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Procedure

Excision Margins for Melanoma (MelMarT Trial)

N/A
Waitlist Available
Led By Marc Moncrieff
Research Sponsored by Melanoma and Skin Cancer Trials Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed by 120 days of original diagnosis
Patients must have an ECOG performance score between 0 and 1
Must not have
Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera
Patient has already undergone wide local excision at the site of the primary index lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a less radical margin of excision is just as safe for patients with a primary invasive melanoma.

Who is the study for?
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).
What is being tested?
The MelmarT trial is comparing two surgical approaches for melanoma: one group will have their cancer removed with a smaller margin (1cm) around where the tumor was, while another group will have it removed with a larger margin (2cm). The goal is to see if smaller margins are just as effective without affecting survival.
What are the potential side effects?
Since this trial involves surgical procedures rather than drugs, side effects may include typical risks associated with surgery such as pain, infection at the incision site, bleeding, scarring and potential complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My main cancer treatment and tests were done within 4 months of diagnosis.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer was fully removed with surgery, and this is confirmed in my pathology report.
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A 2cm clear area can be safely removed around my melanoma or biopsy scar.
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I am 18 years old or older.
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My melanoma originates from the skin.
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My skin cancer is deeper than 1mm according to a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My melanoma is located on specific areas like fingertips, nose tip, eyelids, ears, or internal organs.
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I have had surgery to remove a large area around my primary cancer spot.
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My melanoma is either desmoplastic or neurotropic.
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I've had surgery to repair a wound with my own tissue, and they can't tell if all the cancer was removed.
Select...
I have had melanoma before or have another melanoma besides the one being treated.
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I had surgery to remove lymph nodes affected by melanoma.
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I am not planning to have radiation therapy at the melanoma site after surgery.
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I have had an organ transplant.
Select...
I haven't taken any immune-weakening drugs by mouth or injection in the last 6 months.
Select...
I have melanoma under my nail.
Select...
I cannot have or am not eligible for a sentinel lymph node biopsy.
Select...
My melanoma has spread beyond the original site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Melanoma
Secondary study objectives
Adverse events
Health System Resource Use
Overall Survival
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A Wide Local Excision = 1cm MarginExperimental Treatment1 Intervention
ARM A: Experimental Arm Wide Local Excision = 1cm Margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Group II: Arm B Wide Local Excision = 2cm MarginActive Control1 Intervention
ARM B:Control Arm Wide Local Excision = 2cm Margin + Sentinel Lymph Node Biopsy +/- Reconstruction

Find a Location

Who is running the clinical trial?

Melanoma and Skin Cancer Trials LimitedLead Sponsor
17 Previous Clinical Trials
6,147 Total Patients Enrolled
Norfolk and Norwich University Hospitals NHS Foundation TrustOTHER
54 Previous Clinical Trials
29,032 Total Patients Enrolled
Peter MacCallum Cancer Centre, AustraliaOTHER
99 Previous Clinical Trials
26,388 Total Patients Enrolled
Marc MoncrieffPrincipal InvestigatorNorfolk & Norwich University Hospital
1 Previous Clinical Trials
2,998 Total Patients Enrolled
Michael HendersonPrincipal InvestigatorPeter MacCallum Cancer Center
2 Previous Clinical Trials
3,013 Total Patients Enrolled

Media Library

Wide Local Excision = 1cm Margin (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02385214 — N/A
Cutaneous Melanoma Research Study Groups: Arm A Wide Local Excision = 1cm Margin, Arm B Wide Local Excision = 2cm Margin
Cutaneous Melanoma Clinical Trial 2023: Wide Local Excision = 1cm Margin Highlights & Side Effects. Trial Name: NCT02385214 — N/A
Wide Local Excision = 1cm Margin (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02385214 — N/A
~37 spots leftby Dec 2025
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