Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Excision
Procedure/SurgeryUndergo narrow margin excision
Excision
Procedure/SurgeryUndergo wide margin excision
Survey Administration
Other interventionAncillary studies
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Arm I (narrow margin excision)Experimental treatment 3 interventions
Group B: Arm II (wide margin excision)Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
Local 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 3Secondary outcomes
1
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 52
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 53
Melanoma-specific survival
The average length of time (in months) from date of randomization to death.
Time frame
From randomization to end of year 54
Postoperative pain
Measured by numeric rating scale (0-10).
Time frame
Up to 30 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
OHSU Knight Cancer Institute
Lead sponsor
Oregon Health and Science University
Collaborator
Source ClinicalTrials.gov