MelMarT-II Trial to determine optimal surgical excision margin

March 4, 2022

For high-risk melanoma patients undergoing excision surgery, their doctor’s decision to use either a 1cm or 2cm excision margin could have a dramatic impact on their quality of life and survival.

A larger excision margin for melanomas on the face could lead to disfigurement, or reduced mobility for surgeries on the hands of feet. But if the excision margin is too small, the melanoma could return and metastasise.

Currently there is no high-quality evidence or consensus in the medical community about the optimal melanoma excision margin size for high-risk primary cutaneous melanoma.

A world-wide clinical trial is now hoping to resolve this issue by investigating whether there is a difference in disease-free survival for patients treated with either a 1cm or 2cm excision margin for stage II primary cutaneous melanoma.

Coordinated by Melanoma and Skin Cancer Trials Ltd, the phase III randomised controlled surgical trial is located across 28 sites in Australia, New Zealand, United Kingdom, USA, Canada, The Netherlands and Sweden. Plans for establishing more trial sites are underway, including several sites in Ireland and Slovenia.

The New Zealand trial site is at the North Shore Hospital, Auckland, and Mr Richard Martin is the site’s Principal Investigator. As of 1 February 2022, this site had enrolled five patients in the MelMarT-II trial.

Trial Co-Chief Investigator Prof Michael Henderson from the Peter MacCallum Cancer Centre in Melbourne said the evidence provided by this internationally recognised trial would advance clinical practice for melanoma in New Zealand and internationally.

“It is expected that the MelMarT-II trial results will lead to lower morbidity and guide the management of patients with high-risk primary cutaneous melanoma,” Prof Henderson said.

“When evaluating the results of this large study, we will consider the disease-free survival rates, quality of life and associated healthcare costs.”

“A clinical trial of this size will generate sufficient statistical power to clearly determine whether there is a difference for patients treated with either a 1cm or 2cm excision margin for stage II primary cutaneous melanoma,” he added.

The trial started in January 2020 and is scheduled to finish in December 2023, however the pandemic has slowed enrolment numbers so the trial may be extended. Before commencing the MelMarT-II trial, a pilot study with 400 patients was conducted to test the feasibility of the trial protocol.

Read more information about the MelMarT-II Trial.