Excision Margins for Melanoma
(MelMarT 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 a primary invasive cutaneous melanomas \>=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients
Will I have to stop taking my current medications?
The trial requires that participants do not take oral or injected immunosuppressive medications during the study or within 6 months before joining. If you are on such medications, you may need to stop them to participate.
Is wide local excision (WLE) generally safe for humans?
How does the treatment of wide local excision with 1cm or 2cm margins for melanoma differ from other treatments?
Wide local excision with 1cm or 2cm margins is a surgical treatment for melanoma that focuses on removing the tumor with a specific margin of healthy tissue around it. This approach is unique because it uses smaller margins compared to traditional methods, which often recommend wider margins of 3 to 5 cm, and it is performed meticulously in an operating room, often under light general anesthesia.36789
What data supports the effectiveness of the treatment Wide Local Excision for melanoma?
Wide Local Excision (WLE) is a common treatment for melanoma, aiming to remove cancerous tissue with a margin of healthy skin to reduce the risk of cancer returning. Although the research does not directly address effectiveness, it suggests that WLE is a standard practice, indicating its general acceptance and use in managing localized melanoma.123610
Who Is on the Research Team?
Marc Moncrieff
Principal Investigator
Norfolk & Norwich University Hospital
Prof Michael Henderson
Principal Investigator
Peter MacCallum Cancer Center
Are You a Good Fit for This Trial?
Adults over 18 with a life expectancy of at least 10 years and an ECOG score of 0-1, who have had a primary cutaneous melanoma thicker than 1mm completely excised. They must be able to follow the trial protocol and have no history of organ transplants, immunosuppressive treatments in the past six months, or other cancers within five years (with some exceptions).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo wide local excision with either a 1cm or 2cm margin, including sentinel lymph node biopsy and possible reconstruction
Follow-up
Participants are monitored for local melanoma recurrence, adverse events, and quality of life assessments
Long-term Follow-up
Participants are monitored for overall survival and recurrence-free 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
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator
Peter MacCallum Cancer Centre, Australia
Collaborator