EA6244 Management of Tx Naive Melanoma in Elderly Pts

What is the 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.

What is the Condition Being Studied?

People that have early-stage melanoma and you are the age of 75 or older.

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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.

Study Details

Full Title
Protocol EA6244, A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients
Principal Investigator
Assistant Professor of Surgery
Protocol Number
IRB: PRO00120444
NCT: NCT07068074
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
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