Active not recruitingNAINTERVENTIONAL

MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

This research, called the MelmarT trial, is comparing two types of surgery for a common skin cancer called melanoma. When melanoma is removed, doctors also take a small area of healthy skin around it, called a 'margin'. This study wants to find out if taking a 1cm margin (a slightly smaller cut) is just as safe as taking a 2cm margin, for melanomas that are 1mm thick or more. They are looking to see if the cancer is less likely to return and if patients live just as long, while also checking if a smaller cut leads to a better quality of life and fewer side effects. This could potentially reduce pain and lessen the impact on daily life for patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Melanoma and Skin Cancer Trials Limited

Enrolment target

400

Start

03 Jan 2015

Estimated completion

05 Aug 2026

Cutaneous Melanoma by AJCC V7 Stage

What is this study about?

When you have a type of skin cancer called melanoma, doctors usually recommend surgery to remove it. This surgery involves taking out the melanoma itself, plus a small edge of healthy skin around it. This healthy edge is called a 'margin', and it helps to make sure all the cancer cells are gone. Currently, for certain melanomas, a 2cm margin (about an inch) is often removed.

This study, called MelmarT, is designed to see if a smaller 1cm margin (about half an inch) is just as effective and safe as the larger 2cm margin for people with melanomas that are at least 1mm thick. The main things the researchers want to find out are if the cancer is equally unlikely to come back near the surgery site, and if people live just as long with a 1cm margin compared to a 2cm margin. They also want to understand if a smaller cut can make a big difference to your quality of life, perhaps by reducing pain after surgery and improving how you feel overall.

If the study shows that the smaller margin is just as safe, it could mean that many people with melanoma might have less extensive surgery in the future. This could lead to a quicker recovery, less discomfort, and possibly a better appearance after surgery, without increasing the risk of the cancer returning. The study will also look at the financial impact this might have on the NHS and society.

Key takeaways

This study compares 1cm vs. 2cm surgical margins for melanoma.
It aims to find out if smaller cuts are equally safe and improve quality of life.
You'll be randomly assigned to one of the two treatment groups.
The research helps understand the best way to treat melanoma for future patients.
Long-term follow-up will be part of the study.

Who may be eligible?

To be able to take part in this study, you need to be an adult (18 years or older) and have been diagnosed with a primary invasive skin melanoma that is at least 1mm thick. Importantly, your melanoma must have been completely removed already with a small margin, and there must be enough healthy skin around the area for a 2cm margin to be technically possible.

There are also some other important points: You must be able to understand the study and agree to take part, and be able to keep up with the follow-up appointments. You should also be generally well, and your doctors will need to assess that you are expected to live at least 10 more years (not counting the melanoma itself).

If you have had other cancers in the past, you might still be able to join. This is usually allowed if your previous cancer was successfully treated, hasn't returned for at least five years (unless it was a certain type of skin or cervical cancer that was fully treated), and your doctor believes there's a very low chance of it coming back.

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 been diagnosed with an invasive skin melanoma that is at least 1mm thick?
Has your melanoma already been fully removed with a narrow margin?
Is your general health good enough that you are expected to live at least 10 more years?
Are you able to understand the study and attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: one group will have 1cm of healthy skin removed around your melanoma, and the other group will have 2cm removed. This decision is made by chance, like flipping a coin, to ensure a fair comparison. The main surgery, including checking some lymph nodes if needed, must happen within 120 days (about 4 months) of your original diagnosis.

After your surgery, you will have regular check-ups with your medical team. These appointments will involve monitoring your recovery, checking for any signs of the melanoma returning, and asking about your quality of life and any side effects you might be experiencing. The study will follow your health over several years to gather all the necessary information, although the precise total duration of your involvement isn't specified here, it will involve long-term follow-up.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing to medical knowledge that could improve future care for melanoma patients, and you will receive close monitoring by a specialist team. There may also be potential risks, similar to any surgery, such as infection, pain, or scarring. If you are in the 1cm margin group, the primary risk being studied is whether this smaller margin is as effective as the current standard 2cm margin in preventing recurrence. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

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

Thomas Jefferson University Hospital
Verified postcode
Philadelphia, United States
Melanoma Institute Australia - Poche Centre
Verified postcode
North Sydney, Australia
Gold Coast Melanom Clinic
Verified postcode
Coolangatta, Australia
Peter MacCallum Cancer Centre Division of Cancer Surgery
Verified postcode
Melbourne, Australia
Alfred Hospital
Verified postcode
Melbourne, Australia
Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada
Sahlgrenska University Hospital
Verified postcode
Gothenburg, Sweden
Hull and East Yorkshire Hospitals NHS Trust
Verified postcode
Hull, United Kingdom
Guy's and St Thomas' Hospital NHS Trust
Verified postcode
London, United Kingdom
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom
Mid Essex Hospital Services NHS Trust
Verified postcode
Broomfield, United Kingdom
St Helens & Knowsley NHS Trust
Verified postcode
St Helens, United Kingdom

Common questions

What is a 'margin' in melanoma surgery?

A 'margin' is the small amount of healthy skin that surgeons also remove around the melanoma, to make sure all cancer cells are taken out.

Why are doctors looking at a smaller margin?

Doctors want to see if a smaller cut (1cm instead of 2cm) is just as safe for preventing the cancer from coming back, but with the added benefits of less pain and a better quality of life for patients.

What does being 'randomly assigned' mean?

It means you'll be put into one of the two treatment groups (1cm or 2cm margin) by chance, like drawing lots, to keep the study fair and unbiased.

Will I still get my normal medical care if I join?

Yes, you will continue to receive the best possible medical care for your melanoma, regardless of whether you choose to join or leave the study.

What if I change my mind about taking part?

You are free to leave the study at any time, for any reason, and it won't affect your treatment or relationship with your medical team.