Comparing narrow and wide surgical excision for melanoma treatment
ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Narrow Excision Versus Wide Excision for Adults With Primary Invasive Cutaneous Melanomas
This study is testing whether a narrow or wide surgical cut is better for treating melanoma in adults and helping them stay free of the disease for three years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06673095 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of narrow surgical excision compared to wide excision in adults with invasive cutaneous melanoma. The primary objective is to compare the 3-year local recurrence-free survival rates between the two surgical approaches. Secondary objectives include assessing regional disease-free survival, melanoma-specific survival, quality of life, surgical complication rates, and the size of surgical defects. Patients will be randomized into two groups, one receiving narrow excision and the other wide excision, with follow-up assessments conducted post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed clinical stage IA or IB cutaneous melanoma.
Not a fit: Patients with melanoma that does not meet the specified staging criteria or those with acral melanomas that do not qualify may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive surgical options for melanoma patients, potentially reducing complications and improving quality of life.
How similar studies have performed: Previous studies have shown promising results with similar surgical approaches, suggesting that narrow excision may be a viable alternative to wide excision.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Where this trial is running
Portland, Oregon
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Wesley Yu — OHSU Knight Cancer Institute
- Study coordinator: Wesley Yu, M.D.
- Email: yuwe@ohsu.edu
- Phone: 503-418-9386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.