About this trial
This study will determine whether there is a difference in disease free survival for patients treated with either a 1cm excision margin or 2cm margin for clinical stage II (pT2b-pT4b) primary cutaneous melanoma (AJCC 8th edition, Table 1). The study is designed to be able to prove or disprove that there is no difference in risk of melanoma recurrence between the two groups of patients. This study is designed to show that the risk of long-term pain associated with surgery can be reduced. If the study achieves its primary objective and demonstrates safety with a narrower margin, 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.
It is expected that successful completion of this study will define the appropriate management of Stage II primary cutaneous melanoma (pT2b-pT4b) for Australia and the international melanoma community.
Patient Profile
To participate in the trial, participants must be 18 years or older, presenting with an ECOG of 0-1 and have been diagnosed with primary cutaneous melanoma. Randomisation and treatment must be performed within 120 days of diagnosis and participants must have no previous malignancy or primary except low-risk non-melanoma skin cancer, unless in remission and greater than five years since diagnosis.
Where’s this trial being run?
Cork University Hospital, St James’s Hospital, and Mater Misericordiae University Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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QuestionsSummary Data
| Name: | MelMarT-II |
|---|---|
| Number: | 20-37 |
| Full Title: | 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) |
| Principal Investigator: | Shirley Potter (CI, Ireland); Marlese Dempsey- PI @ SJH, Prof Jim Clover- PI @ CUH |
|---|---|
| Type: | Collaborative |
| Sponsor: | MASC (Melanoma and Skin Cancer Trials Limited) |
| Recruitment Started: |
Global: 17-Dec-2019 Ireland: 01-March-2024 |
| Global Recruitment Target: | 2998 |
|---|---|
| Ireland Recruitment Target: | 120 |