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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Undergo blood sample collection
Undergo narrow margin excision
Undergo wide margin excision
Ancillary studies
OHSU Knight Cancer Institute
Portland, Oregon, United States
RECRUITINGLocal recurrence rate
Defined as average rate at which cancer returns to same location as the original tumor.
Time frame: From randomization to end of year 3
Regional (nodal) disease-free survival
Average number of participants who are experiencing regional disease-free survival at 3 and 5 years.
Time frame: From randomization to end of year 5
Local recurrence-free survival
The average length of time (in months) from the date of randomization to local recurrence.
Time frame: From randomization to end of year 5
Melanoma-specific survival
The average length of time (in months) from date of randomization to death.
Time frame: From randomization to end of year 5
Postoperative pain
Measured by numeric rating scale (0-10).
Time frame: Up to 30 days after surgery
Quality of life
Quality of life score as measured by either the Facial Appearance, Quality of Life, and Experience Questionnaire (FACE-Q) score in patients with melanoma on the face or the Functional Assessment of Cancer Therapy - Melanoma (FACT-M) score for patients with melanoma elsewhere on the body. FACT-M is a tool for measuring health-related quality of life in patients with melanoma. It has 51 items, Scores range from 0 to 120 with higher score indicating better quality of life (QOL). FACE-Q includes 5 independently functioning scales and 2 checklists that measure outcomes important to patients from their perspective.
Time frame: Up to postoperative day 90
Surgical complication rate
Defined as the proportion of patients experiencing a surgical complication.
Time frame: Up to postoperative day 90
Frequency of complex reconstruction
Defined as the proportion of patients receiving any flap or graft reconstruction.
Time frame: Immediately after surgery
Defect size
The size of the defect is measured as the greatest dimension of the final wound multiplied by the dimension perpendicular to the greatest dimension.
Time frame: Immediately after surgery
Number of operative/procedure days
Will compare the number of operative/procedure days required to achieve negative margins. Will be reported and compared separately (Mohs surgery, narrow excision with permanent sections, wide excision with permanent sections, and slow Mohs).
Time frame: Up to postoperative day 90
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