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NCT03034395 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT03034395
Other study ID # IIT-2016-JM-MEL-T2Margins
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2017
Est. completion date November 4, 2020

Study information
Verified date April 2021
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date November 4, 2020
Est. primary completion date May 3, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Wide Local Excision
Surgery

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)
Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Quality of life following surgery Measured by FACT-Melanoma Surgery Subscale One month post-surgery
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