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Melanoma Margins Trial-II: Comparing 1cm vs 2cm Surgical Excision for Stage II Melanoma

This study is looking at whether removing a smaller amount of healthy skin around a melanoma (1cm margin) is as safe and effective as removing a larger amount (2cm margin) for people with Stage II cutaneous melanoma. Both approaches involve a "wide local excision" to remove any remaining melanoma cells after the initial biopsy. The study wants to see if a 1cm margin leads to similar disease-free survival (how long you live without the cancer returning) compared to a 2cm margin, measured over 0-60 months. If the smaller margin is just as safe, it could improve your quality of life. You may be able to join if you are 18 or older and have Stage II primary invasive cutaneous melanoma with specific Breslow thickness measurements. The study is currently unclear on its recruitment status.

Study design
This is an interventional study comparing two surgical procedures. It aims to enroll 2998 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for disease-free survival for up to 60 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03860883

Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

Recruiting
NAAges 18+InterventionalTreatment
Melanoma and Skin Cancer Trials Limited
~2,998 participants
Updated 2024-11-27 on ClinicalTrials.gov
What's tested:Wide Local Excision = 1cm MarginWide Local Excision = 2cm Margin

At a glance

Recruiting sites
185 of 192 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-Free Survival
Measured over 0-60 months

Conditions

Cutaneous Melanoma, Stage II

Explore related trials

Melanoma

Where it's being run

192 sites across 60 states
New York14
California13
Florida13
United Kingdom12
Ohio9
Illinois7
Pennsylvania7
Georgia6

Study leadership

  • Michael Henderson · STUDY_CHAIR · Peter MacCallum Cancer Centre, Australia
  • Marc Moncrieff · STUDY_CHAIR · Norfolk & Norwich University Hospital

Who to contact

Melanoma and Skin Cancer Trials Coordinator
[email protected]
+61 3 9903 9022
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The patient has undergone potentially curative therapy for all prior malignancies,
There has been no evidence of recurrence of any prior malignancies for at least FIVE years (with the exception of successfully treated uterine/cervical or non-melanoma skin cancers (SCCs/BCCs) with no evidence of recurrence), and
The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.

What this trial measures

  • Disease-Free Survival0-60 months

    Time from randomisation until the first clinically, histologically or radiologically confirmed recurrence of melanoma at any body site, or death from any cause.