Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma

Study Overview
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Brief Summary
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This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.

Detailed Description
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After randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure considerations may require removal of additional tissue for non-oncologic purposes. As per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.

Official Title
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Pilot Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Procedure: Wide Local Excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven T2 malignant melanoma. Eastern Cooperative Oncology Group (ECOG) score of 0-2. Exclusion Criteria: Visible additional disease that suggests a greater than T2 malignant melanoma Unable to tolerate general anesthesia Evidence of distant metastatic disease Melanoma located on face or digits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wide Local Excision 1cm<br> | Procedure: Wide Local Excision<br>* Surgery<br>|
| Other: Wide Local Excision 2cm<br> | Procedure: Wide Local Excision<br>* Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma. | Number of patients who agree to participate | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence (disease free survival) | Subjects will be evaluated at 4 month intervals for 2 years and then at 4-6 month intervals for an additional 3 years to evaluate for evidence of disease recurrence. | Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years | 
| Quality of life following surgery | Measured by FACT-Melanoma Surgery Subscale | One month post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, cT2N0M0