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  • Presentation

The Iceman Trial: Randomized Comparison of Mohs, Staged Excision, and Wide Excision for Early-Stage Melanoma

Description

The speaker reviews current melanoma surgery guidelines, noting that Mohs and staged excision are selectively used for melanoma in situ and some minimally invasive melanomas in tissue-sparing or anatomically constrained sites, but that prospective evidence comparing these techniques to standard wide excision has been lacking. They emphasize that existing studies are mostly retrospective and often confounded by differences in patient and tumor risk, making comparisons unreliable. To address this gap, the group initially developed the CAKE trial concept and, after funding challenges, launched the Iceman trial, a multi-site randomized study. Iceman enrolls patients with early-stage, low-risk melanomas (T1A high-risk, T1B, and T2A) who also have a low-risk Merlin test result, and randomizes them to either standard wide excision or narrow excision/complete margin control depending on tumor location. The trial’s main endpoint is three-year local recurrence-free survival, with secondary outcomes including regional disease-free survival, melanoma-specific survival, quality of life, and complications. Recruitment has begun at several centers, with a goal of about 1,000 patients, and the speaker is optimistic that the study will finally provide rigorous evidence on both margin width and the value of comprehensive margin control in early-stage melanoma.

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Conclusions

  • Current guidelines still do not recommend Mohs micrographic surgery for primary treatment of invasive cutaneous melanoma when standard clinical margins can be obtained, but they allow selective use for melanoma in situ and anatomically constrained sites.
  • The evidence base for Mohs and staged excision in melanoma is largely retrospective, with no prospective comparisons to standard excision, so claims of superiority remain unproven.
  • Reported survival advantages for Mohs over wide excision likely reflect selection bias and confounding rather than a true biological treatment effect, because the compared patient groups are not equivalent.
  • There is a strong rationale to study whether complete margin control improves local recurrence outcomes, but the key unanswered question is whether it is actually better than standard wide excision in appropriately selected early melanomas.
  • The ICEMAN trial is designed to provide the first randomized evidence comparing narrow excision or complete margin control with standard wide excision in low-risk stage I melanoma.
  • By using the Merlin CP-GEP test to select lower-risk patients, the trial also aims to test whether sentinel lymph node biopsy can be safely omitted in this group.
  • If successful, the study could establish whether some early melanomas can be treated safely with smaller-than-standard margins without worsening recurrence or survival outcomes.
  • The most important outcome the field is waiting for is whether localized melanoma can be managed with less extensive surgery while preserving local control, quality of life, and complication rates.
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