Purpose of this Study
If people join this study, they will be placed into one of two groups by chance. One group will have the usual surgery to remove the melanoma along with a procedure to check nearby lymph nodes. The other group will have only the surgery to remove the melanoma.
After surgery, doctors will watch for any signs that the melanoma has come back. Participants will complete surveys about their health and quality of life every four months for the first two years. After that, they will continue seeing their doctors every six months for three more years. If the melanoma returns after the first two years, participants will be asked to complete another survey at that time.
Who Can Participate?
Eligibility
People can join this study if they are 75 years old or older and have early stage melanoma. They must be healthy enough to have surgery and be able to do most daily activities. They must be eligible for both the standard surgery to remove the melanoma and the procedure that checks nearby lymph nodes.
People cannot join if they have certain medical problems that make surgery unsafe, an active infection, or conditions that make the lymph node procedure impossible or very difficult to perform. People who have had other cancers may still be able to join if those cancers are not expected to affect the study results.
Age Range
75-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is looking at whether people with early stage melanoma can do just as well with a simpler surgery. Usually, treatment includes removing the melanoma and checking nearby lymph nodes to see if the cancer has spread. Researchers want to learn if removing only the melanoma works just as well.
The goal is to find out if people can avoid the extra lymph node procedure without increasing the chance of the melanoma coming back. Researchers also want to see if the simpler surgery can improve quality of life and overall well being.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Protocol EA6244, A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients
Principal Investigator
Jay
Lee
Protocol Number
PRO00120444
NCT ID
NCT07068074
Phase
III
Enrollment Status
Open to Enrollment