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Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

NCT03860883 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2998

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 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.

Conditions

  • Cutaneous Melanoma, Stage II

Interventions

PROCEDURE

Wide Local Excision = 1cm Margin

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.

PROCEDURE

Wide Local Excision = 2cm Margin

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.

Sponsors & Collaborators

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Cancer Trials Ireland

    collaborator NETWORK

  • Zuyderland Medical Centre

    collaborator OTHER

  • Melanoma and Skin Cancer Trials Limited

    lead OTHER

Principal Investigators

  • Michael Henderson · Peter MacCallum Cancer Centre, Australia

  • Marc Moncrieff · Norfolk & Norwich University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2029-12-31
Completion
2034-12-31

Countries

  • United States
  • Australia
  • Canada
  • Ireland
  • Italy
  • Netherlands
  • New Zealand
  • Slovenia
  • 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 NCT03860883 on ClinicalTrials.gov