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Active, not recruiting Not applicable

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

NCT02385214 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2015-01-03
Last updated
2024-11-27

Condition(s) studied

Cutaneous Melanoma by AJCC V7 Stage

Investigational drug(s) / intervention(s)

Wide Local Excision = 1cm MarginWide Local Excision = 2cm Margin

Wide Local Excision = 1cm Margin: 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 Margin: 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 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. 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. 3. Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole). 4. An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma. 5. Randomisation and the primary study intervention, including staging sentinel node biopsy, must be completed by 120 days of original diagnosis. 6. Patients must be 18 years or older at time of consent. 7. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan. 8. Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI. 9. Patients must have an ECOG performance score between 0 and 1. 10. 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. 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 lesion. 3. Patient unable or ineligible to undergo staging sentinel lymph node biopsy of the primary index lesion. 4. Desmoplastic or neurotropic melanoma. 5. Microsatellitosis as per AJCC 2009 definition 6. Subungual melanoma 7. 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. 8. History of previous or concurrent (i.e., second primary) invasive melanoma. 9. Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera. 10. Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma. 11. 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. 12. 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. 13. Melanoma-related operative procedures not corresponding to criteria described in the protocol. 14. 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. 15. History of organ transplantation. 16. Oral or parenteral immunosuppressive agents (not topical or inhaled steroids) at any time during study participation or within 6 months prior to enrolment.

Primary outcome measure(s)

  • Local Melanoma Recurrence (Melanoma Specific Survival) — 0-120 months
    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.

Trial sites (20)

FacilityCityRegionStatus
Thomas Jefferson University Hospital Philadelphia Pennsylvania
Melanoma Institute Australia - Poche Centre North Sydney New South Wales
Gold Coast Melanom Clinic Coolangatta Queensland
Peter MacCallum Cancer Centre Division of Cancer Surgery Melbourne Victoria
Alfred Hospital Melbourne Victoria
Sunnybrook Health Sciences Centre Toronto Canada
Sahlgrenska University Hospital Gothenburg Sweden
Hull and East Yorkshire Hospitals NHS Trust Hull England
Guy's and St Thomas' Hospital NHS Trust London England
The Christie NHS Foundation Trust Manchester England
Mid Essex Hospital Services NHS Trust Broomfield Essex
St Helens & Knowsley NHS Trust St Helens Mersyside
Oxford University Hospitals NHS Trust Headington Oxford
North Bristol NHS Trust Bristol United Kingdom
Cambridge University Hospitals NHS Foundation Trust Cambridge United Kingdom
Royal Devon and Exeter NHS Foundation Trust Exeter United Kingdom
St. James University Hospital Leeds United Kingdom
Royal Free London NHS Foundation Trust London United Kingdom
Imperial College Healthcare NHS Trust London United Kingdom
Norfolk and Norwich University Hospital Norwich United Kingdom

More Melanoma and Skin Cancer Trials Limited trials in Sweden

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02385214 on ClinicalTrials.gov ↗ ← All trials in Sweden