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
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.
Description
PRIMARY OBJECTIVE: I. To compare the 3-year local recurrence-free survival rates (RFS) in melanoma patients treated with narrow excision versus (vs) wide excision. SECONDARY OBJECTIVES: I. To measure the 3-, 5-year Regional (nodal) disease-free survival (DFS) in melanoma patients treated with active nodal surveillance. II. To compare 5-year local recurrence-free survival in patients treated with narrow vs wide excision. III. To compare 5-year Melanoma Specific Survival (MSS) in patients treated with narrow vs wide excision. IV. To compare the quality of life in patients treated with narr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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/…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureExcision
Undergo narrow margin excision
- ProcedureExcision
Undergo wide margin excision
- OtherSurvey Administration
Ancillary studies
Location
- OHSU Knight Cancer InstitutePortland, Oregon