A trial comparing surgery to remove lymph nodes with no further surgery for people with melanoma (MSLT II)

Cancer type:

Melanoma
Skin cancer

Status:

Results

Phase:

Phase 3

This trial compared treatment for people who have had a lymph node removed that contained melanoma.

The trial was open for people to join between 2004 and 2014. The team published the results in 2017.

More about this trial

Doctors usually treat melanoma with surgery. They often remove the lymph node nearest to the area of melanoma as well. This node is called the sentinel lymph node. They check whether this lymph node contains any cancer cells.

If there are melanoma cells in the sentinel node, the doctors will remove the other lymph nodes in that area. But removing all the lymph nodes can cause side effects. 

When this trial was done, doctors weren’t sure whether it was best to remove all the lymph nodes straight away or not.

This trial was for people who had cancer cells in the sentinel node that had been removed. Some people went on to have surgery to remove all their lymph nodes. And some people didn’t. Those who didn’t have surgery had regular ultrasound scans.

The aims of this trial were to:

  • find out if it is better for people to have their lymph nodes removed or not
  • compare the side effects of each type of treatment

Summary of results

The research team found that it was not better to remove all the nearby lymph nodes in people who have melanoma in their sentinel node.

Trial design
This trial was for people who:

  • had already had surgery to remove their melanoma
  • had melanoma cells in the sentinel lymph node which was removed during the operation

Nearly 2,000 people joined the trial. They were put into a treatment group at random:

  • 971 had further surgery to remove their lymph nodes
  • 968 didn’t have surgery to remove their lymph nodes

The people who didn’t have surgery straight away had regular ultrasound scans. They had surgery if there were any signs of cancer in the lymph nodes on a scan.

Results
The research team looked at how many people were living, 3 years after they joined the trial. They found it was:

  • nearly 9 out of 10 people (86%) in both groups

They also looked at how many people didn’t have any signs of melanoma, 3 years after they joined the trial. They found this was:

  • nearly 7 out of 10 (68%) for those who had surgery straight away
  • more than 6 out of 10 (63%) for those who didn’t have surgery

Side effects
Surgery to remove lymph nodes can cause fluid to build up in a part of the body close to the operation site. This swelling is called lymphoedema. It affected:

  • more than 2 out of 10 people (24%) who had surgery straight away
  • less than 1 out of 10 people (6%) who didn’t have surgery straight away

Conclusion
The trial team concluded that removing lymph nodes soon after initial surgery does not help people live longer. This is for people whose sentinel lymph node contained melanoma cells.

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Marc Moncrieff

Supported by

John Wayne Cancer Institute
National Cancer Institute (NCI)
Norfolk & Norwich University NHS Trust Hospital

Freephone 0808 800 4040

Last review date

CRUK internal database number:

6531

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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