RecruitingNAINTERVENTIONAL

Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

This study, called "Melanoma Margins Trial-II," is looking at the best way to remove a type of skin cancer called stage II melanoma. When melanoma is removed, doctors also take a small area of healthy skin around it, called a margin. This trial is comparing whether a 1cm (about half an inch) margin is as safe as a 2cm (about three-quarters of an inch) margin. The main goal is to see if there's any difference in how long people stay cancer-free between these two approaches. Researchers also hope that using a smaller margin might lead to better quality of life and fewer side effects for patients, and could also be more cost-effective for the healthcare system.

At a glance

Status

Recruiting

Phase

Sponsor

Melanoma and Skin Cancer Trials Limited

Enrolment target

2,998

Start

17 Dec 2019

Estimated completion

31 Dec 2034

Cutaneous Melanoma, Stage II

What is this study about?

When doctors remove a skin cancer called melanoma, they also take away a small amount of healthy-looking skin around it. This is called a "safety margin" or "excision margin." It's done to make sure all the cancer cells are gone. For Stage II melanoma, doctors usually recommend a 1cm or 2cm margin, but we don't fully know if one size is better than the other, or if a smaller margin is just as safe.

This study is designed to find out if removing melanoma with a 1cm safety margin is just as effective as using a 2cm margin for patients with Stage II melanoma. The main thing they will be looking at is whether the cancer is more or less likely to come back in either group. If a smaller margin is just as effective at preventing the cancer from returning, it could mean a lot for patients. For example, a smaller surgery might lead to a smaller scar, quicker recovery, and generally make life better for patients after their operation.

Beyond just the cancer coming back, the researchers will also look at how these different margin sizes affect patients' daily lives and well-being. They want to understand if a smaller surgery improves quality of life, reduces pain or discomfort, and has fewer other side effects. The study will also consider the financial impact on the NHS and society, as a less extensive surgical procedure could potentially save resources.

Key takeaways

This study compares 1cm vs. 2cm surgical margins for Stage II melanoma.
It aims to see if a smaller margin is equally safe and improves patient quality of life.
Participants will be randomly assigned to one of the two margin sizes.
The study assesses if the cancer returns and how treatment affects daily life.
It also considers the economic impact of different margin sizes on healthcare.

Who may be eligible?

To join this study, you must be 18 years or older and have a specific type of skin cancer called Stage II melanoma. This would have been confirmed by a doctor after a small sample (biopsy) of your skin was checked. The melanoma must be on your skin, like your head, neck, body, arms, or legs.

The doctors need to be able to remove the melanoma with a 2cm clear safety border around the biopsy scar. Your surgery should happen fairly quickly after your melanoma diagnosis, and you need to be well enough to take part. You should also generally be in good health and expect to live for at least another five years, not counting your melanoma.

People who have had other cancers in the past might be able to join if those cancers were successfully treated and haven't come back for at least five years. However, you can't have an uncertain diagnosis, and you must be able to understand and agree to take part in the study and follow its plan.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Stage II melanoma that's on your skin?
Can a 2cm clear safety border be removed around your melanoma or biopsy scar?
Are you generally in good health and can follow a study plan?
Do you have a life expectancy of at least 5 years, not counting your melanoma?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be randomly assigned to have your melanoma removed with either a 1cm or a 2cm safety margin. This means neither you nor your doctor will choose which size margin you get; it's decided by chance, like flipping a coin, to ensure the comparison is fair. The surgery will happen within a month of you being assigned to a group.

After your surgery, you will have regular follow-up appointments with your medical team to check on your health and ensure the melanoma hasn't returned. These check-ups will likely involve physical exams and possibly other tests over several years. The study will also ask you questions about your quality of life and any side effects you experience, to help understand the full impact of each treatment.

Potential risks and benefits

Taking part in this study might offer you the benefit of knowing that your treatment is being carefully monitored, and you’ll contribute to valuable research that could help future patients. There's a chance that the smaller 1cm margin might lead to a smaller scar and a quicker physical recovery. However, there are always risks with any surgery, such as bleeding, infection, or scarring. Although researchers believe both margin sizes are safe, the study is designed to confirm this, so there is a small uncertainty. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (192)

University of South Alabama Mitchell Cancer Institute
Mobile, United States· Recruiting
Banner MD Anderson Cancer Center
Gilbert, United States· Recruiting
Mayo Clinic Phoenix
Phoenix, United States· Recruiting
University of Arkansas for Medical Sciences
Little Rock, United States· Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, United States· Recruiting
Los Angeles General Medical Center
Los Angeles, United States· Recruiting
Los Angeles General Medical Center
Los Angeles, United States· Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, United States· Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, United States· Recruiting
The Angeles (Cedars-Sinai Medical Center and its Affiliates)
Los Angeles, United States· Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, United States· Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Orange, United States· Recruiting

+180 more sites — see the official record for the full list.

Common questions

What is 'Stage II melanoma'?

Stage II melanoma means the cancer has grown into the skin but hasn't spread to nearby lymph nodes or other parts of the body. Its size and how deeply it has grown are important factors.

What is an 'excision margin'?

An excision margin is the small amount of healthy skin doctors remove around the melanoma during surgery to make sure all cancer cells are gone. This study is comparing a 1cm margin to a 2cm margin.

Why is this study comparing two different margin sizes?

The study wants to see if a slightly smaller margin (1cm) is just as effective at preventing the melanoma from coming back as a larger one (2cm). If it is, a smaller surgery might be better for patients.

Will I get to choose my margin size?

No, if you join the study, you'll be randomly assigned to either the 1cm or 2cm margin group. This helps make the study’s results fair and reliable.

What does 'disease-free survival' mean?

Disease-free survival means how long a person lives without the melanoma returning. It's a key measure to see how effective the treatments are.

How to find out more

Melanoma and Skin Cancer Trials Coordinator

melmart@masc.org.au +61 3 9903 9022 Official trial record

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