SWOG S2015: Comparing Resection Options in Melanoma Removal

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.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

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 Enrollment
ClinicalTrials.gov