Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Narrow Excision Versus Wide Excision for Adults With Primary Invasive Cutaneous Melanomas
OHSU Knight Cancer Institute
1,000 participants
Dec 11, 2024
INTERVENTIONAL
Conditions
Summary
This clinical trial compares the effect of a narrow surgical excision (removal) to a wide excision for the treatment of adults with invasive cutaneous melanoma. Currently the standard of care is to take wide margins (boarder of healthy tissue surrounding the melanoma) when removing melanoma. Narrow margin excision removes a smaller amount of healthy tissue when surgically removing the melanoma. Narrow margin excision may be effective in removing the melanoma while also reducing surgical complications and improving quality of life for adults with invasive cutaneous melanoma.
Eligibility
Inclusion Criteria13
- Participants or legally authorized representatives (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
- Age ≥ 18 years; all biological gender identities and racial/ethnic groups will be included
- Participants must have histologically confirmed primary cutaneous melanoma. Acral melanomas are eligible.
- Participants must have one of the following:
- American Joint Committee on Cancer (AJCC) 8th Ed clinical stage IA disease with Breslow thickness \> 0.5 mm AND at least one high-risk feature (Mitotic rate ≥ 2/mm2, age ≤ 42, lymphovascular invasion, head/neck location)
- AJCC 8th Ed Clinical Stage IB melanoma
- If a melanoma is widely transected and the true Breslow depth is uncertain, then to be eligible for this trial, the melanoma must be re-biopsied to ascertain an accurate Breslow depth.
- The index melanoma must be classified as low risk on the Merlin Assay (SkylineDx)
- Study intervention (surgery) must be completed within 120 days of the original diagnostic biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Participants with a history of HIV infection are eligible
- Participants can speak, read and write in English or Spanish
Exclusion Criteria9
- Uncertain diagnosis of melanoma (i.e. severely dysplastic nevi, melanocytic lesion of unknown malignant potential, atypical intraepidermal melanocytic proliferations)
- The patient has already undergone wide local excision at the site of the primary index lesion
- The patient has a pure desmoplastic melanoma. A pure desmoplastic melanoma is defined as being \> 90% desmoplastic type. Melanomas with \< 90% desmoplastic type may be included in this trial
- Mucosal and ocular melanomas are also excluded, as these are approached differently for surgical excision
- Physical, clinical, radiographic, or pathologic evidence of satellite, in-transit, regional, or distant metastatic melanoma
- Participants with known or suspected cancer with regional or distant metastasis are excluded from this clinical trial because this trial is aimed at evaluating the control of localized disease
- The patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, including a sentinel lymph node biopsy, of the index melanoma
- Planned adjuvant radiotherapy to the primary melanoma site after excision
- Participant is unwilling or unable to comply with study procedures
Interventions
Undergo blood sample collection
Undergo narrow margin excision
Undergo wide margin excision
Ancillary studies
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06673095