Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial

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 narrow vs wide excision. V. To compare surgical complication rates in patients treated with narrow vs wide excision. VI. To compare the frequency of complex reconstruction in patients treated with narrow vs wide excision. VII. To compare the final defect size in patients treated with narrow vs wide excision. VIII. To compare the number of operative/procedure days required to achieve negative margins. EXPLORATORY OBJECTIVE: I. To measure the T- and B-cell repertoires in patients with melanoma over time. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study. ARM II: Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 1 week, 3, 6, 12, 36, 48, and 60 months.