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Cutaneous Melanoma by AJCC V7 StageMelMarTNCT02385214

MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

A study testing Wide Local Excision = 1cm Margin and Wide Local Excision = 2cm Margin in people with Cutaneous Melanoma by AJCC V7 Stage, run by Melanoma and Skin Cancer Trials Limited at 20 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cutaneous Melanoma by AJCC V7 Stage
What is being tested?
Wide Local Excision = 1cm Margin and Wide Local Excision = 2cm Margin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
20 sitesin 5 countries
Study dates
3 Jan 2015to 5 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a primary invasive cutaneous melanoma of Breslow thickness greater than 1 millimetre as determined by diagnostic biopsy (narrow excision, incision or punch biopsy) and subsequent histopathological analysis.
  • Patients must have had the invasive primary completely excised, including any in situ component but excluding melanocytic atypia, with a narrow margin, either in one stage or more than one stage in the case where an incision or punch biopsy has previously been performed. This information, including measured margins of lateral and deep clearance must be documented on the pathology report.
  • Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole).
  • An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.
  • Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed by 120 days of original diagnosis.
  • Patients must be 18 years or older at time of consent.
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  • Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan.
  • Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
  • Patients must have an ECOG performance score between 0 and 1.
  • 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 (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrence), and
  • The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.

Who cannot join

  • Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.
  • Patient has already undergone wide local excision at the site of the primary index lesion.
  • Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion.
  • Desmoplastic or neurotropic melanoma.
  • Microsatellitosis as per AJCC 2009 definition
  • Subungual melanoma
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  • 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.
  • History of previous or concurrent (i.e., second primary) invasive melanoma.
  • Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera.
  • Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma.
  • 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 melanoma.
  • 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 cancer.
  • Melanoma-related operative procedures not corresponding to criteria described in the protocol.
  • 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.
  • History of organ transplantation.
  • Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrolment.

Trial locations and contacts

20 sites in 5 countries.

20 sites in 5 countries

United Kingdom13 sites

  • North Bristol NHS Trust

    Bristol, BS10 5NB

  • Mid Essex Hospital Services NHS Trust

    Broomfield, Essex, CM1 7ET

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • Oxford University Hospitals NHS Trust

    Headington, Oxford, OX3 9DU

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, England, HU16 5JQ

  • St. James University Hospital

    Leeds, LS9 7TF

  • Guy's and St Thomas' Hospital NHS Trust

    London, England, SE1 7EH

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • Imperial College Healthcare NHS Trust

    London

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY

  • St Helens & Knowsley NHS Trust

    St Helens, Mersyside, L35 5DR

Other trials in United Kingdom

Australia4 sites

  • Gold Coast Melanom Clinic

    Coolangatta, Queensland, 4225

  • Peter MacCallum Cancer Centre Division of Cancer Surgery

    Melbourne, Victoria, 3002

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Melanoma Institute Australia - Poche Centre

    North Sydney, New South Wales, 2060

Other trials in Australia

United States1 site

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

Other trials in United States

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto

Other trials in Canada

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg

Other trials in Sweden

About this study

Official title: A Phase III, Multi-centre, Multi-national Randomised Control Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma

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 a primary invasive cutaneous melanomas >=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients

Read the detailed description

This study will determine whether there is a difference in local recurrence rates and melanoma survival rates for patients treated with either a 1cm excision margin or 2cm margin for both intermediate \& high risk melanomas. 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. This study is designed to show that the risk of long-term pain associated with surgery can be halved. If the study shows no risk of the 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.

Being tested
Wide Local Excision = 1cm Margin, Wide Local Excision = 2cm Margin
Keywords
Malignant, Melanoma, Cancer, Surgery
Medical subject headings
Melanoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wide Local Excision = 1cm MarginProcedure or surgery

    A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.

  • Wide Local Excision = 2cm MarginProcedure or surgery

    A wide local excision involves removing an extra "safety margin" of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery.

Study groups in NCT02385214
Study groupRoleWhat they receive
Arm A Wide Local Excision = 1cm MarginExperimentalARM A: Experimental Arm Wide Local Excision = 1cm Margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Receives: Procedure: Wide Local Excision = 1cm Margin
Arm B Wide Local Excision = 2cm MarginActive comparatorARM B:Control Arm Wide Local Excision = 2cm Margin + Sentinel Lymph Node Biopsy +/- Reconstruction
Receives: Procedure: Wide Local Excision = 2cm Margin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local Melanoma Recurrence (Melanoma Specific Survival)

    Time from randomisation to clinically, histologically or radiologically confirmed local recurrence of melanoma including satellite lesions and in transit metastases to regional draining lymph nodes.

    Measured: 0-120 months

Secondary outcomes (6)

  1. Recurrence-Free Survival

    Time from randomisation to any clinical, histological or radiologically confirmed melanoma recurrence or death from any cause.

    Measured: 0-120 months

  2. QoL and neuropathic pain assessments Neuropathic Pain (PainDetect)

    Quality of Life

    Measured: Baseline, 3, 6 12, 24 & 60 months.

  3. Overall Survival

    Time from randomisation to death from any cause.

    Measured: 0-120 Months

  4. Adverse events

    An Adverse Event (AE) is any untoward medical occurrence in a participant administered a treatment which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the treatment timing, whether or not considered related to the treatment. An AE is any adverse change (developing or worsening) from the participant's pre-treatment condition, including intercurrent illness.

    AEs and any pre-existing medical conditions will be recorded at the Baseline assessment and routinely at Follow Up, until the participant completes the study, withdraws or dies.

    Measured: Within 1 year

  5. Surgery related adverse events

    The following surgical adverse events will be recorded from the time of trial treatment to 30 days following the wide excision (inclusive):

    • wound separation
    • seroma/haematoma at wide local excision site
    • haemorrhage
    • infection
    • skin graft failure
    • necrosis of flap used for reconstruction
    • deep venous thrombosis
    • urinary tract infection
    • pneumonia
    • cardiac complications

    Measured: Up to 30 days from randomisation

  6. Health System Resource Use

    All hospitalisations and other interventions will be captured in order to measure resource use.

    Measured: Baseline, 3, 6, 12, 24 and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Study start3 Jan 2015
  3. Primary completion4 Aug 2016
  4. Study completion5 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385214
Sponsor's protocol ID
03.12
Acronym
MelMarT
Status last verified
Nov 2024
First submitted
13 Jun 2014
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Temple-Oberle C, Nicholas C, Rojas-Garcia P. Current Controversies in Melanoma Treatment. Plast Reconstr Surg. 2023 Mar 1;151(3):495e-505e. doi: 10.1097/PRS.0000000000009936. Epub 2023 Feb 23.

    PubMed 36821575

Questions about this trial

What is this clinical trial studying?

A study testing Wide Local Excision = 1cm Margin and Wide Local Excision = 2cm Margin in people with Cutaneous Melanoma by AJCC V7 Stage, run by Melanoma and Skin Cancer Trials Limited at 20 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United Kingdom, Australia, United States, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Melanoma Recurrence (Melanoma Specific Survival) (time frame: 0-120 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02385214, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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