disease-free survival').

Where is this study taking place?

This study is being conducted in 11 major liver surgery centres across Germany. It's a collaboration to gather enough information to make a strong conclusion.

How to find out more

Jürgen Weitz, Prof Dr med

juergen.weitz@ukdd.de +49-(0)351 458 4850 Official trial record

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