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Procedure
Excision Margins for Melanoma (MelMarT Trial)
Phase 3
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year
Awards & highlights
MelMarT Trial 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).Check my eligibility
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.See study design
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.
MelMarT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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.
Select...
I am 18 years old or older.
Select...
My melanoma originates from the skin.
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My skin cancer is deeper than 1mm according to a biopsy.
MelMarT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Melanoma
Secondary outcome measures
Adverse events
Health System Resource Use
Overall Survival
+3 moreMelMarT 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
16 Previous Clinical Trials
6,272 Total Patients Enrolled
Norfolk and Norwich University Hospitals NHS Foundation TrustOTHER
50 Previous Clinical Trials
28,254 Total Patients Enrolled
Peter MacCallum Cancer Centre, AustraliaOTHER
95 Previous Clinical Trials
25,107 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My skin condition is possibly cancerous but not confirmed.The presence of microsatellite instability as defined by the AJCC 2009 guidelines.My melanoma is located on specific areas like fingertips, nose tip, eyelids, ears, or internal organs.I have had surgery to remove a large area around my primary cancer spot.My melanoma is either desmoplastic or neurotropic.My main cancer treatment and tests were done within 4 months of diagnosis.My life expectancy is over 10 years, not counting my melanoma.I am fully active or restricted in physically strenuous activity but can do light work.I am a cancer survivor with no recurrence for at least 5 years and considered low risk.I've had surgery to repair a wound with my own tissue, and they can't tell if all the cancer was removed.I have had an organ transplant.I haven't had any cancer except for certain skin or uterine/cervical cancers in the last 5 years.I am not planning to have radiation therapy at the melanoma site after surgery.I have had melanoma before or have another melanoma besides the one being treated.I had surgery to remove lymph nodes affected by melanoma.I haven't taken any immune-weakening drugs by mouth or injection in the last 6 months.My cancer was fully removed with surgery, and this is confirmed in my pathology report.A 2cm clear area can be safely removed around my melanoma or biopsy scar.I have melanoma under my nail.I am 18 years old or older.I cannot have or am not eligible for a sentinel lymph node biopsy.My melanoma originates from the skin.My melanoma has spread beyond the original site.My skin cancer is deeper than 1mm according to a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A Wide Local Excision = 1cm Margin
- Group 2: Arm B Wide Local Excision = 2cm Margin
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment and enrollment still available for this research project?
"While this particular trial is no longer recruiting, interested parties can refer to clinicaltrials.gov to find the 843 other trials currently enrolling patients."
Answered by AI
Has the FDA cleared Wide Local Excision with a 1cm Margin for use?
"Wide Local Excision = 1cm Margin falls into Phase 3 of clinical trials. This means that, while there is some evidence of efficacy, the primary focus is on safety. Power rates this procedure as a 3 on a scale of 1 to 3."
Answered by AI
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