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

Trial Details

NCT ID
NCT03860883
Phase
NA
Sponsor
Melanoma and Skin Cancer Trials Limited
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Wide Local Excision = 1cm Margin
  • Wide Local Excision = 2cm Margin
Locations (sample)
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Irvine, California, United States|33.66946,-117.82311

Key Eligibility Criteria

  • Patients may be included in the study if they meet ALL of the following criteria:
  • 1\. Patients must have a Stage II primary invasive cutaneous melanoma (pT2b-pT4b, AJCC 8th edition) with Breslow thickness \>1.0mm to 2.0mm; \>2.0m…
  • Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm or sole).
  • An uninterrupted 2cm margin must be technically feasible around biopsy scar or primary melanoma.

For full eligibility, visit ClinicalTrials.gov.

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