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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (20 UK sites)
University Hospitals Birmingham NHS Foundation Trust
Edgbaston B15 2TH, United Kingdom
Royal Cornwall Hospital NHS Trust
Truro TR1 3LJ, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull HU3 2JZ, United Kingdom
MID & South Essex NHS Foundation Trust
Westcliff-on-Sea SS0 0RY, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston PR2 9HT, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Headington OX3 9DU, United Kingdom
Imperial College Healthcare NHS Trust
London W2 1NY, United Kingdom
Queen Victoria Hospital NHS Foundation Trust
East Grinstead RH19 3DZ, United Kingdom
North Bristol NHS Trust
Bristol BS10 5NB, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds LS9 7TF, United Kingdom
St. Helens & Knowsley Teaching Hospitals NHS Trust
Liverpool, United Kingdom
Royal Free London NHS Foundation Trust
London NW3 2QG, United Kingdom
Guy's and St Thomas's NHS Foundation Trust, of St Thomas' Hospital
London SE1 7EH, United Kingdom
St George's University Hospitals NHS Foundation Trust
London SW17 0QT, United Kingdom
The Royal Marsden Hospital NHS Foundation Trust
London SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital
Middlesbrough TS4 3BW, United Kingdom
Norfolk and Norwich University Hospital NHS Trust
Norwich NR47UY, United Kingdom
Nottingham University Hospitals, NHS Trust, Trust HQ, City Hospital
Nottingham NG5 1PB, United Kingdom
How to Get in Touch
Melanoma and Skin Cancer Trials Coordinator
Sponsor contactCONTACT
