MelMarT - Melanoma Margins Trial - Pilot Study
Research type
Research Study
Full title
A Phase III, multicentre,multinational randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma. Pilot Study
IRAS ID
158807
Contact name
Marc Moncrieff
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
The standard treatment for people with early melanoma is surgical removal of the melanoma, which usually happens in 2 stages. First some tissue is taken to investigate whether the lesion is melanoma. Secondly, a wider area of healthy skin surrounding the original melanoma is removed to reduce the chance of the melanoma returning. Surgical margins vary worldwide, from 1cm to 3cm, resulting into large wounds from 2cm to 6cm across. Evidence from previous research suggests that a 1cm excision is enough to reduce the risk of the melanoma coming back in the same area. However, a trial is needed to prove this theory. This study aims to determine whether there is a difference in local recurrence rates and melanoma survival rates for patients treated with either a 1cm or 2cm excision margin for both intermediate & high-risk melanomas (greater than 1 mm in thickness). The study also aims to assess reduction of post-operative pain associated with surgery, as well as impact on quality of life, other side effects and economic impact on the health services and society in general. In the design, patients will be divided into two risk groups according to their melanoma thickness. Then, all patients will be randomised to either a 1cm or 2cm surgical margin in combination with a sentinel lymph node biopsy (to determine whether tumour cells have spread to the closest lymph node). To assess recurrence rates and melanoma survival rates, patients will undergo close follow up during 10 years. To assess pain, side effects and quality of life, patients will complete pain assessment scales and quality of life questionnaires.
We plan to undertake an initial pilot study to assess the feasibility of undertake the trial on a much larger scale. All patients enrolled in the pilot will be included in the final study.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1254
Date of REC Opinion
24 Nov 2014
REC opinion
Favourable Opinion