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

NCT02385214 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-11-27

No results posted yet for this 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

Conditions

  • Cutaneous Melanoma by AJCC V7 Stage

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    collaborator OTHER

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Melanoma and Skin Cancer Trials Limited

    lead OTHER

Principal Investigators

  • Marc Moncrieff · Norfolk & Norwich University Hospital

  • Michael Henderson · Peter MacCallum Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-03
Primary Completion
2016-08-04
Completion
2026-08-05

Countries

  • United States
  • Australia
  • Canada
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385214 on ClinicalTrials.gov