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

Malignant Melanoma Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03034395
Study type Interventional
Source University of Kansas Medical Center
Contact
Status Completed
Phase N/A
Start date January 30, 2017
Completion date November 4, 2020
View Details
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