RecruitingNot ApplicableNCT03860883

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

Melanoma Margins Trial-II - A Phase III, Multi-centre Randomised Controlled Trial Investigating 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (02.18 MelMarT-II)

Sponsor

Melanoma and Skin Cancer Trials Limited

Enrollment

2,998 participants

Start Date

Dec 17, 2019

Study Type

INTERVENTIONAL

Conditions

Cutaneous Melanoma, Stage II

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 stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two surgical margin sizes (1 cm versus 2 cm) for removing stage II melanoma (a type of skin cancer thicker than 1 mm) to determine which approach leads to better outcomes. **You may be eligible if...** - You have stage II primary melanoma on the skin with a thickness greater than 1.0 mm - A 2 cm wide excision margin is technically possible at your tumor location - Surgery can be done within 120 days of diagnosis and 28 days of being assigned to a group - You are 18 years or older - You have a life expectancy of at least 5 years - You are in good general health (ECOG performance status 0-1) **You may NOT be eligible if...** - Your melanoma does not meet stage II criteria - Your melanoma is not on the skin (e.g., it is in the eye or on a mucous membrane) - A 2 cm margin is not technically achievable at your tumor site - You have a very limited life expectancy or poor general health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREWide Local Excision = 1cm Margin

A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.

PROCEDUREWide Local Excision = 2cm Margin

Locations(192)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic Phoenix

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Los Angeles General Medical Center