Clinical trial NCT06673095: Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
Official title: ICEMAN (Intelligent Choice of Excision Margin): A Randomized Controlled Trial of Narrow Excision Versus Wide Excision for Adults With Primary Invasive Cutaneous Melanomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clinical Stage IA Cutaneous Melanoma AJCC v8
Clinical Stage IB Cutaneous Melanoma AJCC v8
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2024-11-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Local recurrence rate
timeFrame: From randomization to end of year 3
Secondary outcomes:
measure: Regional (nodal) disease-free survival
timeFrame: From randomization to end of year 5
measure: Local recurrence-free survival
timeFrame: From randomization to end of year 5
measure: Melanoma-specific survival
timeFrame: From randomization to end of year 5
measure: Postoperative pain
timeFrame: Up to 30 days after surgery
measure: Quality of life
timeFrame: Up to postoperative day 90
measure: Surgical complication rate
timeFrame: Up to postoperative day 90
measure: Frequency of complex reconstruction
timeFrame: Immediately after surgery
measure: Defect size
timeFrame: Immediately after surgery
measure: Number of operative/procedure days
timeFrame: Up to postoperative day 90
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Wesley Yu
role: PRINCIPAL_INVESTIGATOR
References: