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

NCT02385214 | Active Not Recruiting DMC

• 1 other identifier: 03.12
• Study Type: interventional
• Target: 400
• Locations: 5 countries
• Sites: 20

Brief 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. 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

Conditions

Cutaneous Melanoma by AJCC V7 Stage

Keywords

Malignant; Melanoma; Cancer; Surgery

Outcome Measures

Primary Outcomes (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.

  0-120 months

Secondary Outcomes (6)

• Recurrence-Free Survival

  0-120 months

• QoL and neuropathic pain assessments Neuropathic Pain (PainDetect)

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

• Overall Survival

  0-120 Months

• Adverse events

  Within 1 year

• Surgery related adverse events

  Up to 30 days from randomisation

Study Arms (2)

Arm A Wide Local Excision = 1cm Margin

EXPERIMENTAL

ARM A: Experimental Arm Wide Local Excision = 1cm Margin + Sentinel Lymph Node Biopsy +/- Reconstruction

Procedure: Wide Local Excision = 1cm Margin

Arm B Wide Local Excision = 2cm Margin

ACTIVE COMPARATOR

ARM B:Control Arm Wide Local Excision = 2cm Margin + Sentinel Lymph Node Biopsy +/- Reconstruction

Procedure: Wide Local Excision = 2cm Margin

Interventions

Wide Local Excision = 1cm Margin PROCEDURE

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.

Arm A Wide Local Excision = 1cm Margin

Wide Local Excision = 2cm Margin PROCEDURE

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.

Arm B Wide Local Excision = 2cm Margin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Melanoma and Skin Cancer Trials Limited: lead
• Peter MacCallum Cancer Centre, Australia: collaborator
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Study Sites (20)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Melanoma Institute Australia - Poche Centre

North Sydney, New South Wales, 2060, Australia

Location

Gold Coast Melanom Clinic

Coolangatta, Queensland, 4225, Australia

Location

Peter MacCallum Cancer Centre Division of Cancer Surgery

Melbourne, Victoria, 3002, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Sunnybrook Health Sciences Centre

Toronto, Canada

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Hull and East Yorkshire Hospitals NHS Trust

Hull, England, HU16 5JQ, United Kingdom

Location

Guy's and St Thomas' Hospital NHS Trust

London, England, SE1 7EH, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, England, M20 4BX, United Kingdom

Location

Mid Essex Hospital Services NHS Trust

Broomfield, Essex, CM1 7ET, United Kingdom

Location

St Helens & Knowsley NHS Trust

St Helens, Mersyside, L35 5DR, United Kingdom

Location

Oxford University Hospitals NHS Trust

Headington, Oxford, OX3 9DU, United Kingdom

Location

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

St. James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36821575 DERIVED

Related Links

• MASC Trials-Closed to recruitment page

MeSH Terms

Conditions

Melanoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marc Moncrieff

  Norfolk & Norwich University Hospital

  PRINCIPAL INVESTIGATOR

• Michael Henderson

  Peter MacCallum Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: March 11, 2015
• Study Start: January 3, 2015
• Primary Completion: August 4, 2016
• Study Completion (Estimated): August 5, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

CA (1); US (1); GB (13); AU (4); SE (1)