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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