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

NCT06673095 | Recruiting

• 2 other identifiers: STUDY00027175NCI-2024-08327
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Stage IA Cutaneous Melanoma AJCC v8; Clinical Stage IB Cutaneous Melanoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Regional (nodal) disease-free survival

  From randomization to end of year 5

• Local recurrence-free survival

  From randomization to end of year 5

• Melanoma-specific survival

  From randomization to end of year 5

• Postoperative pain

  Up to 30 days after surgery

• Quality of life

  Up to postoperative day 90

Study Arms (2)

Arm I (narrow margin excision)

EXPERIMENTAL

Patients undergo narrow margin excision on study. Patients may optionally undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Excision; Other: Survey Administration

Arm II (wide margin excision)

ACTIVE COMPARATOR

Patients undergo wide margin excision on study. Patients may optionally undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Excision; Other: Survey Administration

Interventions

Excision PROCEDURE

Undergo narrow margin excision

Also known as: Abscission, Extirpation, Surgical Removal

Arm I (narrow margin excision)

Survey Administration OTHER

Ancillary studies

Arm I (narrow margin excision); Arm II (wide margin excision)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (narrow margin excision); Arm II (wide margin excision)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40921901 DERIVED

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Wesley Yu

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wesley Yu, M.D.

CONTACT

503-418-9386; yuwe@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 4, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)