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

Not Applicable

Recruiting

• Conditions: Clinical Stage IA Cutaneous Melanoma AJCC v8; Clinical Stage IB Cutaneous Melanoma AJCC v8; Clinical Stage IIA Cutaneous Melanoma AJCC v8

• Registration Number: NCT06673095
• Lead Sponsor: OHSU Knight Cancer Institute

Brief 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.

Detailed Description

PRIMARY OBJECTIVE:

I. To compare the 3-year (y) local recurrence- rates 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 3-, 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.

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 Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Status Verified: 2024-12
• Study Start: 2024-12-11
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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. Both men and women and members of all races and ethnic groups will be included

• Participants must have histologically confirmed primary cutaneous melanoma. Acral melanomas are eligible. Mucosal and ocular melanomas are excluded. Pure desmoplastic melanomas (> 90% desmoplastic) are also excluded

• 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

  • AJCC 8th Ed Clinical Stage IIA 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. If a melanoma is narrowly transected and the treatment team feels that the biopsy is an accurate reflection of true Breslow depth, then rebiopsy is not necessary

• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local recurrence rate	From randomization to end of year 3	Defined as average rate at which cancer returns to same location as the original tumor.

Secondary Outcome Measures

Name	Time	Method
Regional (nodal) disease-free survival	From randomization to end of year 5	Average number of participants who are experiencing regional disease-free survival at 3 and 5 years.
Local recurrence-free survival	From randomization to end of year 5	The average length of time (in months) from the date of randomization to local recurrence.
Melanoma-specific survival	From randomization to end of year 5	The average length of time (in months) from date of randomization to death.
Postoperative pain	Up to 30 days after surgery	Measured by numeric rating scale (0-10).
Quality of life	Up to postoperative day 90	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 fo life (QOL). FACE-Q includes 5 independently functioning scales and 2 checklists that measure outcomes important to patients from their perspective.
Surgical complication rate	Up to postoperative day 90	Defined as the proportion of patients experiencing a surgical complication.
Frequency of complex reconstruction	Immediately after surgery	Defined as the proportion of patients receiving any flap or graft reconstruction.
Defect size	Immediately after surgery	The size of the defect is measured as the greatest dimension of the final wound multiplied by the dimension perpendicular to the greatest dimension.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States