MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneou… (NCT02385214) | Clinical Trial Compass
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MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma
United States, Australia, Canada400 participantsStarted 2015-01-03
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must have a primary invasive cutaneous melanoma of Breslow thickness greater than 1 millimetre as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.
. Patients must have had the invasive primary completely excised, including any in situ component but excluding melanocytic atypia, with a narrow margin, either in one stage or more than one stage in the case where an incision or punch biopsy has previously been performed. This information, including measured margins of lateral and deep clearance must be documented on the pathology report.
. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole).
. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
. Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed by 120 days of original diagnosis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Local Melanoma Recurrence (Melanoma Specific Survival)
. Patients must be 18 years or older at time of consent.
. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.
. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
Exclusion criteria
. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.
. Patient has already undergone wide local excision at the site of the primary index lesion.
. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
. Desmoplastic or neurotropic melanoma.
. Microsatellitosis as per AJCC 2009 definition
. Subungual melanoma
. Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.
. History of previous or concurrent (i.e., second primary) invasive melanoma.