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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Carla
Duarte
+61 (0)402 959 431
melmart@masc.org.au
Mrs
Jo
Cook
-
melmart2@nds.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Cutaneous melanoma
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Background and study aims
Melanoma accounts for the great majority of skin cancer deaths in the UK. Since the 1990s the diagnosis of melanoma has more than doubled. According to World Health Organisation statistics, the UK has one of the highest death rates from skin cancer in the world. In contrast to most other cancers, melanoma tends to affect much younger people, with nearly half the patients diagnosed at under 65 years old.
Melanoma has a tendency for recurring around the original biopsy (tissue sample) site in a very aggressive manner, making it a very challenging problem to treat when it occurs. To prevent local recurrence, the standard treatment has been to take a further safety margin of normal skin and soft tissue around the original melanoma biopsy site. This treatment is offered to every patient diagnosed with melanoma. Surprisingly, this margin of safety has yet to be standardised for melanoma, with a significant variety of excision margins being recommended in different countries (from 1 cm to 3 cm depending on the initial stage of the disease). Since melanoma commonly occurs in the head and neck region or on the limbs, the cosmetic and functional implications for patients with such large defects are substantial.
The rate of local recurrence for melanoma is quite low (2-8%) and, despite several large clinical trials, there is little evidence that performing such wide excisions changes recurrence rates or improves survival for our patients. Given that the overall 10-year survival for melanoma is now 90% internationally, with about 150,000 people in the UK currently living with the diagnosis, this has become a key survivorship issue for these patients.
The aim of this study is to find out whether a 1 cm excision margin is as safe as a 2 cm margin for high-risk melanoma of the skin. This study is designed to show that the risk of long-term pain associated with surgery can be halved and quality of life can be improved with a 1 cm margin due to reduced side effects and need for reconstructive surgery after treatment. This study will also evaluate the economic impact of safely using less surgery for the NHS and society in general.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current participant exclusion criteria as of 25/04/2025: 1. Uncertain diagnosis of melanoma i.e., so-called ‘melanocytic lesion of unknown malignant potential’.2. Patient has already undergone WLE at the site of the primary index lesion.3. Patient unable or ineligible to undergo staging SLNB of the primary index lesion.4. Perineural invasion or neurotropic melanoma: Neurotropism or perineural invasion in any type of melanoma is an exclusion. Perineural invasion does not include entrapment of nerves within the main primary tumour mass.5. Desmoplastic melanoma: with any patient where pathology determines melanoma as PURE desmoplastic (as per WHO definition of >90% desmoplasia), they are not eligible for this study. However, melanomas with less than 90% desmoplasia or mixed desmoplastic subtypes are eligible unless there is neurotropism present (perineural invasion)6. Microsatellitosis (a nest of metastatic tumour cells found to be growing away from the primary tumour) as per AJCC 8th edition definition is an exclusion.7. Subungual melanoma.8. Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.9. History of previous or concurrent (i.e., >1 primary melanoma) invasive melanoma.10. Melanoma located distal to the metacarpophalangeal joint; on the tip of the nose; the eyelids or on the ear; genitalia, perineum or anus; mucous membranes or internal viscera.11. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.12. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including -SLNB, of the index melanoma.13. Any additional solid tumour or hematologic malignancy during the past 5 years (with exception of non- melanoma skin cancers (T1 skin lesions of squamous cell carcinoma (SCCs), basal cell carcinoma (BCCs)), or uterine/cervical cancer).14. Melanoma-related operative procedures not corresponding to criteria described in the protocol.15. Planned adjuvant radiotherapy to the primary melanoma site after wide local excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study.16. History of organ transplantation.17. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at enrolment or within 6 months prior to enrolment.
Please note:1. Pregnancy is not a specific exclusion criterion for this trial, though it may not be clinically appropriate to perform a wide excision and SLNB until the pregnancy has been completed, which may exclude the patient due to violation of inclusion criterion 4.2. We would advise careful counselling of the patient prior to enrolment, which would include a discussion at the treating centre’s multidisciplinary team meeting or tumour board and the central trial office.
Previous participant exclusion criteria: 1. Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'2. Patient has already undergone wide local excision at the site of the primary index lesion3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion4. Desmoplastic or neurotropic melanoma5. Microsatellitosis as per AJCC 8th edition definition6. Subungual melanoma7. Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible8. History of previous or concurrent (i.e., second primary) invasive melanoma9. Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, genitalia, perineum or anus, mucous membranes or internal viscera10. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma11. Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including sentinel lymph node biopsy, of the index melanoma12. Any additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer13. Melanoma-related operative procedures not corresponding to criteria described in the protocol14. Planned adjuvant radiotherapy to the primary melanoma site after Wide Local Excision is not permitted as part of the protocol and any patients given this treatment would be excluded from the study15. History of organ transplantation16. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at enrolment or within 6 months prior to enrolment
Pregnancy is not a specific exclusion criterion for this trial, though it may not be clinically appropriate to perform a wide excision and sentinel node biopsy until the pregnancy has been completed, which is likely to exclude the patient due to violation of inclusion criterion 4. The researchers would advise careful counselling of the patient prior to enrolling the patient, which would include a discussion at the treating centre's multidisciplinary team meeting or tumour board. They would strongly advise contacting the central trial office to discuss the case prior to enrolling on the study.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mrs
Jo
Cook
-
melmart2@nds.ox.ac.uk
Ms
Carla
Duarte
+61 (0)402 959 431
melmart@masc.org.au
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Melanoma and Skin Cancer Trials Ltd; Norfolk and Norwich University Hospitals NHS Foundation Trust and funded by National Health and Medical Research Council; National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
