Neoplasms

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Melanoma

Melanoma, Cutaneous Malignant

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Neoplasms, Nerve Tissue

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1cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction

2 cm Wide Local Excision margin + Sentinel Lymph Node Biopsy +/- Reconstruction

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.

Wide Local Excision = 1cm Margin

Wide Local Excision = 2cm Margin

Melanoma and Skin Cancer Trials Coordinator

John H Howard, MD

Tiffany Fulford

Mark Gimbel

Sandra Ortega

Barbara A Pockaj, MD

Courtney Nelson

Michail Mavros

Dr Mark Faries

Jeremy Harris

Amanda Kirane, MD FACS

Patrick Yuan

Tatjana Kolevska, MD

Desiree Goldstein

James Clune

Geoffrey T Gibney

Marc Boisvert, MD

Nicolas Rojas

Konstantinos Chouliaras

James W Jakub

Manuel Molina

Jonathan Zager

Michael Lowe, MD

Rachel Mock

Dr Michael Lowe

Professor Keith Delman

Charisse Ellis

Nicole Kounalakis

Margaret Ferreira

Dr. Nicole Kounalakis

Yana Puckett, MD

Stephanie Reyes

Jeffrey Wayne

Sigrun Hallmeyer, MD

Cheryl Korabik

Luke Selby

Erin Burke

Edward McCarron

Kathleen Yost

Renee Porter

Ryan Fields

Srikant Nannapaneni

Bradley Reames

Adam Berger

Professor Adam Berger

Alan Kadison, MD

Diane Delliliune

Shalana O'Brien

Alexa Amoroso

Erica Friedman

Associate Professor Danielle Bello

James Nitzkorski

Karley Flinn

Paul Barr

Daniel Thomas, MD

Laine Abernathy

Paul Barr, MD

Sarah Cawley

David W Ollila

Jay Lee

Nasreen Vohra

Preston Steen

Luke Rothermel

James Ouellette

Jeffrey Sussman

Joal Joal

William Dooley

Christian Ellis, DO

Trisha Strubhar

Sandeep Mashru

Darius Desai, MD

Amy Grossman

Darius Desai

Dr Stephanie Greco

David Bertsch, MD

Susan Hadlock

Andrea Abbott

Jeffrey Gershenwald

Fedrico Tozzi, MD

Samantha Bankston

Tawnya Bowles

Kevin Adams

Professor John Hynstrom

Jessica Cintolo-Gonzalez, MD

Elizabeth Abrecht

Lynn Dengel

Giao Phan

Kristin Campbell

Heather Neuman

Sam Hanson

Rohit Sharma

Sigrun Hallmeyer

Jennifer Bruening

Chloe Papageorgio

Dr Rebecca Read

Emily Baxter

Dr Krishna Rao

Pablo Fernandez-Peñas

Prof Pablo Fernandez-Peñas

Michael Henderson

Marc Moncrieff

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.

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.

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)

Time from randomisation to clinically, histologically or radiologically confirmed recurrence of melanoma

Time from randomisation to any clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes

Time from randomisation to any clinically, histologically or radiologically confirmed distant recurrence of melanoma

Time from randomisation to death due to melanoma

Time from randomisation to death from any cause

Measured by FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire - It consists of two subsections: The FACT-G subsection is a 27-item compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is considered appropriate for use with patients with any form of cancer. The Melanoma Surgery Subscale evaluates melanoma-specific symptoms such as surgical morbidity and side effects.

Measured by EuroQoL EQ-5D-5L questionnaire - This tool contains 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

The following surgical adverse events will be recorded from the time of surgery to 90 days following surgery (inclusive):

* wound dehiscence
* seroma/haematoma
* haemorrhage
* infection
* skin graft failure
* necrosis of flap used for reconstruction
* deep venous thrombosis
* urinary tract infection
* pneumonia
* cardiac complications
* lymphoedema

An Adverse Event (AE) is any untoward medical occurrence in a participant administered a treatment which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the treatment timing, whether or not considered related to the treatment. An AE is any adverse change (developing or worsening) from the participant's pre-treatment condition, including intercurrent illness.

Data collected for economic analysis will be from hospital notes, MBS and PBS data (Australia) and patient reported outcome measures (including an employment questionnaire) at baseline, 3, 6, 12 and 24 months and at melanoma recurrence.

Spots Global Cancer Trial Database for wide local excision = 1cm margin