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

Active:	Yes
Cancer Type:	Melanoma	NCT ID:	NCT03860883
Trial Phases:	Phase III	Protocol IDs:	02.18 (primary) NCI-2019-07264 ANZMTG 02.18
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Melanoma and Skin Cancer Trials Limited
NCI Full Details:	http://clinicaltrials.gov/show/NCT03860883

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.

Objectives

This study will determine whether there is a difference in disease-free survival rates
for patients with primary cutaneous melanoma with Breslow thickness > 2mm or 1-2mm with
ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or
2cm margin. The study is designed to be able to prove or disprove that there is no
difference in risk of the tumour recurring around the scar or anywhere else in the body
between the two groups of patients. If the study shows no risk of tumour recurrence then
we will also be able to determine how much of an impact the narrower excision has on
patients in terms of improved quality of life and reduced side effects from the surgery
and melanoma disease. This trial will also evaluate and determine the economic impact of
narrower excision margins on the health services and society in general.

Treatment Sites in Georgia

St. Joseph's /Candler Health System, INC
5353 Reynolds Street
Savannah, GA 31405
912-819-5723

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