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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2020-11-04

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.

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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.

Conditions

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Malignant Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wide Local Excision 1cm

Group Type OTHER

Wide Local Excision

Intervention Type PROCEDURE

Surgery

Wide Local Excision 2cm

Group Type OTHER

Wide Local Excision

Intervention Type PROCEDURE

Surgery

Interventions

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Wide Local Excision

Surgery

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No