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

ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Narrow Excision Versus Wide Excision for Adults With Primary Invasive Cutaneous Melanomas

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.

Study Overview

• Status: Recruiting
• Conditions: Clinical Stage IA Cutaneous Melanoma AJCC v8; Clinical Stage IB Cutaneous Melanoma AJCC v8
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Survey Administration; Procedure: Excision; Procedure: Excision

Detailed 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 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
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paige Smith; Phone Number: 503-418-4268; Email: smitpaig@ohsu.edu

Study Locations

• United States
  • California
    • Davis, California, United States, 95817
      • Not yet recruiting
      • University of California, Davis
      • Principal Investigator: Daniel Eisen, MD
      • Contact: Daniel Eisen, MD; Email: dbeisen@health.ucdavis.edu
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Not yet recruiting
      • University of Kentucky/Markey Cancer Center
      • Contact: Leah Winer, M.D.; Email: leah.winer@uky.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Not yet recruiting
      • University of Michigan
      • Contact: Tiffany Libtow; Email: thulett@med.umich.edu
      • Principal Investigator: Michael Davis, MD
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Bryan Carroll, MD; Email: Bryan.Carroll@UHhospitals.org
      • Principal Investigator: Bryan Carroll, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
      • Contact: Paige Smith; Phone Number: 503-418-4268; Email: smitpaig@ohsu.edu
      • Principal Investigator: Noah Hornick, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (narrow margin excision); Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Survey Administration; Ancillary studies; Procedure: Excision; Undergo narrow margin excision; Other Names: Abscission; Extirpation; Surgical Removal; Procedure: Excision; Undergo wide margin excision; Other Names: Abscission; Extirpation; Surgical Removal
Active Comparator: Arm II (wide margin excision); Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Survey Administration; Ancillary studies; Procedure: Excision; Undergo narrow margin excision; Other Names: Abscission; Extirpation; Surgical Removal; Procedure: Excision; Undergo wide margin excision; Other Names: Abscission; Extirpation; Surgical Removal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional (nodal) disease-free survival	Average number of participants who are experiencing regional disease-free survival at 3 and 5 years.	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.	From randomization to end of year 5
Melanoma-specific survival	The average length of time (in months) from date of randomization to death.	From randomization to end of year 5
Postoperative pain	Measured by numeric rating scale (0-10).	Up to 30 days after surgery
Surgical complication rate	Defined as the proportion of patients experiencing a surgical complication.	Up to postoperative day 90
Frequency of complex reconstruction	Defined as the proportion of patients receiving any flap or graft reconstruction.	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.	Immediately 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.	Up to postoperative day 90
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).	Up to postoperative day 90

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Noah Hornick, M.D., OHSU Knight Cancer Institute

Publications and helpful links

General Publications

• Bichakjian CK, Swetter SM, Carroll BT, Vidal NY, Simons EA, Vetto JT, Yu WY. ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Adaptive Narrow Excision Versus Wide Excision for Adults with AJCC Stage I Cutaneous Melanoma. Ann Surg Oncol. 2025 Dec;32(13):9488-9490. doi: 10.1245/s10434-025-18282-w. Epub 2025 Sep 8.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma, Cutaneous Malignant; Melanoma; Skin Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID Numbers: STUDY00027175 (Other Identifier: OHSU Knight Cancer Institute); NCI-2024-08327 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No