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Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

Sponsor: Melanoma and Skin Cancer Trials Limited

NCT ID: NCT03860883

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Wide Local Excision = 1cm Margin (procedure), Wide Local Excision = 2cm Margin (procedure)
How long the study runs
Study runs about 180 months (dates as stated)
About the drug or intervention
Wide Local Excision = 1cm Margin — procedure: A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed. · Wide Local Excision = 2cm Margin — procedure: A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.
Patient visit burden
Not specified by the sponsor

In plain English

This trial is for adults with stage II melanoma (a type of skin cancer) of the skin. It compares two widths of surgery to remove the melanoma: a 1 centimetre margin versus a 2 centimetre margin of healthy skin around it.

Who can take part

  • Adults aged 18 or over who can give informed consent and follow the treatment and follow-up plan
  • Have a stage II primary invasive melanoma of the skin, confirmed by a biopsy, with specific thickness levels set out by the trial
  • The melanoma is on the skin, such as the head, neck, trunk, limb, scalp, palm or sole
  • It must be possible to remove an unbroken 2 centimetre margin of skin around the melanoma or biopsy scar
  • Surgery must happen within 120 days of diagnosis and within 28 days of joining the trial
  • A life expectancy of at least 5 years (not counting the melanoma), as judged by the lead researcher
  • Fully active or able to carry out light activity only (a performance score of 0 or 1)
  • People who have had another cancer before may join if they had treatment aiming to cure it, have had no signs of it returning for at least 5 years (or it was successfully treated womb, cervix, or non-melanoma skin cancer), and their doctor judges a low risk of it returning

Who may not be able to

  • An uncertain diagnosis of melanoma
  • Already had a wide local excision (surgery to remove the melanoma with a margin) at the site
  • Unable to have a sentinel lymph node biopsy (a test on the nearby lymph nodes)
  • The melanoma has grown into or around nerves, or is a pure desmoplastic melanoma
  • Small clusters of tumour cells growing away from the main melanoma (microsatellitosis)
  • Melanoma under a fingernail or toenail
  • Already had skin flap repair surgery at the site where the margin cannot be measured accurately
  • More than one invasive melanoma, now or in the past
  • Melanoma in certain places, such as beyond the knuckles, on the nose tip, eyelids, ears, genitals, private areas, or moist internal linings and organs
  • Any sign that the melanoma has spread
  • Already had surgery on the nearby lymph nodes for this melanoma
  • Another cancer in the past 5 years (except some non-melanoma skin cancers and womb or cervical cancer)
  • Melanoma operations that do not match the trial plan, or planned radiotherapy to the melanoma site after surgery
  • Past organ transplant
  • Taking medicines that suppress the immune system by mouth or injection (tablets, injections or drips), now or in the last 6 months. Creams or inhalers for this are allowed

What taking part involves

  • • Surgery to remove the melanoma, with either a 1 centimetre or a 2 centimetre margin of healthy skin around it
  • • A sentinel lymph node biopsy (removing and testing one or more nearby lymph nodes) done on the same day as the surgery
  • • You are placed at random into one of the two margin groups

Time commitment: Not stated — ask the trial team. Surgery must take place within 28 days of joining the trial, and a follow-up plan is part of taking part.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
2,998
Started
2019-12-17
Last checked
2024-11

Plain English Summary

What is this study?

  • • Testing a new treatment for cutaneous melanoma, stage ii
  • • NA - 2,998 participants
  • • Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with cutaneous melanoma, stage ii

Where?

  • • Edgbaston - University Hospitals Birmingham NHS Foundation Trust
  • • Truro - Royal Cornwall Hospital NHS Trust
  • • Hull - Hull University Teaching Hospitals NHS Trust
  • • Westcliff-on-Sea - MID & South Essex NHS Foundation Trust
  • • +16 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

More detail

This study will determine whether there is a difference in disease-free survival rates for patients with primary cutaneous melanoma with Breslow thickness \> 2mm or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or 2cm margin. The study is designed to be able to prove or disprove that there is no difference in risk of the tumour recurring around the scar or anywhere else in the body between the two groups of patients. If the study shows no risk of tumour recurrence 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.

Cutaneous Melanoma, Stage II

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

met

Treatment history

Treatments you must have had:

  • ✓ a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole)
  • ✓ an ECOG performance score between 0 and 1 at screening

What the study is looking for

  • ✓Patients may be included in the study if they meet ALL of the following criteria:
  • ✓Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).
  • ✓An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
  • ✓Patients must be 18 years or older at time of consent.
  • ✓Patient must be able to give agreement to take part and comply with the treatment protocol and follow up plan.

