Surgical Excision Margins for Melanoma
(MelMarT-II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking oral or injected immunosuppressive agents, you may not be eligible to participate.
Is wide local excision (WLE) generally safe for humans?
How does the surgical excision margin treatment for melanoma differ from other treatments?
This treatment involves surgically removing melanoma with either a 1 cm or 2 cm margin around the tumor, which is less extensive than the historically recommended 3 to 5 cm margins. Studies suggest that these narrower margins do not increase the risk of cancer returning or affect survival rates, making it a more conservative and potentially less invasive option.26789
Who Is on the Research Team?
Michael Henderson
Principal Investigator
Peter MacCallum Cancer Centre, Australia
Marc Moncrieff
Principal Investigator
Norfolk & Norwich University Hospital
Are You a Good Fit for This Trial?
Adults over 18 with stage II primary invasive cutaneous melanoma, as defined by specific criteria, who can undergo surgery within 120 days of diagnosis. They should have a life expectancy of at least five years and be able to consent and follow the trial protocol. Those with certain types of melanoma or past cancers (except some successfully treated ones) are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Intervention
Participants undergo wide local excision with either a 1cm or 2cm margin, including sentinel lymph node biopsy and possible reconstruction
Post-Surgery Follow-up
Participants are monitored for serious adverse events and surgery-related adverse events
Long-term Follow-up
Participants are monitored for disease-free survival, local recurrence, distant disease-free survival, and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Wide Local Excision = 1cm Margin
- Wide Local Excision = 2cm Margin
Wide Local Excision = 1cm Margin is already approved in European Union, United States for the following indications:
- Primary invasive cutaneous melanoma
- Primary invasive cutaneous melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Melanoma and Skin Cancer Trials Limited
Lead Sponsor
Zuyderland Medical Centre
Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator
Canadian Cancer Trials Group
Collaborator
Cancer Trials Ireland
Collaborator