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Melanoma

Melanoma Poster Presentations 2

P43: Innovation in Collaborating and Funding an International Cancer Clinical Trial

Friday, March 22, 2024

11:07am – 11:13am ET

Location: C110

Oral Poster Presenter(s)

Joshua M.V Mammen, MD PhD

Professor of Surgery
University of Nebraska Medical Center
Omaha, Nebraska, United States

Submitter(s)

Joshua M.V Mammen, MD PhD

Professor of Surgery
University of Nebraska Medical Center
Omaha, Nebraska, United States

Author(s)

Joshua M.V Mammen, MD PhD

Professor of Surgery
University of Nebraska Medical Center
Omaha, Nebraska, United States
Michael A. Henderson, n/a

Consultant
Division of Cancer Surgery, Peter MacCallum Cancer Centre
Melbourne, Victoria, United States
FW

Frances C. Wright, MD MEd

Surgical oncologist, Professor
Sunnybrook Health Sciences Centre, United States
Marc D. Moncrieff, MD FRCS(Plast.)

Professor of Plastic & Reconstructive Surgery
Norfolk & Norwich University Hospital
Norwich, United Kingdom
AS

Andrew Spillane, MBBS, MD, FRACS

Surgeon
Melanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia, Australia
David Gyorki, n/a

Consultant
Division of Cancer Surgery, Peter MacCallum Cancer Centre
Melbourne, Victoria, United States
RS

Robyn Saw, MBBS, FRACS, MS

Surgeon
Melanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia, United States
RO

Roger Olofsson Bagge, MD, PhD

Surgical oncologist
Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Gothenburg, Sweden
JD

Janet Dancey, MD

Professor
Queen's University, United States
KL

Katja Loewe, MSc

Research Manager
Melanoma and Skin Cancer Trials Ltd, United States
John Thompson, MBBS, MD, DSc, FRACS, FACS (Hon), FAHMS

Surgeon
Melanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia
North Sydney, New South Wales, Australia

Introduction:

International guidelines vary in recommendations for the width of excision for intermediate and thick primary cutaneous melanoma due to lack of high level evidence. An international randomized trial, MelMart-II, is comparing 1 cm v 2 cm margins for patients with pT2b to pT4b melanoma. Results of the trial will have implications for patient morbidity, QOL, and cost of care. Sample size calculations indicate a total study size of 2998 patients necessitating an international multicenter approach.

The aim of this report is to describe the development and enablers of the international collaborative effort for this study.

Methods: MelMarT-II study is an international randomized study funded initially by the Australian Government National Health and Medical Research Council in 2018.

Results:

As of September 2023 1573 patients have been recruited from 142 sites in 12 countries including US (102 sites 543 patients), Canada (10, 166) UK (19, 347) and Australia (6, 205).

Factors contributing to the success of this study include

1 Recognition by melanoma surgeons internationally of this crucial issue requiring a randomized trial

2 Existing personal and collaborative relationships fostered by previous melanoma trials (eg MSLT-I, II), previous exchange of trainees and major melanoma meetings facilitated the planning and participation in this study

3 Initial pilot study of 400 patients from Australia, US, UK, Canada and Sweden permitted refinement of study eligibility criteria and processes and collection of health economic and QOL data, justifying funding

4 Australian Government regulations permitted funding for central trial activities including data management and randomization etc but prohibited off shore capitation payments. This required multiple international funding agreements in participating countries with either national grant bodies including US National Cancer Institute, Cancer Clinical Trials Canada, National Institute for Health Research UK and individual hospitals / institutions including Sweden, New Zealand, Netherlands, Slovenia

5 The COVID pandemic created barriers that delayed uptake of the trial and mandated extensive use of international teleconferencing and brought forward the use of telehealth and online collection of QOL and health economics data by participants.

Conclusions:

The Mel-Mart-II study is currently recruiting strongly with no significant issues. The size of this study necessitated a multinational, multicenter approach and a unique funding model with national grant bodies responsible for each individual nation’s trial activities.

Learning Objectives:

Upon completion, participant will be able to describe a model to develop a international clinical trial with rapid accrual.
Upon completion, participant will be able to describe a model to develop a international clinical trial with funding sources that are local versus central.
Upon completion, participants will be able to describe the knowledge gap in margins needed to treat early stage melanoma.