Who cannot take part

  • ✗Patients will be excluded from the study for ANY of the following reasons:
  • ✗Uncertain diagnosis of melanoma i.e., so-called 'melanocytic lesion of unknown malignant potential'.
  • ✗Patient has already undergone WLE at the site of the primary index lesion.
  • ✗Patient unable or ineligible to undergo staging SLNB of the primary index lesion.
  • ✗Microsatellitosis (a nest of that has spread tumour cells found to be growing away from the primary tumour) as per AJCC...
See the full criteria
Inclusion Criteria: Patients may be included in the study if they meet ALL of the following criteria: 1. 1\. Patients must have a Stage II primary invasive cutaneous melanoma (pT2b-pT4b, AJCC 8th edition) with Breslow thickness \>1.0mm to 2.0mm; \>2.0mm to 4.0mm or \>4.0mm with ulceration, or \>2.0mm to 4.0mm; or \>4.0mm without ulceration (Table 1) as determined by diagnostic biopsy (narrow excision, incision, shave or punch biopsy) and subsequent histopathological analysis. 2. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole). 3. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma. 4. 4\. Surgical intervention (which refers to the staging -SLNB and WLE as these are both to be done on the same day) must be completed within 120 days of the original diagnosis. Surgical intervention must also be performed within 28 days of randomisation. 5. Patients must be 18 years or older at time of consent. 6. Patient must be able to give informed consent and comply with the treatment protocol and follow up plan. 7. Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI. 8. Patients must have an ECOG performance score between 0 and 1 at screening. 9. A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented: * The patient has undergone potentially curative therapy for all prior malignancies, * There has been no evidence of recurrence of any prior malignancies for at least FIVE years (with the exception of successfully treated uterine/cervical or non-melanoma skin cancers (SCCs/BCCs) with no evidence of recurrence), and * The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies. Exclusion Criteria: Patients will be excluded from the study for ANY of the following reasons: 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. 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. We 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. We would strongly advise contacting the central trial office to discuss the case prior to enrolling on the study.

Where Is This Study? (20 UK sites)

University Hospitals Birmingham NHS Foundation Trust

Edgbaston B15 2TH, United Kingdom

Recruiting
Site contact (verified)
Agustin Martin-ClavijoPrincipal Investigator
Agustin Martin-ClavijoAgustin.Martin-Clavijo@uhb.nhs.uk

Royal Cornwall Hospital NHS Trust

Truro TR1 3LJ, United Kingdom

Recruiting
Site contact (verified)
Polly KingPrincipal Investigator

Hull University Teaching Hospitals NHS Trust

Hull HU3 2JZ, United Kingdom

Recruiting
Site contact (verified)
Paolo MatteucciPrincipal Investigator

MID & South Essex NHS Foundation Trust

Westcliff-on-Sea SS0 0RY, United Kingdom

Recruiting
Site contact (verified)
Peter DziewulskiPrincipal Investigator
Prof Peter Dziewulskipeter.dziewulski1@nhs.net

Lancashire Teaching Hospitals NHS Foundation Trust

Preston PR2 9HT, United Kingdom

Recruiting
Site contact (verified)
Richard WainPrincipal Investigator

Oxford University Hospitals NHS Foundation Trust

Headington OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
oliver cassellPrincipal Investigator

Imperial College Healthcare NHS Trust

London W2 1NY, United Kingdom

Recruiting
Site contact (verified)
Jonathon DunnePrincipal Investigator

Queen Victoria Hospital NHS Foundation Trust

East Grinstead RH19 3DZ, United Kingdom

Recruiting
Site contact (verified)
Siva KumarPrincipal Investigator

North Bristol NHS Trust

Bristol BS10 5NB, United Kingdom

Recruiting
Site contact (verified)
Ewan Wilson, MrEwan.Wilson@nbt.nhs.uk

Cambridge University Hospitals NHS Foundation Trust

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Amit RoshanPrincipal Investigator

The Leeds Teaching Hospitals NHS Trust

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Howard Peach, Mrh.peach@nhs.net

St. Helens & Knowsley Teaching Hospitals NHS Trust

Liverpool, United Kingdom

Recruiting
Site contact (verified)
Rowan Pritchard Jones, ProfRowan.PritchardJones@sthk.nhs.uk

Royal Free London NHS Foundation Trust

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)
Steven HamiltonPrincipal Investigator

Guy's and St Thomas's NHS Foundation Trust, of St Thomas' Hospital

London SE1 7EH, United Kingdom

Recruiting
Site contact (verified)

St George's University Hospitals NHS Foundation Trust

London SW17 0QT, United Kingdom

Recruiting
Site contact (verified)

The Royal Marsden Hospital NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Myles SmithPrincipal Investigator

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Deemesh OuditPrincipal Investigator

South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital

Middlesbrough TS4 3BW, United Kingdom

Recruiting
Site contact (verified)
Oliver Bassett, Mro.bassett@nhs.net

Norfolk and Norwich University Hospital NHS Trust

Norwich NR47UY, United Kingdom

Recruiting
Site contact (verified)
Professor Marc MoncrieffPrincipal Investigator

Nottingham University Hospitals, NHS Trust, Trust HQ, City Hospital

Nottingham NG5 1PB, United Kingdom

Recruiting
Site contact (verified)
Mr Jonathon PollockJonathan.Pollock@nuh.nhs.uk

How to Get in Touch

Melanoma and Skin Cancer Trials Coordinator

Sponsor contact

CONTACT

+61 3 9903 9022 melmart@masc.org.au
Data sourced from ClinicalTrials.gov · Last verified: 2024-11