RecruitingNAINTERVENTIONAL

The DRAGON 2 Trial

The DRAGON 2 trial is investigating new ways to treat bowel cancer that has spread to the liver, specifically when surgery might be difficult because not enough healthy liver would be left. Traditionally, a procedure called PVE (portal vein embolisation) helps the remaining healthy liver grow bigger before surgery. This study compares PVE with a newer method called PVE/HVE (portal vein and hepatic vein embolisation). PVE/HVE is thought to make the liver grow faster and larger, potentially making surgery safer and possible for more patients. The study aims to see if PVE/HVE is a better option than PVE alone, helping more people undergo life-saving liver surgery by encouraging their liver to regenerate effectively.

At a glance

Status

Recruiting

Phase

Sponsor

Maastricht University

Enrolment target

348

Start

01 Apr 2022

Estimated completion

30 Jun 2029

Colorectal Cancer Liver Metastases (CRLM)Small Future Liver Remnant (FLR)

What is this study about?

Bowel cancer can sometimes spread to the liver. When this happens, doctors sometimes recommend surgery to remove these growths, which can significantly improve a person's chances of recovery. However, to make sure you stay healthy after surgery, doctors need to be sure there's enough healthy liver left behind to do its job. If there isn't enough, surgery can be very risky.

To increase the amount of healthy liver, doctors can perform a procedure to encourage the liver to grow before the main surgery. The usual way to do this is called PVE, where some blood vessels to the part of the liver with cancer are blocked off. This encourages the healthy part of the liver to grow larger. This study is looking at a new, similar procedure called PVE/HVE. This new procedure blocks off a few more blood vessels, and early studies suggest it might help the liver grow bigger and faster.

The DRAGON 2 trial wants to find out if PVE/HVE is truly better than the standard PVE procedure. By comparing the two treatments, doctors hope to make liver surgery safer and available to more people with bowel cancer that has spread to the liver. This research is important because it could improve the treatment options and outcomes for many patients.

Key takeaways

The study looks at new ways to prepare the liver for surgery in bowel cancer that has spread.
It compares a standard procedure (PVE) with a potentially better one (PVE/HVE).
The goal is to help the liver grow bigger and faster, making surgery safer.
This could allow more people to have life-saving liver surgery.
Participation involves being randomly assigned to one of two treatment groups.

Who may be eligible?

This study is looking for adults aged 18 and over, both men and women, who have bowel cancer that has spread to their liver. Your doctors must think that the liver cancer can be removed with surgery, but that you don't have enough healthy liver to safely go ahead with it right now. You might also be able to join if you have very few, treatable cancer spots in your lungs or brain.

There are also reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you can't or won't use contraception if you're a woman of childbearing age. You also wouldn't be able to join if you have other serious health problems that would make the treatment too risky, or if your cancer has spread widely to other parts of your body that can't be treated. Also, if the way your liver is shaped or where your tumours are located makes the new PVE/HVE procedure impossible, you wouldn't be able to participate.

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.

I am 18 years old or older.
I have bowel cancer that has spread to my liver.
Despite treatment, my doctors think my liver might not be big enough for safe surgery right now.
I do not have other serious health problems that would make participating risky.
I am not pregnant or breastfeeding, and if female, I am willing to use contraception.

Answer every question to see your result.

What does participation involve?

If you decide to join the DRAGON 2 trial, you will be randomly assigned to receive either the standard PVE procedure or the newer PVE/HVE procedure. This is like flipping a coin to decide which group you're in, ensuring a fair comparison. Both procedures involve a hospital stay and a recovery period, during which your doctors will closely monitor your liver's growth and overall health. You will have regular scans and check-ups to see how you are responding to the treatment and to prepare for your main liver surgery, which would happen a few weeks later. The total duration of your participation will depend on how quickly your liver grows and when your surgery is scheduled, but it would involve several hospital visits and ongoing follow-ups as part of your cancer treatment journey.

Potential risks and benefits

Participating in this study might offer you the chance to receive a newer treatment (PVE/HVE) that could potentially help your liver grow more effectively, making surgery safer and more likely to succeed. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or other complications, although the new procedure has been tested and shown to be safe in earlier studies. You will be closely monitored for any problems. It's important to remember that joining a trial is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (24)

Yale New Haven Hospital
Verified postcode
New Haven, United States· Recruiting
Monash Medical Centre
Verified postcode
Clayton, Australia· Recruiting
Social Medical Center, South
Verified postcode
Vienna, Austria· Not yet recruiting
Hôpital Erasme
Verified postcode
Brussels, Belgium· Recruiting
CHU de Liège
Verified postcode
Liège, Belgium· Recruiting
CHU-UCL Namur site Godinne
Verified postcode
Yvoir, Belgium· Recruiting
UZ Gent
Verified postcode
Ghent, Belgium· Recruiting
Vancouver Coastal Health
Verified postcode
Vancouver, Canada· Recruiting
Juravinski Hospital and Cancer Centre
Verified postcode
Hamilton, Canada· Recruiting
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting
Sunnybrook Hospital
Verified postcode
Toronto, Canada· Recruiting
McGill University Health Center
Verified postcode
Montreal, Canada· Not yet recruiting

Common questions

What is 'liver regeneration'?

Liver regeneration is your liver's amazing ability to grow new, healthy tissue to replace damaged or removed parts. This study aims to kickstart that growth.

What is the difference between PVE and PVE/HVE?

Both procedures block blood vessels to encourage liver growth. PVE blocks one type of vessel (portal vein branches), while PVE/HVE blocks both these and another type (hepatic vein), which may help the liver grow quicker and larger.

Who decides which treatment I receive?

You will be randomly assigned to either the PVE or PVE/HVE group, similar to drawing straws. This ensures the study is fair and unbiased.

Will I still have my cancer surgery if my liver doesn't grow enough?

The goal of these procedures is to make surgery possible. If your liver doesn't grow enough to make surgery safe, your doctors will discuss other treatment options with you.

How long will I be involved in this study?

Your involvement will cover the preparation for surgery, the procedure itself, and follow-up care. The exact duration depends on your individual response and treatment plan.

How to find out more

Sinéad James, MD, PhD-candidate

sinead.james@mumc.nl +31 638463945 Official trial record

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