Purpose of this Study
We are doing this study to find out how much skin should be removed from around a melanoma to lower the chances of the melanoma coming back. We don't have enough evidence to know exactly how much skin to remove around the melanoma to give people the best chance at a good outcome.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with stage II primary invasive cutaneous melanoma
- Are planning to have surgery to remove the melanoma
- Have enough skin around the melanoma to leave at least a 2 cm margin when it is resected (cut out)
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
- Are diagnosed with stage II primary invasive cutaneous melanoma
- Are planning to have surgery to remove the melanoma
- Have enough skin around the melanoma to leave at least a 2 cm margin when it is resected (cut out)
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
What is Involved?
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:
- One group will have surgery that removes a 1-cm margin of health skin from around the melanoma
- The other group will have surgery that removes a 2-cm margin of health skin from around the melanoma
After surgery, your doctor will continue to follow your condition for 5 years. During the first 2 years after surgery, you will visit the study doctor 3, 6, 12, 18, and 24 months after surgery. After that, you will visit the study doctor once a year.
- One group will have surgery that removes a 1-cm margin of health skin from around the melanoma
- The other group will have surgery that removes a 2-cm margin of health skin from around the melanoma
After surgery, your doctor will continue to follow your condition for 5 years. During the first 2 years after surgery, you will visit the study doctor 3, 6, 12, 18, and 24 months after surgery. After that, you will visit the study doctor once a year.
Study Details
Full Title
SWOG S2015, Melanoma Margins Trial (MelMarT-II): A Phase III, multi-centre, multi-national randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma
Principal Investigator
Jay
Lee
Protocol Number
PRO00111628
NCT ID
NCT03860883
Phase
N/A
Enrollment Status
OPEN TO ACCRUAL